Good Documentation 2021 - Good Documentation Practices Live Webinar

Good Documentation is necessary to demonstrate we work in a compliant manner. We will discuss some of the principles that lead to good or bad documentation, the regulations that are driving why we need good documentation
The goal of documentation should be to ensure compliance. However, failures in documentation and procedures represent more than half of the top citations by FDA. FDA is telling us we just don’t get it. To attempt to remedy this finding, this presentation will discuss the purpose of good documentation
General Principles and Key Definitions
Regulations (FDA and EU)
Documentation - Instructions
Speaker:
Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 20 years as a consultant to biopharma, pharma and device industries.