FDA s New Draft Guidance on Data Integrity for CGMP Compliance 2016 is a webinar that covers topics such as:
- Definitions
- Overview of the draft Data Integrity Guidance
- FDA`s Current Narrow Scope and Application of 21 CFR Part 11 (ER and ES)
- What is CGMP Data? Company Usage?
- Lab Data Issues
- FDA expectations for a Company`s Data Integrity Assurance Systems - Access, e-records / e-signatures
- Potential Problem Areas and their Resolution
FDA s New Draft Guidance on Data Integrity for CGMP Compliance 2016 is intended for:
- QA
- Senior management in Drugs, Devices, Biologics, Combination products, Dietary Supplements, and Veterinary
- Engineering
- RA
- Production
- R&D
- Consultants; others tasked with product, process, validations, CGMP responsibilities
- Operations
- Useful for members of AQC, RAPS, AAMI, etc
