FDA’s New Draft Guidance on Data Integrity for CGMP Compliance 2016
25 Oct 2016
Webinar
Key Topics
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
Who should Attend
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
Past Events
FDA’s New Draft Guidance on Data Integrity for CGMP Compliance 2016 - 25 Oct 2016, Webinar (62793)
FDA’s New Draft Guidance on Data Integrity for CGMP Compliance 2026
Important
Please, check "FDA’s New Draft Guidance on Data Integrity for CGMP Compliance" official website for possible changes, before making any traveling arrangements
