�ݺ�ߣshows by User: a2zpharmsci

�ݺ�ߣshows by User: a2zpharmsci / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: a2zpharmsci / Wed, 07 May 2025 05:26:40 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: a2zpharmsci From Intermittent to Flow SMART Integrity Lessons and Commonsense /slideshow/from-intermittent-to-flow-smart-integrity-lessons-and-commonsense/278821400 fromintermittenttoflowsmart7may2025finalajaz-250507052640-f3049f19
Delivered at the 2025 Summit on Innovations in Controlled Release, Bioavailability Enhancement & Continuous Manufacturing. We are navigating a world in which the very systems we’ve built—scientific, regulatory, organizational—are failing to inspire the trust they once commanded. These systems, like our supply chains and our quality assurance processes, are too often clogged with intermittency: stop-start efforts, siloed knowledge, and half-hearted feedback loops. In such a state, even well-intentioned compliance becomes performative rather than transformative. We talk often of Corrective and Preventive Action (CAPA). But too many systems remain corrective without being truly preventive, and preventive without being truly reflective. What’s missing? A mindset of flow—not just in materials or data, but in consciousness. “SMART isn't just a tool. It’s a mindset for transforming how we know, how we lead, and how we flow.” If you review talk, I invite you to share: What resonated most with you? What are you doing to shift from intermittent correction to preventive flow? Where in your system—or your own practice—do you feel trust is fragile? Let’s turn these reflections into momentum. Let’s restore the flow.]]>
Delivered at the 2025 Summit on Innovations in Controlled Release, Bioavailability Enhancement & Continuous Manufacturing. We are navigating a world in which the very systems we’ve built—scientific, regulatory, organizational—are failing to inspire the trust they once commanded. These systems, like our supply chains and our quality assurance processes, are too often clogged with intermittency: stop-start efforts, siloed knowledge, and half-hearted feedback loops. In such a state, even well-intentioned compliance becomes performative rather than transformative. We talk often of Corrective and Preventive Action (CAPA). But too many systems remain corrective without being truly preventive, and preventive without being truly reflective. What’s missing? A mindset of flow—not just in materials or data, but in consciousness. “SMART isn't just a tool. It’s a mindset for transforming how we know, how we lead, and how we flow.” If you review talk, I invite you to share: What resonated most with you? What are you doing to shift from intermittent correction to preventive flow? Where in your system—or your own practice—do you feel trust is fragile? Let’s turn these reflections into momentum. Let’s restore the flow.]]> Wed, 07 May 2025 05:26:40 GMT /slideshow/from-intermittent-to-flow-smart-integrity-lessons-and-commonsense/278821400 a2zpharmsci@slideshare.net(a2zpharmsci) From Intermittent to Flow SMART Integrity Lessons and Commonsense a2zpharmsci Delivered at the 2025 Summit on Innovations in Controlled Release, Bioavailability Enhancement & Continuous Manufacturing. We are navigating a world in which the very systems we’ve built—scientific, regulatory, organizational—are failing to inspire the trust they once commanded. These systems, like our supply chains and our quality assurance processes, are too often clogged with intermittency: stop-start efforts, siloed knowledge, and half-hearted feedback loops. In such a state, even well-intentioned compliance becomes performative rather than transformative. We talk often of Corrective and Preventive Action (CAPA). But too many systems remain corrective without being truly preventive, and preventive without being truly reflective. What’s missing? A mindset of flow—not just in materials or data, but in consciousness. “SMART isn't just a tool. It’s a mindset for transforming how we know, how we lead, and how we flow.” If you review talk, I invite you to share: What resonated most with you? What are you doing to shift from intermittent correction to preventive flow? Where in your system—or your own practice—do you feel trust is fragile? Let’s turn these reflections into momentum. Let’s restore the flow. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fromintermittenttoflowsmart7may2025finalajaz-250507052640-f3049f19-thumbnail.jpg?width=120&height=120&fit=bounds" /> Delivered at the 2025 Summit on Innovations in Controlled Release, Bioavailability Enhancement & Continuous Manufacturing. We are navigating a world in which the very systems we’ve built—scientific, regulatory, organizational—are failing to inspire the trust they once commanded. These systems, like our supply chains and our quality assurance processes, are too often clogged with intermittency: stop-start efforts, siloed knowledge, and half-hearted feedback loops. In such a state, even well-intentioned compliance becomes performative rather than transformative. We talk often of Corrective and Preventive Action (CAPA). But too many systems remain corrective without being truly preventive, and preventive without being truly reflective. What’s missing? A mindset of flow—not just in materials or data, but in consciousness. “SMART isn't just a tool. It’s a mindset for transforming how we know, how we lead, and how we flow.” If you review talk, I invite you to share: What resonated most with you? What are you doing to shift from intermittent correction to preventive flow? Where in your system—or your own practice—do you feel trust is fragile? Let’s turn these reflections into momentum. Let’s restore the flow.

From Intermittent to Flow SMART Integrity Lessons and Commonsense from Ajaz Hussain

