FDA’s New Draft Guidance on Data Integrity for CGMP Compliance 2016
25 Oct 2016
Webinar
Description
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FDA’s New Draft Guidance on Data Integrity for CGMP Compliance 2016 - 25 Oct 2016, Webinar (62793)
Important
Please, check "FDA’s New Draft Guidance on Data Integrity for CGMP Compliance" official website for possible changes, before making any traveling arrangements
