Minimizing Your Risks under Annex 11 and Part 11: What FDA and Global Regulators Now Expect

Minimizing Your Risks under Annex 11 and Part 11: What FDA and Global Regulators Now Expect
Everywhere you turn, inspector scrutiny of data integrity at manufacturing, clinical and laboratory sites is increasing. The FDA's highly-touted Part 11 "add-on" inspections are uncovering a host of industry mistakes and misconceptions. Coupled with the agency's recruitment of more tech-savvy inspectors, the amount of 483 observations and warning letters focused on poor systems management is bound to rise. Abroad, you face even more requirements under the EU's new Annex 11, including auditing service providers, qualifying your IT infrastructure, and managing lifecycle risks.
Attendees will learn:
• 5 key targets of FDA and global investigators when they review your computerized systems
• Lessons from recent and landmark warning letters
• What's on the horizon: Part 11 revision? FDA adoption of Annex 11 provisions?
Martin Browning, President and Co-Founder, EduQuest; Former Special Assistant to FDA's Associate Commissioner for Regulatory Affairs and Vice Chair of the FDA's Electronic Records and Signatures Working Group, which drafted the original 21 CFR Part 11 regulation