際際滷shows by User: shettyuc / http://www.slideshare.net/images/logo.gif 際際滷shows by User: shettyuc / Wed, 07 Sep 2016 13:57:37 GMT 際際滷Share feed for 際際滷shows by User: shettyuc Risk Assessment for Control of Elemental Impurities. /slideshow/risk-assessment-for-control-of-elemental-impurities/65781397 riskassessmentforelementalimpurities-160907135737
This presentation highlights how Risk Assessment can be used to control Elemental Impurities. in Drug Products.]]>
This presentation highlights how Risk Assessment can be used to control Elemental Impurities. in Drug Products.]]> Wed, 07 Sep 2016 13:57:37 GMT /slideshow/risk-assessment-for-control-of-elemental-impurities/65781397 shettyuc@slideshare.net(shettyuc) Risk Assessment for Control of Elemental Impurities. shettyuc This presentation highlights how Risk Assessment can be used to control Elemental Impurities. in Drug Products. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmentforelementalimpurities-160907135737-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation highlights how Risk Assessment can be used to control Elemental Impurities. in Drug Products.
Risk Assessment for Control of Elemental Impurities. from GMP EDUCATION : Not for Profit Organization
]]> 16778 17 https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmentforelementalimpurities-160907135737-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Pharmaceutical Quality System /slideshow/pharmaceutical-quality-system/65728642 pharmaceuticalqualitysystem-160906084750
This presentation gives a summary of the New Pharmaceutical Quality System as described in ICH Q 10 guidelines. ]]>
This presentation gives a summary of the New Pharmaceutical Quality System as described in ICH Q 10 guidelines. ]]> Tue, 06 Sep 2016 08:47:50 GMT /slideshow/pharmaceutical-quality-system/65728642 shettyuc@slideshare.net(shettyuc) Pharmaceutical Quality System shettyuc This presentation gives a summary of the New Pharmaceutical Quality System as described in ICH Q 10 guidelines. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/pharmaceuticalqualitysystem-160906084750-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of the New Pharmaceutical Quality System as described in ICH Q 10 guidelines.
Pharmaceutical Quality System from GMP EDUCATION : Not for Profit Organization
]]> 26275 13 https://cdn.slidesharecdn.com/ss_thumbnails/pharmaceuticalqualitysystem-160906084750-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 New WHO Guidance on Analytical Method Validation /slideshow/new-who-guidance-on-analytical-method-validation/65678840 newwhoguidanceonanalyticalmethodvalidation-160904181526
This presentation gives a summary of the New Draft WHO Guidance on Analytical Method Validation.]]>
This presentation gives a summary of the New Draft WHO Guidance on Analytical Method Validation.]]> Sun, 04 Sep 2016 18:15:26 GMT /slideshow/new-who-guidance-on-analytical-method-validation/65678840 shettyuc@slideshare.net(shettyuc) New WHO Guidance on Analytical Method Validation shettyuc This presentation gives a summary of the New Draft WHO Guidance on Analytical Method Validation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceonanalyticalmethodvalidation-160904181526-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of the New Draft WHO Guidance on Analytical Method Validation.
New WHO Guidance on Analytical Method Validation from GMP EDUCATION : Not for Profit Organization
]]> 7687 9 https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceonanalyticalmethodvalidation-160904181526-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Blend and Content Uniformity : Industry Recommendations for Way Forward /slideshow/blend-and-content-uniformity-industry-recommendations-for-way-forward/65643763 isperecommendationsforbucu-160902232413
This presentation gives summary of ISPE -Industry Recommendations for Way Forward. ]]>
This presentation gives summary of ISPE -Industry Recommendations for Way Forward. ]]> Fri, 02 Sep 2016 23:24:13 GMT /slideshow/blend-and-content-uniformity-industry-recommendations-for-way-forward/65643763 shettyuc@slideshare.net(shettyuc) Blend and Content Uniformity : Industry Recommendations for Way Forward shettyuc This presentation gives summary of ISPE -Industry Recommendations for Way Forward. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/isperecommendationsforbucu-160902232413-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives summary of ISPE -Industry Recommendations for Way Forward.
