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:

  • Two full days of presentations, panel discussions, and networking
  • 15 industry experts share their knowledge and lessons learned
  • Full coverage of best practices in CSV, Data Integrity, and Process Validation
  • Hear FDA's latest expectations for PV
  • Learn how Artificial Intelligence is changing PV

Highlights of CSV, Data Integrity & Process Validation 2021

*Meeting FDA Regulatory Requirements for Process Validation

~Mariza Jafary, Consumer Safety Officer, Office of Regulatory Affairs, FDA

*Artificial Intelligence (AI) in Process Validation

~Mayank Bansal, Director of Product Development, AbbVie

*Examining FDA's Data Integrity Guidance

~Raul Soto, Senior Principal Software Engineer, Johnson & Johnson

*Right-Sized Sampling & Statistics for the PV Lifecycle

~Katherine Giacoletti, Partner, Synolo Stats, LLC

*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

"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