CSV, Data Integrity & Process Validation Virtual Summit, 2021
January 20-21, Online Eastern Standard Time













Are you compliant with FDA requirements for CSV, Data Integrity & Process Validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes through a drug product's cycle. That is why you cannot afford to miss Pharma Ed's CSV, Data Integrity & Process Validation Virtual Summit. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.
Why Attend:
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Highlights of CSV, Data Integrity & Process Validation 2021
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*Meeting FDA Regulatory Requirements for Process Validation
~Mariza Jafary, Consumer Safety Officer, Office of Regulatory Affairs, FDA |
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*Artificial Intelligence (AI) in Process Validation ~Mayank Bansal, Director of Product Development, AbbVie |
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*Examining FDA's Data Integrity Guidance ~Raul Soto, Senior Principal Software Engineer, Johnson & Johnson |
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*Right-Sized Sampling & Statistics for the PV Lifecycle ~Katherine Giacoletti, Partner, Synolo Stats, LLC |
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*A Case Study in FDA Inspection of CSVs-Key Takeaways & Lessons Learned ~Mike Fitch, Independent QA CSV Consultant at Takeda |
What People Are Saying about Pharma Ed's Virtual Conferences
"Great to be a part of the virtual summit! Wonderful talks throughout! Please count me in for future events." ~ Senior Director, J&J "This was my first virtual conference and it was much better than I expected. The willingness of the participants to stick around and chat in the off times was really nice also. Thanks for organizing and making this happen." ~ Independent Consultant, Mycroft Medical "I had a great experience with the online platform this year. . . . I think this was very well done and made for two very informative shows." ~ Vice President, Jordi Labs |
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"This has been a great meeting." ~ Research Materials Engineer, FDA "I have thoroughly enjoyed the E&L summit. Thanks so much for organizing it." ~ Analytical Chemist, FDA "Congratulations with the event! It is really unbelievable how well this is organized, it is like you have always organized virtual events all your life!" ~ Scientific Director, Nelson Labs |
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