�ݺ�ߣshows by User: santoshnarla

�ݺ�ߣshows by User: santoshnarla / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: santoshnarla / Sun, 24 Nov 2019 13:11:01 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: santoshnarla Regulatory affairs and Intellectual Property Rights /slideshow/regulatory-affairs-and-intellectual-property-rights/197016344 regulatoryaffairsipr-191124131102
Formulation Regulatory Affairs and Intellectual Property Rights]]>
Formulation Regulatory Affairs and Intellectual Property Rights]]> Sun, 24 Nov 2019 13:11:01 GMT /slideshow/regulatory-affairs-and-intellectual-property-rights/197016344 santoshnarla@slideshare.net(santoshnarla) Regulatory affairs and Intellectual Property Rights santoshnarla Formulation Regulatory Affairs and Intellectual Property Rights <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/regulatoryaffairsipr-191124131102-thumbnail.jpg?width=120&height=120&fit=bounds" /> Formulation Regulatory Affairs and Intellectual Property Rights

Regulatory affairs and Intellectual Property Rights from santoshnarla

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0 Anda refuse to receive /santoshnarla/anda-refuse-to-receive anda-refusetoreceive-171203100444
Refuse to Receive standards of ANDAs. This presentation is based on CDER guidance on RTR and recent Draft Q&A.]]>
Refuse to Receive standards of ANDAs. This presentation is based on CDER guidance on RTR and recent Draft Q&A.]]> Sun, 03 Dec 2017 10:04:44 GMT /santoshnarla/anda-refuse-to-receive santoshnarla@slideshare.net(santoshnarla) Anda refuse to receive santoshnarla Refuse to Receive standards of ANDAs. This presentation is based on CDER guidance on RTR and recent Draft Q&A. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/anda-refusetoreceive-171203100444-thumbnail.jpg?width=120&height=120&fit=bounds" /> Refuse to Receive standards of ANDAs. This presentation is based on CDER guidance on RTR and recent Draft Q&A.

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0 Data integrity - Regulatory Perspective and Challenges: /santoshnarla/data-integrity-regulatory-perspective-and-challenges dataintegrity-dr-171107160733
Data Integrity: Regulatory Perspective and Challenges. This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges. ]]>
Data Integrity: Regulatory Perspective and Challenges. This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges. ]]> Tue, 07 Nov 2017 16:07:33 GMT /santoshnarla/data-integrity-regulatory-perspective-and-challenges santoshnarla@slideshare.net(santoshnarla) Data integrity - Regulatory Perspective and Challenges: santoshnarla Data Integrity: Regulatory Perspective and Challenges. This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/dataintegrity-dr-171107160733-thumbnail.jpg?width=120&height=120&fit=bounds" /> Data Integrity: Regulatory Perspective and Challenges. This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges.

Data integrity - Regulatory Perspective and Challenges: from santoshnarla

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0 Process validation of drug product /slideshow/process-validation-of-drug-product/47120282 processvalidationofdrugproduct-150417111927-conversion-gate01
Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.]]>
Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.]]> Fri, 17 Apr 2015 11:19:27 GMT /slideshow/process-validation-of-drug-product/47120282 santoshnarla@slideshare.net(santoshnarla) Process validation of drug product santoshnarla Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/processvalidationofdrugproduct-150417111927-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.

Process validation of drug product from santoshnarla

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0 Ich q3 d elemental impurities /slideshow/ich-q3-d-elemental-impurities-47120046/47120046 ichq3delementalimpurities-150417111302-conversion-gate01
New guidelines relating to elemental impurities from the International Conference on Harmonization (ICH), Q3D Guideline for Elemental Impurities have presented the pharmaceutical industry with new challenges. This new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.]]>
New guidelines relating to elemental impurities from the International Conference on Harmonization (ICH), Q3D Guideline for Elemental Impurities have presented the pharmaceutical industry with new challenges. This new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.]]> Fri, 17 Apr 2015 11:13:02 GMT /slideshow/ich-q3-d-elemental-impurities-47120046/47120046 santoshnarla@slideshare.net(santoshnarla) Ich q3 d elemental impurities santoshnarla New guidelines relating to elemental impurities from the International Conference on Harmonization (ICH), Q3D Guideline for Elemental Impurities have presented the pharmaceutical industry with new challenges. This new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ichq3delementalimpurities-150417111302-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> New guidelines relating to elemental impurities from the International Conference on Harmonization (ICH), Q3D Guideline for Elemental Impurities have presented the pharmaceutical industry with new challenges. This new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

Ich q3 d elemental impurities from santoshnarla

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0 Genotoxic impurities /santoshnarla/genotoxic-impurities-13944819 genotoxicimpurities-120811112204-phpapp02
Genotoxic Impurities, Background, Controlling of genotoxic impurities.]]>
Genotoxic Impurities, Background, Controlling of genotoxic impurities.]]> Sat, 11 Aug 2012 11:22:02 GMT /santoshnarla/genotoxic-impurities-13944819 santoshnarla@slideshare.net(santoshnarla) Genotoxic impurities santoshnarla Genotoxic Impurities, Background, Controlling of genotoxic impurities. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/genotoxicimpurities-120811112204-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Genotoxic Impurities, Background, Controlling of genotoxic impurities.

Genotoxic impurities from santoshnarla

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0 Marketing authorization /slideshow/marketing-authorization/13030855 marketingauthorization-120522105423-phpapp02
Marketing authorisation, decentralised procedure, national authorization, european reference, EU regulatory filling]]>
Marketing authorisation, decentralised procedure, national authorization, european reference, EU regulatory filling]]> Tue, 22 May 2012 10:54:22 GMT /slideshow/marketing-authorization/13030855 santoshnarla@slideshare.net(santoshnarla) Marketing authorization santoshnarla Marketing authorisation, decentralised procedure, national authorization, european reference, EU regulatory filling <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/marketingauthorization-120522105423-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Marketing authorisation, decentralised procedure, national authorization, european reference, EU regulatory filling

Marketing authorization from santoshnarla

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0 https://cdn.slidesharecdn.com/profile-photo-santoshnarla-48x48.jpg?cb=1632146386 https://cdn.slidesharecdn.com/ss_thumbnails/regulatoryaffairsipr-191124131102-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/regulatory-affairs-and-intellectual-property-rights/197016344 Regulatory affairs and... https://cdn.slidesharecdn.com/ss_thumbnails/anda-refusetoreceive-171203100444-thumbnail.jpg?width=320&height=320&fit=bounds santoshnarla/anda-refuse-to-receive Anda refuse to receive https://cdn.slidesharecdn.com/ss_thumbnails/dataintegrity-dr-171107160733-thumbnail.jpg?width=320&height=320&fit=bounds santoshnarla/data-integrity-regulatory-perspective-and-challenges Data integrity - Regul...