]]> 142 0 https://cdn.slidesharecdn.com/ss_thumbnails/fromintermittenttoflowsmart7may2025finalajaz-250507052640-f3049f19-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Blind Spots in AI and Formulation Science Knowledge Pyramid (Updated Perspective)) /slideshow/blind-spots-in-ai-and-formulation-science-knowledge-pyramid-updated-perspective/276296709 blindspotsinaiandformulationscienceknowledgepyramid-250305092954-894ef9a1
This presentation delves into the systemic blind spots within pharmaceutical science and regulatory systems, emphasizing the significance of "inactive ingredients" and their influence on therapeutic equivalence. These blind spots, indicative of normalized systemic failures, go beyond mere chance occurrences and are ingrained deeply enough to compromise decision-making processes and erode trust. Historical instances like the 1938 FD&C Act and the Generic Drug Scandals underscore how crisis-triggered reforms often fail to address the fundamental issues, perpetuating inefficiencies and hazards. The narrative advocates a shift from reactive crisis management to proactive, adaptable systems prioritizing continuous enhancement. Key hurdles involve challenging outdated assumptions regarding bioavailability, inadequately funded research ventures, and the impact of vague language in regulatory frameworks. The rise of large language models (LLMs) presents promising solutions, albeit with accompanying risks necessitating thorough validation and seamless integration. Tackling these blind spots demands a holistic approach, embracing adaptive learning and a steadfast commitment to self-improvement. By nurturing curiosity, refining regulatory terminology, and judiciously harnessing new technologies, the pharmaceutical sector can progress towards better public health service delivery and ensure the safety, efficacy, and real-world impact of drug products.]]>
This presentation delves into the systemic blind spots within pharmaceutical science and regulatory systems, emphasizing the significance of "inactive ingredients" and their influence on therapeutic equivalence. These blind spots, indicative of normalized systemic failures, go beyond mere chance occurrences and are ingrained deeply enough to compromise decision-making processes and erode trust. Historical instances like the 1938 FD&C Act and the Generic Drug Scandals underscore how crisis-triggered reforms often fail to address the fundamental issues, perpetuating inefficiencies and hazards. The narrative advocates a shift from reactive crisis management to proactive, adaptable systems prioritizing continuous enhancement. Key hurdles involve challenging outdated assumptions regarding bioavailability, inadequately funded research ventures, and the impact of vague language in regulatory frameworks. The rise of large language models (LLMs) presents promising solutions, albeit with accompanying risks necessitating thorough validation and seamless integration. Tackling these blind spots demands a holistic approach, embracing adaptive learning and a steadfast commitment to self-improvement. By nurturing curiosity, refining regulatory terminology, and judiciously harnessing new technologies, the pharmaceutical sector can progress towards better public health service delivery and ensure the safety, efficacy, and real-world impact of drug products.]]> Wed, 05 Mar 2025 09:29:54 GMT /slideshow/blind-spots-in-ai-and-formulation-science-knowledge-pyramid-updated-perspective/276296709 a2zpharmsci@slideshare.net(a2zpharmsci) Blind Spots in AI and Formulation Science Knowledge Pyramid (Updated Perspective)) a2zpharmsci This presentation delves into the systemic blind spots within pharmaceutical science and regulatory systems, emphasizing the significance of "inactive ingredients" and their influence on therapeutic equivalence. These blind spots, indicative of normalized systemic failures, go beyond mere chance occurrences and are ingrained deeply enough to compromise decision-making processes and erode trust. Historical instances like the 1938 FD&C Act and the Generic Drug Scandals underscore how crisis-triggered reforms often fail to address the fundamental issues, perpetuating inefficiencies and hazards. The narrative advocates a shift from reactive crisis management to proactive, adaptable systems prioritizing continuous enhancement. Key hurdles involve challenging outdated assumptions regarding bioavailability, inadequately funded research ventures, and the impact of vague language in regulatory frameworks. The rise of large language models (LLMs) presents promising solutions, albeit with accompanying risks necessitating thorough validation and seamless integration. Tackling these blind spots demands a holistic approach, embracing adaptive learning and a steadfast commitment to self-improvement. By nurturing curiosity, refining regulatory terminology, and judiciously harnessing new technologies, the pharmaceutical sector can progress towards better public health service delivery and ensure the safety, efficacy, and real-world impact of drug products. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/blindspotsinaiandformulationscienceknowledgepyramid-250305092954-894ef9a1-thumbnail.jpg?width=120&height=120&fit=bounds" /> This presentation delves into the systemic blind spots within pharmaceutical science and regulatory systems, emphasizing the significance of "inactive ingredients" and their influence on therapeutic equivalence. These blind spots, indicative of normalized systemic failures, go beyond mere chance occurrences and are ingrained deeply enough to compromise decision-making processes and erode trust. Historical instances like the 1938 FD&C Act and the Generic Drug Scandals underscore how crisis-triggered reforms often fail to address the fundamental issues, perpetuating inefficiencies and hazards. The narrative advocates a shift from reactive crisis management to proactive, adaptable systems prioritizing continuous enhancement. Key hurdles involve challenging outdated assumptions regarding bioavailability, inadequately funded research ventures, and the impact of vague language in regulatory frameworks. The rise of large language models (LLMs) presents promising solutions, albeit with accompanying risks necessitating thorough validation and seamless integration. Tackling these blind spots demands a holistic approach, embracing adaptive learning and a steadfast commitment to self-improvement. By nurturing curiosity, refining regulatory terminology, and judiciously harnessing new technologies, the pharmaceutical sector can progress towards better public health service delivery and ensure the safety, efficacy, and real-world impact of drug products.

Blind Spots in AI and Formulation Science Knowledge Pyramid (Updated Perspective)) from Ajaz Hussain