Blend and Content Uniformity : Industry Recommendations for Way Forward from GMP EDUCATION : Not for Profit Organization
]]> 7462 4 https://cdn.slidesharecdn.com/ss_thumbnails/isperecommendationsforbucu-160902232413-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance /slideshow/content-uniformity-and-blend-uniformity-why-fda-withdrew-the-2002-guidance/65610525 contentuniformityandblenduniformity-160902003849
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.]]>
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.]]> Fri, 02 Sep 2016 00:38:48 GMT /slideshow/content-uniformity-and-blend-uniformity-why-fda-withdrew-the-2002-guidance/65610525 shettyuc@slideshare.net(shettyuc) Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance shettyuc This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/contentuniformityandblenduniformity-160902003849-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance from GMP EDUCATION : Not for Profit Organization
]]> 19935 15 https://cdn.slidesharecdn.com/ss_thumbnails/contentuniformityandblenduniformity-160902003849-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 WHO Guidance on Preparation of Laboratory Information File /slideshow/who-guidance-on-preparation-of-laboratory-information-file/65573945 whoguidanceonpreparationoflaboratoryinformationfile-160901034738
This presentation gives a summary of WHO guidance on Preparation of Laboratory Information File.]]>
This presentation gives a summary of WHO guidance on Preparation of Laboratory Information File.]]> Thu, 01 Sep 2016 03:47:38 GMT /slideshow/who-guidance-on-preparation-of-laboratory-information-file/65573945 shettyuc@slideshare.net(shettyuc) WHO Guidance on Preparation of Laboratory Information File shettyuc This presentation gives a summary of WHO guidance on Preparation of Laboratory Information File. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/whoguidanceonpreparationoflaboratoryinformationfile-160901034738-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of WHO guidance on Preparation of Laboratory Information File.
WHO Guidance on Preparation of Laboratory Information File from GMP EDUCATION : Not for Profit Organization
]]> 2435 5 https://cdn.slidesharecdn.com/ss_thumbnails/whoguidanceonpreparationoflaboratoryinformationfile-160901034738-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 US FDA Quality Metrics Technical Conformance Guide /shettyuc/us-fda-quality-metrics-technical-conformance-guide fdaqualitymetrixtechnicalconfromanceguide-160831050330
This presentation gives a summary of the New Draft FDA Quality Metrics Technical Conformance Guide.]]>
This presentation gives a summary of the New Draft FDA Quality Metrics Technical Conformance Guide.]]> Wed, 31 Aug 2016 05:03:30 GMT /shettyuc/us-fda-quality-metrics-technical-conformance-guide shettyuc@slideshare.net(shettyuc) US FDA Quality Metrics Technical Conformance Guide shettyuc This presentation gives a summary of the New Draft FDA Quality Metrics Technical Conformance Guide. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fdaqualitymetrixtechnicalconfromanceguide-160831050330-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of the New Draft FDA Quality Metrics Technical Conformance Guide.
US FDA Quality Metrics Technical Conformance Guide from GMP EDUCATION : Not for Profit Organization
]]> 1970 8 https://cdn.slidesharecdn.com/ss_thumbnails/fdaqualitymetrixtechnicalconfromanceguide-160831050330-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Calculation of Risk Priority Numbar /slideshow/calculation-of-risk-priority-numbar/65424860 ipaqrm2016final-160827184751
This presentation explains the FMEA Tool and calculation of Risk Priority Number.]]>
This presentation explains the FMEA Tool and calculation of Risk Priority Number.]]> Sat, 27 Aug 2016 18:47:51 GMT /slideshow/calculation-of-risk-priority-numbar/65424860 shettyuc@slideshare.net(shettyuc) Calculation of Risk Priority Numbar shettyuc This presentation explains the FMEA Tool and calculation of Risk Priority Number. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ipaqrm2016final-160827184751-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation explains the FMEA Tool and calculation of Risk Priority Number.
Calculation of Risk Priority Numbar from GMP EDUCATION : Not for Profit Organization
]]> 20866 12 https://cdn.slidesharecdn.com/ss_thumbnails/ipaqrm2016final-160827184751-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 New PICS Guidance on Data Integrity and Management. /slideshow/new-pics-guidance-on-data-integrity-and-management/65277734 newpicsguidanceondataintegrityandmanagement-160823140333
This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management.]]>
This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management.]]> Tue, 23 Aug 2016 14:03:33 GMT /slideshow/new-pics-guidance-on-data-integrity-and-management/65277734 shettyuc@slideshare.net(shettyuc) New PICS Guidance on Data Integrity and Management. shettyuc This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/newpicsguidanceondataintegrityandmanagement-160823140333-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation give a detailed overview of the PICS draft guidance on Data Integrity and Management.
