The webinar explores what the GxP regulations and guidance's say about Good Documentation Practice. Examples of both good and poor documentation are given and exercises demonstrate both good and poor practices.
Why You Should Attend: In today's strict regulatory environment it is more important than ever for companies and individuals to understand and practice good documentation to comply with FDA regulatory requirements. This webinar will cover Good Documentation Practice for GxP environments. Understand what needs to be documented, what FDA looks for in documentation, relevant regulations for documentation, and related guidance's.
Areas Covered in the Session:
FDA 101: who is the FDA, regulations, guidance's, documentation and industry
What needs to be documented?
What documentation does FDA look for during an inspection?
What do the GMP, GCP, and GLP regulations and guidance's say about documentation?
Examples and exercises for good documentation
John R. Godshalk,