]]> 818 0 https://cdn.slidesharecdn.com/ss_thumbnails/blindspotsinaiandformulationscienceknowledgepyramid-250305092954-894ef9a1-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Blind spots in AI and Formulation Science, IFPAC 2025.pdf /slideshow/blind-spots-in-ai-and-formulation-science-ifpac-2025-pdf/276188107 blindspotsinaiandformulationscience-250302144810-a806558a
The intersection of AI and pharmaceutical formulation science highlights significant blind spots—systemic gaps in pharmaceutical development, regulatory oversight, quality assurance, and the ethical use of AI—that could jeopardize patient safety and undermine public trust. To move forward effectively, we must address these normalized blind spots, which may arise from outdated assumptions, errors, gaps in previous knowledge, and biases in language or regulatory inertia. This is essential to ensure that AI and formulation science are developed as tools for patient-centered and ethical healthcare.]]>
The intersection of AI and pharmaceutical formulation science highlights significant blind spots—systemic gaps in pharmaceutical development, regulatory oversight, quality assurance, and the ethical use of AI—that could jeopardize patient safety and undermine public trust. To move forward effectively, we must address these normalized blind spots, which may arise from outdated assumptions, errors, gaps in previous knowledge, and biases in language or regulatory inertia. This is essential to ensure that AI and formulation science are developed as tools for patient-centered and ethical healthcare.]]> Sun, 02 Mar 2025 14:48:10 GMT /slideshow/blind-spots-in-ai-and-formulation-science-ifpac-2025-pdf/276188107 a2zpharmsci@slideshare.net(a2zpharmsci) Blind spots in AI and Formulation Science, IFPAC 2025.pdf a2zpharmsci The intersection of AI and pharmaceutical formulation science highlights significant blind spots—systemic gaps in pharmaceutical development, regulatory oversight, quality assurance, and the ethical use of AI—that could jeopardize patient safety and undermine public trust. To move forward effectively, we must address these normalized blind spots, which may arise from outdated assumptions, errors, gaps in previous knowledge, and biases in language or regulatory inertia. This is essential to ensure that AI and formulation science are developed as tools for patient-centered and ethical healthcare. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/blindspotsinaiandformulationscience-250302144810-a806558a-thumbnail.jpg?width=120&height=120&fit=bounds" /> The intersection of AI and pharmaceutical formulation science highlights significant blind spots—systemic gaps in pharmaceutical development, regulatory oversight, quality assurance, and the ethical use of AI—that could jeopardize patient safety and undermine public trust. To move forward effectively, we must address these normalized blind spots, which may arise from outdated assumptions, errors, gaps in previous knowledge, and biases in language or regulatory inertia. This is essential to ensure that AI and formulation science are developed as tools for patient-centered and ethical healthcare.

Blind spots in AI and Formulation Science, IFPAC 2025.pdf from Ajaz Hussain

]]> 1114 0 https://cdn.slidesharecdn.com/ss_thumbnails/blindspotsinaiandformulationscience-250302144810-a806558a-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Boosting FDA Warning Letters Regulatory Analysis with Generative AI Part II Ajaz Hussain 25 October 2024.pdf /slideshow/boosting-fda-warning-letters-regulatory-analysis-with-generative-ai-part-ii-ajaz-hussain-25-october-2024-pdf/272721686 boostingfdawarninglettersregulatoryanalysiswithgenerativeaipartiiajazhussain25october2024-241025090929-ccc487e8
This is a work-in-progress collaboration motivated by a vision for “CAFD” 30 years ago [Hussain, A. S., Shivanand, P., & Johnson, R. D. (1994). Application of Neural Computing in Pharmaceutical Product Development: Computer Aided Formulation Design. Drug Development and Industrial Pharmacy, 20(10), 1739–1752. https://doi.org/10.3109/03639049409038390 ]. It includes reasoning of a stand-alone ChatGPT-4 a black box. What and how you interrogate – can be a valuable tool at the novice level to expand awareness. It can pass standardized tests easily, can it solve real-world “regulated” pharmaceutical manufacturing problems remains an open question. There is a clear need for more work in strategic and structured problem-solving, such as outlining a strategy to prevent a Warning Letter. ]]>
This is a work-in-progress collaboration motivated by a vision for “CAFD” 30 years ago [Hussain, A. S., Shivanand, P., & Johnson, R. D. (1994). Application of Neural Computing in Pharmaceutical Product Development: Computer Aided Formulation Design. Drug Development and Industrial Pharmacy, 20(10), 1739–1752. https://doi.org/10.3109/03639049409038390 ]. It includes reasoning of a stand-alone ChatGPT-4 a black box. What and how you interrogate – can be a valuable tool at the novice level to expand awareness. It can pass standardized tests easily, can it solve real-world “regulated” pharmaceutical manufacturing problems remains an open question. There is a clear need for more work in strategic and structured problem-solving, such as outlining a strategy to prevent a Warning Letter. ]]> Fri, 25 Oct 2024 09:09:29 GMT /slideshow/boosting-fda-warning-letters-regulatory-analysis-with-generative-ai-part-ii-ajaz-hussain-25-october-2024-pdf/272721686 a2zpharmsci@slideshare.net(a2zpharmsci) Boosting FDA Warning Letters Regulatory Analysis with Generative AI Part II Ajaz Hussain 25 October 2024.pdf a2zpharmsci This is a work-in-progress collaboration motivated by a vision for “CAFD” 30 years ago [Hussain, A. S., Shivanand, P., & Johnson, R. D. (1994). Application of Neural Computing in Pharmaceutical Product Development: Computer Aided Formulation Design. Drug Development and Industrial Pharmacy, 20(10), 1739–1752. https://doi.org/10.3109/03639049409038390 ]. It includes reasoning of a stand-alone ChatGPT-4 a black box. What and how you interrogate – can be a valuable tool at the novice level to expand awareness. It can pass standardized tests easily, can it solve real-world “regulated” pharmaceutical manufacturing problems remains an open question. There is a clear need for more work in strategic and structured problem-solving, such as outlining a strategy to prevent a Warning Letter. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/boostingfdawarninglettersregulatoryanalysiswithgenerativeaipartiiajazhussain25october2024-241025090929-ccc487e8-thumbnail.jpg?width=120&height=120&fit=bounds" /> This is a work-in-progress collaboration motivated by a vision for “CAFD” 30 years ago [Hussain, A. S., Shivanand, P., & Johnson, R. D. (1994). Application of Neural Computing in Pharmaceutical Product Development: Computer Aided Formulation Design. Drug Development and Industrial Pharmacy, 20(10), 1739–1752. https://doi.org/10.3109/03639049409038390 ]. It includes reasoning of a stand-alone ChatGPT-4 a black box. What and how you interrogate – can be a valuable tool at the novice level to expand awareness. It can pass standardized tests easily, can it solve real-world “regulated” pharmaceutical manufacturing problems remains an open question. There is a clear need for more work in strategic and structured problem-solving, such as outlining a strategy to prevent a Warning Letter.