New PICS Guidance on Data Integrity and Management. from GMP EDUCATION : Not for Profit Organization
]]> 5044 6 https://cdn.slidesharecdn.com/ss_thumbnails/newpicsguidanceondataintegrityandmanagement-160823140333-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 New WHO Guidance on CS Validation /slideshow/new-who-guidance-on-cs-validation/64093993 newwhoguidanceoncsvalidation-160717064541
This presentation gives a summary of the New WHO guidance on Computer System Validation.]]>
This presentation gives a summary of the New WHO guidance on Computer System Validation.]]> Sun, 17 Jul 2016 06:45:41 GMT /slideshow/new-who-guidance-on-cs-validation/64093993 shettyuc@slideshare.net(shettyuc) New WHO Guidance on CS Validation shettyuc This presentation gives a summary of the New WHO guidance on Computer System Validation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceoncsvalidation-160717064541-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of the New WHO guidance on Computer System Validation.
New WHO Guidance on CS Validation from GMP EDUCATION : Not for Profit Organization
]]> 18637 10 https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceoncsvalidation-160717064541-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 New WHO Guidance on Process Validation /slideshow/new-who-guidance-on-process-validation/63731903 newwhoguidanceonprocessvalidations-160705075959
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification. These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures. The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document: Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1) Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems Appendix 3: Cleaning validation - consensus to retain Appendix 4: Analytical method validation - update in process Appendix 5: Validation of computerized systems - update in process Appendix 6: Qualification of systems and equipment - update in process Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015 Comments on this draft document are due by July 12, 2016. A presentation on this guidance is given below: Presentation on New WHO Guidance on Validations ]]>
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification. These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures. The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document: Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1) Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems Appendix 3: Cleaning validation - consensus to retain Appendix 4: Analytical method validation - update in process Appendix 5: Validation of computerized systems - update in process Appendix 6: Qualification of systems and equipment - update in process Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015 Comments on this draft document are due by July 12, 2016. A presentation on this guidance is given below: Presentation on New WHO Guidance on Validations ]]> Tue, 05 Jul 2016 07:59:59 GMT /slideshow/new-who-guidance-on-process-validation/63731903 shettyuc@slideshare.net(shettyuc) New WHO Guidance on Process Validation shettyuc WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification. These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures. The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document: Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1) Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems Appendix 3: Cleaning validation - consensus to retain Appendix 4: Analytical method validation - update in process Appendix 5: Validation of computerized systems - update in process Appendix 6: Qualification of systems and equipment - update in process Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015 Comments on this draft document are due by July 12, 2016. A presentation on this guidance is given below: Presentation on New WHO Guidance on Validations <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceonprocessvalidations-160705075959-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> WHO has recently issued draft document titled &quot;Guidelines on Validation&quot;. These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification. These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures. The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document: Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1) Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems Appendix 3: Cleaning validation - consensus to retain Appendix 4: Analytical method validation - update in process Appendix 5: Validation of computerized systems - update in process Appendix 6: Qualification of systems and equipment - update in process Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015 Comments on this draft document are due by July 12, 2016. A presentation on this guidance is given below: Presentation on New WHO Guidance on Validations
New WHO Guidance on Process Validation from GMP EDUCATION : Not for Profit Organization
]]> 9362 18 https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceonprocessvalidations-160705075959-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 ASTM Standard E 2500 for Commissioning and Qualifications /slideshow/astm-standard-e-2500-for-commissioning-and-qualifications/61460630 astme2500standardforcandq-160428123021
This presentation summarizes the use of ASTM Standard E 2500 for Commissioning and Qualifications of Manufacturing Systems.]]>
This presentation summarizes the use of ASTM Standard E 2500 for Commissioning and Qualifications of Manufacturing Systems.]]> Thu, 28 Apr 2016 12:30:21 GMT /slideshow/astm-standard-e-2500-for-commissioning-and-qualifications/61460630 shettyuc@slideshare.net(shettyuc) ASTM Standard E 2500 for Commissioning and Qualifications shettyuc This presentation summarizes the use of ASTM Standard E 2500 for Commissioning and Qualifications of Manufacturing Systems. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/astme2500standardforcandq-160428123021-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation summarizes the use of ASTM Standard E 2500 for Commissioning and Qualifications of Manufacturing Systems.
