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.
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