Boosting FDA Warning Letters Regulatory Analysis with Generative AI Part II Ajaz Hussain 25 October 2024.pdf from Ajaz Hussain

]]> 204 0 https://cdn.slidesharecdn.com/ss_thumbnails/boostingfdawarninglettersregulatoryanalysiswithgenerativeaipartiiajazhussain25october2024-241025090929-ccc487e8-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Formulating with Artificial and Natural Integrity Fifth Order of Development 10242024.pdf /slideshow/formulating-with-artificial-and-natural-integrity-fifth-order-of-development-10242024-pdf/272688146 formulatingwithartificialandnaturalintegrityfifthorderofdevelopment10242024-241024083303-fea542e1
Welcome to my presentation, 'Formulating with Artificial and Natural Integrity: The Fifth Order of Pharmaceutical Development,' as part of the VAMs 2.0 AI-Enabled Development and Commercialization Conference. In it I share insights into how artificial intelligence and natural human development principles can advance pharmaceutical practices.]]>
Welcome to my presentation, 'Formulating with Artificial and Natural Integrity: The Fifth Order of Pharmaceutical Development,' as part of the VAMs 2.0 AI-Enabled Development and Commercialization Conference. In it I share insights into how artificial intelligence and natural human development principles can advance pharmaceutical practices.]]> Thu, 24 Oct 2024 08:33:03 GMT /slideshow/formulating-with-artificial-and-natural-integrity-fifth-order-of-development-10242024-pdf/272688146 a2zpharmsci@slideshare.net(a2zpharmsci) Formulating with Artificial and Natural Integrity Fifth Order of Development 10242024.pdf a2zpharmsci Welcome to my presentation, 'Formulating with Artificial and Natural Integrity: The Fifth Order of Pharmaceutical Development,' as part of the VAMs 2.0 AI-Enabled Development and Commercialization Conference. In it I share insights into how artificial intelligence and natural human development principles can advance pharmaceutical practices. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/formulatingwithartificialandnaturalintegrityfifthorderofdevelopment10242024-241024083303-fea542e1-thumbnail.jpg?width=120&height=120&fit=bounds" /> Welcome to my presentation, 'Formulating with Artificial and Natural Integrity: The Fifth Order of Pharmaceutical Development,' as part of the VAMs 2.0 AI-Enabled Development and Commercialization Conference. In it I share insights into how artificial intelligence and natural human development principles can advance pharmaceutical practices.

Formulating with Artificial and Natural Integrity Fifth Order of Development 10242024.pdf from Ajaz Hussain

]]> 695 0 https://cdn.slidesharecdn.com/ss_thumbnails/formulatingwithartificialandnaturalintegrityfifthorderofdevelopment10242024-241024083303-fea542e1-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Integrity Grounds Pharma 4.0: ISPE-India /slideshow/integrity-grounds-pharma-4-0-ispe-india/271750033 integritygroundspharma4-240912064725-030686ea
Sharing slides that I used for my talk at the ISPE-Inda Pharma 4.0 conference on 12 Sept. 2024. This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. It proposes a SMART framework to incorporate Human 4.0 into a corporate management system. The SMART framework supports integrity of not only the data but also but also the knowledge and wisdom needed to achieve the goals of the ISPE's framework called Pharma 4.0™. ]]>
Sharing slides that I used for my talk at the ISPE-Inda Pharma 4.0 conference on 12 Sept. 2024. This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. It proposes a SMART framework to incorporate Human 4.0 into a corporate management system. The SMART framework supports integrity of not only the data but also but also the knowledge and wisdom needed to achieve the goals of the ISPE's framework called Pharma 4.0™. ]]> Thu, 12 Sep 2024 06:47:25 GMT /slideshow/integrity-grounds-pharma-4-0-ispe-india/271750033 a2zpharmsci@slideshare.net(a2zpharmsci) Integrity Grounds Pharma 4.0: ISPE-India a2zpharmsci Sharing slides that I used for my talk at the ISPE-Inda Pharma 4.0 conference on 12 Sept. 2024. This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. It proposes a SMART framework to incorporate Human 4.0 into a corporate management system. The SMART framework supports integrity of not only the data but also but also the knowledge and wisdom needed to achieve the goals of the ISPE's framework called Pharma 4.0™. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/integritygroundspharma4-240912064725-030686ea-thumbnail.jpg?width=120&height=120&fit=bounds" /> Sharing slides that I used for my talk at the ISPE-Inda Pharma 4.0 conference on 12 Sept. 2024. This talk emphasizes the importance of applying the "Human 4.0" criteria, which refers to the initiative's human element. It proposes a SMART framework to incorporate Human 4.0 into a corporate management system. The SMART framework supports integrity of not only the data but also but also the knowledge and wisdom needed to achieve the goals of the ISPE's framework called Pharma 4.0™.