ASTM Standard E 2500 for Commissioning and Qualifications from GMP EDUCATION : Not for Profit Organization
]]> 6790 7 https://cdn.slidesharecdn.com/ss_thumbnails/astme2500standardforcandq-160428123021-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 US FDA - EU Process Validation : Determination of Number of PPQ Batches /slideshow/ud-fda-eu-process-validation-dermination-of-number-of-ppq-batches/61448531 derminationofnumberofppqbatches-160428063700
This presentation is based on a discussion paper published by ISPE and deals with Statistical approaches for determining the number of PPQ batches. ]]>
This presentation is based on a discussion paper published by ISPE and deals with Statistical approaches for determining the number of PPQ batches. ]]> Thu, 28 Apr 2016 06:36:59 GMT /slideshow/ud-fda-eu-process-validation-dermination-of-number-of-ppq-batches/61448531 shettyuc@slideshare.net(shettyuc) US FDA - EU Process Validation : Determination of Number of PPQ Batches shettyuc This presentation is based on a discussion paper published by ISPE and deals with Statistical approaches for determining the number of PPQ batches. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/derminationofnumberofppqbatches-160428063700-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation is based on a discussion paper published by ISPE and deals with Statistical approaches for determining the number of PPQ batches.
US FDA - EU Process Validation : Determination of Number of PPQ Batches from GMP EDUCATION : Not for Profit Organization
]]> 3507 8 https://cdn.slidesharecdn.com/ss_thumbnails/derminationofnumberofppqbatches-160428063700-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Presentation on US FDA Data Integrity Guidance. /slideshow/presentation-on-us-fda-data-integrity-guidnace/60942794 usfdadataintegrityguidance-160415061307
This presentation gives a summary of US FDA guidance on Data Integrity.]]>
This presentation gives a summary of US FDA guidance on Data Integrity.]]> Fri, 15 Apr 2016 06:13:07 GMT /slideshow/presentation-on-us-fda-data-integrity-guidnace/60942794 shettyuc@slideshare.net(shettyuc) Presentation on US FDA Data Integrity Guidance. shettyuc This presentation gives a summary of US FDA guidance on Data Integrity. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/usfdadataintegrityguidance-160415061307-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of US FDA guidance on Data Integrity.
Presentation on US FDA Data Integrity Guidance. from GMP EDUCATION : Not for Profit Organization
]]> 35760 46 https://cdn.slidesharecdn.com/ss_thumbnails/usfdadataintegrityguidance-160415061307-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Quality Risk Assessmsnt for Environmental Monitoring /slideshow/quality-risk-assessmsnt-for-environmental-monitoring/60396466 riskassessmsntforenvironmentalmonitoring-160403005442
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations. Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring. This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring. ]]>
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations. Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring. This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring. ]]> Sun, 03 Apr 2016 00:54:42 GMT /slideshow/quality-risk-assessmsnt-for-environmental-monitoring/60396466 shettyuc@slideshare.net(shettyuc) Quality Risk Assessmsnt for Environmental Monitoring shettyuc Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations. Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring. This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmsntforenvironmentalmonitoring-160403005442-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations. Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring. This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
Quality Risk Assessmsnt for Environmental Monitoring from GMP EDUCATION : Not for Profit Organization
]]> 10962 18 https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmsntforenvironmentalmonitoring-160403005442-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Understanding and Preventing Clean Room Contamination /slideshow/understanding-and-preventing-clean-room-contamination/60334153 understandingandpreventingcleanroomcontamination-160401100123
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinm端ller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R. Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. Drug Regulations is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. ]]>
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinm端ller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R. Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. Drug Regulations is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. ]]> Fri, 01 Apr 2016 10:01:23 GMT /slideshow/understanding-and-preventing-clean-room-contamination/60334153 shettyuc@slideshare.net(shettyuc) Understanding and Preventing Clean Room Contamination shettyuc This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinm端ller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R. Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. Drug Regulations is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/understandingandpreventingcleanroomcontamination-160401100123-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinm端ller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R. Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. Drug Regulations is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
Understanding and Preventing Clean Room Contamination from GMP EDUCATION : Not for Profit Organization
]]> 6880 17 https://cdn.slidesharecdn.com/ss_thumbnails/understandingandpreventingcleanroomcontamination-160401100123-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Process Validation of Legacy Products /slideshow/process-validation-of-legacy-products/60280088 processvalidationoflegacyproducts-160331113727
This presentation gives guidance on process validation of Legacy products based on the FDA and EMA requirements.]]>
This presentation gives guidance on process validation of Legacy products based on the FDA and EMA requirements.]]> Thu, 31 Mar 2016 11:37:27 GMT /slideshow/process-validation-of-legacy-products/60280088 shettyuc@slideshare.net(shettyuc) Process Validation of Legacy Products shettyuc This presentation gives guidance on process validation of Legacy products based on the FDA and EMA requirements. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/processvalidationoflegacyproducts-160331113727-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives guidance on process validation of Legacy products based on the FDA and EMA requirements.
