Achieving and
Maintaining 21 CFR Part 11 Compliance
Seminar Agenda
AM 9:00 – noon
v Introduction
– Session Agenda and Goals
– History & Rationale of the Rule
- Other Regulatory Initiatives
v 21 CFR Part 11 Rule Content
v Cryptography & Digital Signature Concepts
v Part 11 Compliance Process
– Process Introduction
– System Inventory
PM 1:00 – 5:00
v Part 11 Compliance Process (continued)
– GAP Analysis Exercise
– Remediation Planning
– Options
– Enabling Technologies
v Staying Current
– 483s & Warning Letters
– Industry & Agency Actions
– Resources
v Wrap-up
