With the recent publication of FDA’s CSA Draft Guidance, there is much discussion surrounding Computer Software Assurance implementation, critical thinking, and risk assessments. In addition, the new draft guidance has affected another FDA regulatory hot button – 21 CFR Part 11 (Electronic Records and Signatures).
This training uncovers the impact of FDA’s new Computer Software Assurance guidance on 21 CFR Part 11 and the controversy surrounding these areas. This will be in the next big task for FDA and global regulatory agencies are already tackling the challenges (PIC/s and EU’s Annex 11).
Speakers:
Stephen Cook
VP, Validation Quality & Compliance, Compliance Group
Topic: Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11
Time: 10:30 AM – 11:30 AM on 16th May 2023
Daniel Walter
Policy Analyst, CDRH, U.S. FDA
Topic: Understanding the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11
Time: 10:30 AM – 11:30 AM on 16th May 2023
Calvin Kim
Head of Quality Systems and Validation, Samsung Biologics
Topic: Lean Validation Case Study – Build a Modern, Risk-based CSV Program Aligning with CSA and Part 11
Time: 8:30 AM – 9:15 AM on 17th May 2023
Meher Muttanapalli
Senior Manager, Software Quality Engineering & CSV, Robotics & Digital Solutions, Johnson & Johnson
Topic: Implement a CSA Training Program and Measure Success
Time: 12:45 PM – 1:30 PM on 17th May 2023
Stephen Cook
VP, Validation Quality & Compliance, Compliance Group
Topic: Review Top Takeaways for Immediate Impact
Time: 03:15 PM – 4:00 PM on 17th May 2023
Save 5% on your ticket when you register with code: CG5