This is a past event.
Complying with FDA's Good Documentation Practices [It Didn't Happen]
Overview:
In a pharmaceutical or medical device environment documentation needs to
meet certain requirements to ensure product quality and product safety.
Why should you Attend:
As the FDA and TGA say "If it isn't written down, then it didn't happen". To
meet industry standards, it is critical that all documentation follows GDP
when it affects:
GMP /GLP /GCP processes
Material or product identity, quality, purity, strength and safety
Areas Covered in the Session:
Document Approval
Handwritten Entries
Copies of Documents
Document Maintenance
Document Modification
Warning Letters for GDocP
