21 CFR Part11 Compliance
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained.Learning ObjectivesThe attendees will gain knowledge on:Company certificationRecords coveredAudit trailsOpen /closed system access rulesElectronic signaturesTraining requirementsWho Should AttendQuality ManagersQuality EngineersSmall Business OwnersGxP ProfessionalsConsultantsQuality VPsIT VPsEngineering personnelManagementWhy Should You AttendCompanies want to transition to electronic records but are afraid of compromising their quality system and receiving 483's at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints, the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation. This webinar will explain what all these means.
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained.
Learning Objectives
The attendees will gain knowledge on:
- Company certification
- Records covered
- Audit trails
- Open /closed system access rules
- Electronic signatures
- Training requirements
Who Should Attend
- Quality Managers
- Quality Engineers
- Small Business Owners
- GxP Professionals
- Consultants
- Quality VPs
- IT VPs
- Engineering personnel
- Management
Why Should You Attend
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483's at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints, the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation. This webinar will explain what all these means.