Integrity Grounds Pharma 4.0: ISPE-India from Ajaz Hussain

]]> 1147 0 https://cdn.slidesharecdn.com/ss_thumbnails/integritygroundspharma4-240912064725-030686ea-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Minding the Pharma Delta Error in the Post-truth World.pdf /slideshow/minding-the-pharma-delta-error-in-the-post-truth-world-pdf/270103811 mindingthedeltaerror-240707093001-988ad607
Alas, my smartphone seems to evolve more efficiently than I do. What should I do? Strive to be wiser today than yesterday!]]>
Alas, my smartphone seems to evolve more efficiently than I do. What should I do? Strive to be wiser today than yesterday!]]> Sun, 07 Jul 2024 09:30:01 GMT /slideshow/minding-the-pharma-delta-error-in-the-post-truth-world-pdf/270103811 a2zpharmsci@slideshare.net(a2zpharmsci) Minding the Pharma Delta Error in the Post-truth World.pdf a2zpharmsci Alas, my smartphone seems to evolve more efficiently than I do. What should I do? Strive to be wiser today than yesterday! <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/mindingthedeltaerror-240707093001-988ad607-thumbnail.jpg?width=120&height=120&fit=bounds" /> Alas, my smartphone seems to evolve more efficiently than I do. What should I do? Strive to be wiser today than yesterday!

Minding the Pharma Delta Error in the Post-truth World.pdf from Ajaz Hussain

]]> 75 0 https://cdn.slidesharecdn.com/ss_thumbnails/mindingthedeltaerror-240707093001-988ad607-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 A Leapfrog Need and Opportunity for mAbs /slideshow/a-leapfrog-need-and-opportunity-for-mabs/266525997 aleapfrogneedandopportunityfdathai01212024-240227220313-7041dea2
Leapfrogging on reforming mAbs policies makes sense, and doing so can be a principled duty of care. SMART Technology, SMART Professionals, SMART Services, SMART Organization.]]>
Leapfrogging on reforming mAbs policies makes sense, and doing so can be a principled duty of care. SMART Technology, SMART Professionals, SMART Services, SMART Organization.]]> Tue, 27 Feb 2024 22:03:13 GMT /slideshow/a-leapfrog-need-and-opportunity-for-mabs/266525997 a2zpharmsci@slideshare.net(a2zpharmsci) A Leapfrog Need and Opportunity for mAbs a2zpharmsci Leapfrogging on reforming mAbs policies makes sense, and doing so can be a principled duty of care. SMART Technology, SMART Professionals, SMART Services, SMART Organization. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/aleapfrogneedandopportunityfdathai01212024-240227220313-7041dea2-thumbnail.jpg?width=120&height=120&fit=bounds" /> Leapfrogging on reforming mAbs policies makes sense, and doing so can be a principled duty of care. SMART Technology, SMART Professionals, SMART Services, SMART Organization.

A Leapfrog Need and Opportunity for mAbs from Ajaz Hussain

]]> 61 0 https://cdn.slidesharecdn.com/ss_thumbnails/aleapfrogneedandopportunityfdathai01212024-240227220313-7041dea2-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 SMART Quality by Design Applications Not Submissions in 2024 /slideshow/smart-quality-by-design-applications-not-submissions-in-2024/265021622 smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde
Many generic pharma companies seeking regulatory approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. The idea of SMART "QbD in ANDApplications" (not “submission”) builds on this observation. ]]>
Many generic pharma companies seeking regulatory approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. The idea of SMART "QbD in ANDApplications" (not “submission”) builds on this observation. ]]> Sat, 30 Dec 2023 10:57:25 GMT /slideshow/smart-quality-by-design-applications-not-submissions-in-2024/265021622 a2zpharmsci@slideshare.net(a2zpharmsci) SMART Quality by Design Applications Not Submissions in 2024 a2zpharmsci Many generic pharma companies seeking regulatory approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. The idea of SMART "QbD in ANDApplications" (not “submission”) builds on this observation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde-thumbnail.jpg?width=120&height=120&fit=bounds" /> Many generic pharma companies seeking regulatory approval uncritically follow “past” practices and prior knowledge. Few, if any, correct errors and innovate to improve past expertise and techniques. The idea of SMART "QbD in ANDApplications" (not “submission”) builds on this observation.

SMART Quality by Design Applications Not Submissions in 2024 from Ajaz Hussain

]]> 93 0 https://cdn.slidesharecdn.com/ss_thumbnails/smartqualitybydesignqbdinanda12092023-231230105725-e43f5bde-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Intuitively Moving Institutions Towards Global Regulatory Resilience /slideshow/intuitively-moving-institutions-towards-global-regulatory-resilience/264201018 towardsglobalregulatoryresiliencefulldeck-231202124951-4511fe33
From my experience, how can I describe an intuitive and self-organizing social force around "attractors" patients' value to be assured of therapeutic equivalence? ]]>
From my experience, how can I describe an intuitive and self-organizing social force around "attractors" patients' value to be assured of therapeutic equivalence? ]]> Sat, 02 Dec 2023 12:49:51 GMT /slideshow/intuitively-moving-institutions-towards-global-regulatory-resilience/264201018 a2zpharmsci@slideshare.net(a2zpharmsci) Intuitively Moving Institutions Towards Global Regulatory Resilience a2zpharmsci From my experience, how can I describe an intuitive and self-organizing social force around "attractors" patients' value to be assured of therapeutic equivalence? <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/towardsglobalregulatoryresiliencefulldeck-231202124951-4511fe33-thumbnail.jpg?width=120&height=120&fit=bounds" /> From my experience, how can I describe an intuitive and self-organizing social force around "attractors" patients' value to be assured of therapeutic equivalence?

