The FDA's increased reliance on digital audits has fundamentally changed how validation teams need to prepare for scrutiny. But are your systems, documentation, and processes truly ready in this new environment?
How you can prepare your validation and quality documents for digital remote assessments.
Key differences between a physical inspection and a remote audit
Practical strategies to excel before, during, and after a remote assessment
Sr. Customer Success Engineer, Kneat
is a Six Sigma Black Belt with 10+ years’ experience in lyophilization development, technology transfer, and process development for pharma and life sciences companies. An author of multiple papers and whitepapers, Joe has also guest lectured at Purdue University, appeared on webinars and podcasts, and currently works with Kneat Solutions to bring digital validation to life sciences leaders
How digital validation reinforces operational readiness to build GMP compliance.
60 minutes
Michael Sweeney, Fintan Coady
Providing you with the foundation to fortify your compliance efforts in audits.
60 minutes
Kathianne Ross
Discover key strategies for preparing, navigating, and following up on inspections.
60 minutes
Joe Azzarella