Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection
Why Should You Attend:
Can you show me how you manage your computer systems in compliance with 21CFR Part 11?
This presentation will describe a process which has prepared several companies to answer this question from FDA inspectors accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff.
Attendees will learn how to prepare and present a concise and comprehensive presentation to regulatory inspectors. Preparation and knowing in advance the expectations and required deliverables for a successful inspection is critical to your pharmaceutical, medical device, biotechnology or software company. Case studies will be presented showing the outcomes for three inspections at companies following this methodology.
Areas Covered in the seminar:
- 21CFR Part 11 Requirements.
- Regulatory Inspections of Computer Systems.
- Required Policies and Procedures.
- Training.
- Performing a Comprehensive Inventory: Team Effort.
- System Inventory Assessment – Preliminary Risk Assessment.
- Compliance Assessment – Compliance Risk Analysis, Gap Analysis and Corrective Actions.
- Remediation Plans and Schedules.
- Presenting to the Inspector.
- Case Studies : Federal and State Regulatory Inspections.