Process Validation of Legacy Products from GMP EDUCATION : Not for Profit Organization
]]> 2977 7 https://cdn.slidesharecdn.com/ss_thumbnails/processvalidationoflegacyproducts-160331113727-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 WHO Guidance on Technology Transfers /slideshow/who-guidance-on-technology-transfers/59938644 whoguidanceontechnologytransfers-160323143738
This presentation gives a summary of WHO guidance on Technology Transfers.]]>
This presentation gives a summary of WHO guidance on Technology Transfers.]]> Wed, 23 Mar 2016 14:37:38 GMT /slideshow/who-guidance-on-technology-transfers/59938644 shettyuc@slideshare.net(shettyuc) WHO Guidance on Technology Transfers shettyuc This presentation gives a summary of WHO guidance on Technology Transfers. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/whoguidanceontechnologytransfers-160323143738-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of WHO guidance on Technology Transfers.
WHO Guidance on Technology Transfers from GMP EDUCATION : Not for Profit Organization
]]> 79481 20 https://cdn.slidesharecdn.com/ss_thumbnails/whoguidanceontechnologytransfers-160323143738-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Who Guidelines for Preparing SMF /slideshow/who-guidelines-for-preparing-smf/59004495 whoguidelinesforpreparingsmf-160303061213
This presentation gives a summary of WHO requirements for preparing a Site Master File : SMF.]]>
This presentation gives a summary of WHO requirements for preparing a Site Master File : SMF.]]> Thu, 03 Mar 2016 06:12:13 GMT /slideshow/who-guidelines-for-preparing-smf/59004495 shettyuc@slideshare.net(shettyuc) Who Guidelines for Preparing SMF shettyuc This presentation gives a summary of WHO requirements for preparing a Site Master File : SMF. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/whoguidelinesforpreparingsmf-160303061213-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives a summary of WHO requirements for preparing a Site Master File : SMF.
Who Guidelines for Preparing SMF from GMP EDUCATION : Not for Profit Organization
]]> 2859 11 https://cdn.slidesharecdn.com/ss_thumbnails/whoguidelinesforpreparingsmf-160303061213-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Validation of Microbiological Methods /slideshow/validation-of-microbiological-methods/57050153 validationofmicrobiologicalmethods-160114115232
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and Key criteria that may be applicable for assessment. ]]>
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and Key criteria that may be applicable for assessment. ]]> Thu, 14 Jan 2016 11:52:32 GMT /slideshow/validation-of-microbiological-methods/57050153 shettyuc@slideshare.net(shettyuc) Validation of Microbiological Methods shettyuc This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and Key criteria that may be applicable for assessment. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/validationofmicrobiologicalmethods-160114115232-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and Key criteria that may be applicable for assessment.
Validation of Microbiological Methods from GMP EDUCATION : Not for Profit Organization
]]> 27299 22 https://cdn.slidesharecdn.com/ss_thumbnails/validationofmicrobiologicalmethods-160114115232-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-shettyuc-48x48.jpg?cb=1640613967 "GMP Education" is a not for profit organization established with an objective to provide latest information to the Pharmaceutical Industry professional in fields like Regulations, cGMP , GDP, GCP, Drug Development, Mergers and acquisitions. " Drug Regulations" provides daily update with latest happenings in the Pharmaceutical World to its members without any charge. To obtain daily updates join the LINKEDIN group " Drug Regulations". www.gmp.education https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmentforelementalimpurities-160907135737-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/risk-assessment-for-control-of-elemental-impurities/65781397 Risk Assessment for Co... https://cdn.slidesharecdn.com/ss_thumbnails/pharmaceuticalqualitysystem-160906084750-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/pharmaceutical-quality-system/65728642 Pharmaceutical Quality... https://cdn.slidesharecdn.com/ss_thumbnails/newwhoguidanceonanalyticalmethodvalidation-160904181526-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/new-who-guidance-on-analytical-method-validation/65678840 New WHO Guidance on An...