Implementing the New FDA Data Integrity Guide - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Ludwig Huber

In the last couple of years FDA has increasingly observed CGMP violations involving data integrity lapses during CGMP inspections. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. For better understanding FDA's data integrity expectations the agency has published a draft guidance answering 18 questions related to data integrity for cGMP compliance.

The guidance also. clarifies the following terms as they relate to CGMP records: data integrity, metadata, audit trail, "static" and "dynamic" record formats, backup, and "systems" in "computer or related systems". Attendees of this seminar will be able to fully understand and implement the new FDA guidance and avoid regulatory actions related to data integrity

Areas Covered in the Session:
- Understand definitions and examples of data, raw data and met data
- Definition and examples of static and dynamic record formats
- The meaning of ALCOA and ALCOA+ components
- Review of electronic audit trail review: who, what, when and how
- Examples for 'computer or related systems' as defined by FDA
- What to do if the 'record' owner is also the system administrator?
- Controlling blank forms by the quality unit
- Procedure for using electronic records as a substitute for paper records
- Procedure for using paper records as a substitute for electronic records
- Procedure for using electronic signatures instead of handwritten signatures
- Definition and examples for system evaluation samples, system suitability standards and actual samples
- Handling internal integrity related tips, e.g., on data falsification
- Handling data integrity problems identified during internal audits and FDA inspections

For easy implementation, Attendees will receive:
- SOP: Integrity and Security of Electronic Data
- Checklist: Security and Integrity of Electronic Data
- Checklist: 21 CFR Part 11

Who Will Benefit:
- Everybody who creates, reviews and approves regulated electronic records
- Documentation Professionals
- QA/QC Managers and Personnel
- IT Professionals
- Analysts and Lab Managers
- Validation Specialists
- Consultants

Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website

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