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Understanding Computer System Validation requirements as per revised Schedule M
Revised Schedule M: Critical Requirements for Manufacture of Biological Products
Revised Schedule M: Critical Requirements for Manufacture of Biological Products
This Webinar will cover key aspects of the CSV requirements and best practices for documentation as the Revised Schedule M and relevant WHO guidance.
Revised Schedule M: Critical Requirements for Manufacture of Biological Products
Revised Schedule M: Critical Requirements for Manufacture of Biological Products
Revised Schedule M: Critical Requirements for Manufacture of Biological Products
The Webinar will provide the details about New and Critical Requirements for Manufacture of Biological Products, for the manufacture, control, and testing of biological products.
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Revised Schedule M: Optimised pharmaceutical water systems
Revised Schedule M: Optimised pharmaceutical water systems
Revised Schedule M: Optimised pharmaceutical water systems
The webinar will refer to different regulatory guidance’s and standards, such as WHO TRS Annex 3 and EU Annex 1, water monographs from the Indian pharmacopeia as well as other pharmacopeias and the revised schedule M
New FDA Guidance for Topical Ophthalmic Drug Products
Revised Schedule M: Optimised pharmaceutical water systems
Revised Schedule M: Optimised pharmaceutical water systems
Former FDA compliance officials Chris Fanelli and Jay Jariwala will share their analysis of this FDA guidance, and provide their views on what ophthalmic drug manufacturers could expect with respect to FDA inspection and regulatory enforcement activity.
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Implication of the revised Schedule M & its compliance to Sterile Filtration, Single Use System & Sterility Testing
With introduction of pharmaceutical quality system emphasizing on GMP and QRM principle, the revised schedule M recommends using closed systems for high-risk manufacturing such as sterile pharmaceutical preparations, biological products etc. There are sections on Single-use systems & Sterility testing which will be dealt in detail. The newly added section – Part IV, Specific Requirements for Manufacture of Biological Products highlights the importance of a robust contamination control strategy (CCS), implementation of single use systems can be instrumental to developing a comprehensive CCS. This webinar will address use of single use system for sterile products and regulatory expectations when implementing single use systems for closed processing.
Knowledge is more powerful when it’s shared
A Complimentary Platform to share knowledge
Knowledge is much more powerful when it’s shared.
We encourage knowledge sharing and have provided Pharma Professionals a platform to share knowledge. We pride upon the knowledge-sharing culture which allows us to tap into subject matter experts across the globe. When these experts share their experiences, they allow others to skip the trial and error phase and get right to productivity.
One of the best things about this platform to share knowledge is that we can learn from mistakes and make sure we don’t repeat them. When experts share what hasn’t worked it prevents somebody else from making the same errors.
But when one finds something that works and has worked better than anything else before, one needs to share that knowledge with rest of the community. When people are learning from each other and have a platform to share their knowledge, that builds a sense of community. Especially when the takeaways from colleagues help people to do their job better.
We are pleased that we could serve Pharmaceutical Professionals during these difficult and challenging times through our “Complimentary Webinars” Pharma Best Practices Webinars. Since March 2020, we hosted around 112 webinars each featuring a leading subject matter expert from all around the world who were members of several NON PROFIT ORGANISATIONS. The presentations covered topics which were critical and relevant in pharmaceutical manufacturing, Quality and Technology.
We are very pleased that with these 100+ sessions we reached more than 25,000 professionals who attended our sessions live and more than 1,50,000 or so who watched recorded sessions.
We take this opportunity to thank you for YOUR TRUST AND FAITH IN US and ALSO THANK YOU FOR SUPPORTING our Philosophy of Sharing Knowledge on a Complimentary Platform for the benefit of community at large.
We invite you to join us in sharing Knowledge for the benefit of Pharma Community
The information collected when you register for a webinar will not be shared with any organization and will not be used for any commercial purposes. We follow the provisions of Indian Information Technology Act to protect your data.
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