Intuitively Moving Institutions Towards Global Regulatory Resilience from Ajaz Hussain

]]> 848 0 https://cdn.slidesharecdn.com/ss_thumbnails/towardsglobalregulatoryresiliencefulldeck-231202124951-4511fe33-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Critical Importance of Pharmaceutical Traceability in the Experience.pdf /a2zpharmsci/critical-importance-of-pharmaceutical-traceability-in-the-experiencepdf criticalimportanceofpharmaceuticaltraceabilityintheexperience-231009110118-f3f83bfa
From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases. From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers.]]>
From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases. From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers.]]> Mon, 09 Oct 2023 11:01:18 GMT /a2zpharmsci/critical-importance-of-pharmaceutical-traceability-in-the-experiencepdf a2zpharmsci@slideshare.net(a2zpharmsci) Critical Importance of Pharmaceutical Traceability in the Experience.pdf a2zpharmsci From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases. From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/criticalimportanceofpharmaceuticaltraceabilityintheexperience-231009110118-f3f83bfa-thumbnail.jpg?width=120&height=120&fit=bounds" /> From a narrow viewpoint, serialization is just a process of printing an identifying number on products and shipping cases. From a long-term view, the integration of serialization numbering systems with the production line as well as the quality control procedures required to maintain the integrity of the numbers.

Critical Importance of Pharmaceutical Traceability in the Experience.pdf from Ajaz Hussain

]]> 6 0 https://cdn.slidesharecdn.com/ss_thumbnails/criticalimportanceofpharmaceuticaltraceabilityintheexperience-231009110118-f3f83bfa-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Validation 4 for Credible Pharma 4 a Keynote for Valconnect 2023.pdf /slideshow/validation-4-for-credible-pharma-4-a-keynote-for-valconnect-2023pdf/261517860 validation4forcrediblepharma4akeynoteforvalconnect2023-230927202449-f2e7c2b6
The notion of Validation 4.0 in the title of this keynote relates to the development and maturity of people and professionals, which I will elaborate on in the context of the ValGenesis experiences [of its users and service providers]. Validation 4.0 in this talk is about internal assurance, self-assurance, and self-authoring policies, plans, and procedures, ideally without the need [to wait] for FDA guidance. ]]>
The notion of Validation 4.0 in the title of this keynote relates to the development and maturity of people and professionals, which I will elaborate on in the context of the ValGenesis experiences [of its users and service providers]. Validation 4.0 in this talk is about internal assurance, self-assurance, and self-authoring policies, plans, and procedures, ideally without the need [to wait] for FDA guidance. ]]> Wed, 27 Sep 2023 20:24:49 GMT /slideshow/validation-4-for-credible-pharma-4-a-keynote-for-valconnect-2023pdf/261517860 a2zpharmsci@slideshare.net(a2zpharmsci) Validation 4 for Credible Pharma 4 a Keynote for Valconnect 2023.pdf a2zpharmsci The notion of Validation 4.0 in the title of this keynote relates to the development and maturity of people and professionals, which I will elaborate on in the context of the ValGenesis experiences [of its users and service providers]. Validation 4.0 in this talk is about internal assurance, self-assurance, and self-authoring policies, plans, and procedures, ideally without the need [to wait] for FDA guidance. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/validation4forcrediblepharma4akeynoteforvalconnect2023-230927202449-f2e7c2b6-thumbnail.jpg?width=120&height=120&fit=bounds" /> The notion of Validation 4.0 in the title of this keynote relates to the development and maturity of people and professionals, which I will elaborate on in the context of the ValGenesis experiences [of its users and service providers]. Validation 4.0 in this talk is about internal assurance, self-assurance, and self-authoring policies, plans, and procedures, ideally without the need [to wait] for FDA guidance.

Validation 4 for Credible Pharma 4 a Keynote for Valconnect 2023.pdf from Ajaz Hussain

]]> 393 0 https://cdn.slidesharecdn.com/ss_thumbnails/validation4forcrediblepharma4akeynoteforvalconnect2023-230927202449-f2e7c2b6-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf /slideshow/smart-triaxial-compaction-social-form-483-and-vai-or-oai-to-an-avengerpdf/258602215 smarttriaxialcompactionsocialform483andvaioroaitoanavenger-230624154702-ea973008
Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review? Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.” What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response? ]]>
Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review? Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.” What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response? ]]> Sat, 24 Jun 2023 15:47:02 GMT /slideshow/smart-triaxial-compaction-social-form-483-and-vai-or-oai-to-an-avengerpdf/258602215 a2zpharmsci@slideshare.net(a2zpharmsci) SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf a2zpharmsci Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review? Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.” What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response? <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/smarttriaxialcompactionsocialform483andvaioroaitoanavenger-230624154702-ea973008-thumbnail.jpg?width=120&height=120&fit=bounds" /> Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review? Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.” What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response?

SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf from Ajaz Hussain

]]> 323 0 https://cdn.slidesharecdn.com/ss_thumbnails/smarttriaxialcompactionsocialform483andvaioroaitoanavenger-230624154702-ea973008-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Statistical Thinking and Pharmaceutical Professional Development, a keynote by Ajaz NCB 2023 20 June 2023 /slideshow/statistical-thinking-and-pharmaceutical-professional-development-a-keynote-by-ajaz-ncb-2023-20-june-2023/258515238 statisticalthinkingandpharmaceuticalprofessionaldevelopmentajazncb202315june2023final-230620123019-f217620b
In adulthood, to keep maturing, one must acknowledge the elephant in the room – the emotions we feel. To feel is to experience. Experience complements our scientific training. But do we pay attention to the Integrity of our experience? A tonic for wiser statistical thinking to inform the development of pharmaceuticals and professionals. ]]>
In adulthood, to keep maturing, one must acknowledge the elephant in the room – the emotions we feel. To feel is to experience. Experience complements our scientific training. But do we pay attention to the Integrity of our experience? A tonic for wiser statistical thinking to inform the development of pharmaceuticals and professionals. ]]> Tue, 20 Jun 2023 12:30:19 GMT /slideshow/statistical-thinking-and-pharmaceutical-professional-development-a-keynote-by-ajaz-ncb-2023-20-june-2023/258515238 a2zpharmsci@slideshare.net(a2zpharmsci) Statistical Thinking and Pharmaceutical Professional Development, a keynote by Ajaz NCB 2023 20 June 2023 a2zpharmsci In adulthood, to keep maturing, one must acknowledge the elephant in the room – the emotions we feel. To feel is to experience. Experience complements our scientific training. But do we pay attention to the Integrity of our experience? A tonic for wiser statistical thinking to inform the development of pharmaceuticals and professionals. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/statisticalthinkingandpharmaceuticalprofessionaldevelopmentajazncb202315june2023final-230620123019-f217620b-thumbnail.jpg?width=120&height=120&fit=bounds" /> In adulthood, to keep maturing, one must acknowledge the elephant in the room – the emotions we feel. To feel is to experience. Experience complements our scientific training. But do we pay attention to the Integrity of our experience? A tonic for wiser statistical thinking to inform the development of pharmaceuticals and professionals.

Statistical Thinking and Pharmaceutical Professional Development, a keynote by Ajaz NCB 2023 20 June 2023 from Ajaz Hussain

]]> 571 0 https://cdn.slidesharecdn.com/ss_thumbnails/statisticalthinkingandpharmaceuticalprofessionaldevelopmentajazncb202315june2023final-230620123019-f217620b-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 An Updating Perspective on BAD I in March Madness 2023.pdf /slideshow/an-updating-perspective-on-bad-i-in-march-madness-2023pdf/256930568 updatingperspectiveonbadiinmarchmadness2023-230328141153-b18b4cda
Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional. ]]>
Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional. ]]> Tue, 28 Mar 2023 14:11:53 GMT /slideshow/an-updating-perspective-on-bad-i-in-march-madness-2023pdf/256930568 a2zpharmsci@slideshare.net(a2zpharmsci) An Updating Perspective on BAD I in March Madness 2023.pdf a2zpharmsci Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/updatingperspectiveonbadiinmarchmadness2023-230328141153-b18b4cda-thumbnail.jpg?width=120&height=120&fit=bounds" /> Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional.

An Updating Perspective on BAD I in March Madness 2023.pdf from Ajaz Hussain

]]> 589 0 https://cdn.slidesharecdn.com/ss_thumbnails/updatingperspectiveonbadiinmarchmadness2023-230328141153-b18b4cda-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Mature Managers and Management of Pharmaceutical Quality and Quantities /slideshow/mature-managers-and-management-of-pharmaceutical-quality-and-quantities/256303414 maturemanagementofqualityandquantities-230308122254-c569a879
We live in a post-truth world, and we like to think we are good. Are we? Do we not need ALCOA for the integrity of our experience? Remember: Experience means to feel; how you feel determines what you learn! Honoring my grandmother’s advice, keeping intentions clean, इरादों को साफ रखें to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way. Some of my thoughts on SMART Objective negotiations and to be better at SMART Experiencing than SMART Machines. The content describes insights from observing the immaturity of political, regulating, and management systems. Why does “immature” claim “I am mature” when it shouldn't? ]]>
We live in a post-truth world, and we like to think we are good. Are we? Do we not need ALCOA for the integrity of our experience? Remember: Experience means to feel; how you feel determines what you learn! Honoring my grandmother’s advice, keeping intentions clean, इरादों को साफ रखें to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way. Some of my thoughts on SMART Objective negotiations and to be better at SMART Experiencing than SMART Machines. The content describes insights from observing the immaturity of political, regulating, and management systems. Why does “immature” claim “I am mature” when it shouldn't? ]]> Wed, 08 Mar 2023 12:22:54 GMT /slideshow/mature-managers-and-management-of-pharmaceutical-quality-and-quantities/256303414 a2zpharmsci@slideshare.net(a2zpharmsci) Mature Managers and Management of Pharmaceutical Quality and Quantities a2zpharmsci We live in a post-truth world, and we like to think we are good. Are we? Do we not need ALCOA for the integrity of our experience? Remember: Experience means to feel; how you feel determines what you learn! Honoring my grandmother’s advice, keeping intentions clean, इरादों को साफ रखें to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way. Some of my thoughts on SMART Objective negotiations and to be better at SMART Experiencing than SMART Machines. The content describes insights from observing the immaturity of political, regulating, and management systems. Why does “immature” claim “I am mature” when it shouldn't? <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/maturemanagementofqualityandquantities-230308122254-c569a879-thumbnail.jpg?width=120&height=120&fit=bounds" /> We live in a post-truth world, and we like to think we are good. Are we? Do we not need ALCOA for the integrity of our experience? Remember: Experience means to feel; how you feel determines what you learn! Honoring my grandmother’s advice, keeping intentions clean, इरादों को साफ रखें to begin to recognize a pattern of interactions between how I feel, what I think to explain why I behaved in a certain way. Some of my thoughts on SMART Objective negotiations and to be better at SMART Experiencing than SMART Machines. The content describes insights from observing the immaturity of political, regulating, and management systems. Why does “immature” claim “I am mature” when it shouldn't?

Mature Managers and Management of Pharmaceutical Quality and Quantities from Ajaz Hussain

]]> 575 0 https://cdn.slidesharecdn.com/ss_thumbnails/maturemanagementofqualityandquantities-230308122254-c569a879-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 I-SMART Internal Validation for Continuous Professional Development.pdf /slideshow/ismart-internal-validation-for-continuous-professional-developmentpdf/253423982 i-smartinternalvalidationforcontinuousprofessionaldevelopment-221009041528-be6af02b
i-SMART: Internal validation [is] continuous [professional development]. It is a journey within and without. In the growing chaos, it is urgent and essential that we must be the change we seek in the world. Be I-SMART! #Validaiton #good ]]>
i-SMART: Internal validation [is] continuous [professional development]. It is a journey within and without. In the growing chaos, it is urgent and essential that we must be the change we seek in the world. Be I-SMART! #Validaiton #good ]]> Sun, 09 Oct 2022 04:15:28 GMT /slideshow/ismart-internal-validation-for-continuous-professional-developmentpdf/253423982 a2zpharmsci@slideshare.net(a2zpharmsci) I-SMART Internal Validation for Continuous Professional Development.pdf a2zpharmsci i-SMART: Internal validation [is] continuous [professional development]. It is a journey within and without. In the growing chaos, it is urgent and essential that we must be the change we seek in the world. Be I-SMART! #Validaiton #good <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/i-smartinternalvalidationforcontinuousprofessionaldevelopment-221009041528-be6af02b-thumbnail.jpg?width=120&height=120&fit=bounds" /> i-SMART: Internal validation [is] continuous [professional development]. It is a journey within and without. In the growing chaos, it is urgent and essential that we must be the change we seek in the world. Be I-SMART! #Validaiton #good

I-SMART Internal Validation for Continuous Professional Development.pdf from Ajaz Hussain

]]> 108 0 https://cdn.slidesharecdn.com/ss_thumbnails/i-smartinternalvalidationforcontinuousprofessionaldevelopment-221009041528-be6af02b-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 S.M.A.R.T Pharmaceuticals 2021 -2030: AI or Human? /slideshow/smart-pharmaceuticals-2021-2030-ai-or-human/250856320 s-211217093024
Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient. https://www.linkedin.com/pulse/recall-reflect-research-remember-reset-rebuild-ajaz-hussain-ph-d-/?trackingId=aF5BbJF0T5%2B036rQ7Zw3gA%3D%3D ]]>
Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient. https://www.linkedin.com/pulse/recall-reflect-research-remember-reset-rebuild-ajaz-hussain-ph-d-/?trackingId=aF5BbJF0T5%2B036rQ7Zw3gA%3D%3D ]]> Fri, 17 Dec 2021 09:30:23 GMT /slideshow/smart-pharmaceuticals-2021-2030-ai-or-human/250856320 a2zpharmsci@slideshare.net(a2zpharmsci) S.M.A.R.T Pharmaceuticals 2021 -2030: AI or Human? a2zpharmsci Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient. https://www.linkedin.com/pulse/recall-reflect-research-remember-reset-rebuild-ajaz-hussain-ph-d-/?trackingId=aF5BbJF0T5%2B036rQ7Zw3gA%3D%3D <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/s-211217093024-thumbnail.jpg?width=120&height=120&fit=bounds" /> Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient. https://www.linkedin.com/pulse/recall-reflect-research-remember-reset-rebuild-ajaz-hussain-ph-d-/?trackingId=aF5BbJF0T5%2B036rQ7Zw3gA%3D%3D

S.M.A.R.T Pharmaceuticals 2021 -2030: AI or Human? from Ajaz Hussain

]]> 244 0 https://cdn.slidesharecdn.com/ss_thumbnails/s-211217093024-thumbnail.jpg?width=120&height=120&fit=bounds presentation 000000 http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Sustain and Build a Quality Culture in Today's Realities /slideshow/sustain-and-build-a-quality-culture-in-todays-realities/250797566 sustainandbuildaqualitycultureintodaysrealities-211207112534
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems. ]]>
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems. ]]> Tue, 07 Dec 2021 11:25:34 GMT /slideshow/sustain-and-build-a-quality-culture-in-todays-realities/250797566 a2zpharmsci@slideshare.net(a2zpharmsci) Sustain and Build a Quality Culture in Today's Realities a2zpharmsci What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/sustainandbuildaqualitycultureintodaysrealities-211207112534-thumbnail.jpg?width=120&height=120&fit=bounds" /> What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems.

Sustain and Build a Quality Culture in Today's Realities from Ajaz Hussain

]]> 526 0 https://cdn.slidesharecdn.com/ss_thumbnails/sustainandbuildaqualitycultureintodaysrealities-211207112534-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “SMARTness"” /a2zpharmsci/managing-pharmaceutical-quality-in-traditional-paradigm-and-in-the-emerging-smartness ajazpharma4-2021transformingpharmaceuticalmanufacturing6october2021conferencefinal-210927235913
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”? ]]>
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”? ]]> Mon, 27 Sep 2021 23:59:12 GMT /a2zpharmsci/managing-pharmaceutical-quality-in-traditional-paradigm-and-in-the-emerging-smartness a2zpharmsci@slideshare.net(a2zpharmsci) Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “SMARTness"” a2zpharmsci The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”? <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ajazpharma4-2021transformingpharmaceuticalmanufacturing6october2021conferencefinal-210927235913-thumbnail.jpg?width=120&height=120&fit=bounds" /> The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”?

Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “SMARTness"” from Ajaz Hussain

]]> 76 0 https://cdn.slidesharecdn.com/ss_thumbnails/ajazpharma4-2021transformingpharmaceuticalmanufacturing6october2021conferencefinal-210927235913-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post

http://activitystrea.ms/schema/1.0/posted

1 https://cdn.slidesharecdn.com/profile-photo-a2zpharmsci-48x48.jpg?cb=1747408067 Self-assured to give assurance to others. www.ajazhussain.com https://cdn.slidesharecdn.com/ss_thumbnails/fromintermittenttoflowsmart7may2025finalajaz-250507052640-f3049f19-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/from-intermittent-to-flow-smart-integrity-lessons-and-commonsense/278821400 From Intermittent to F... https://cdn.slidesharecdn.com/ss_thumbnails/blindspotsinaiandformulationscienceknowledgepyramid-250305092954-894ef9a1-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/blind-spots-in-ai-and-formulation-science-knowledge-pyramid-updated-perspective/276296709 Blind Spots in AI and ... https://cdn.slidesharecdn.com/ss_thumbnails/blindspotsinaiandformulationscience-250302144810-a806558a-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/blind-spots-in-ai-and-formulation-science-ifpac-2025-pdf/276188107 Blind spots in AI and ...