Good Documentation Practice for GxP Environments 2016

Topics

• Why document?
• FDA 101: who is the FDA, regulations, guidances, documentation and industry
• What documentation does FDA look for during an inspection?
• What needs to be documented?
• Examples and exercises for good documentation
• What do the GMP, GCP, and GLP regulations and guidances say about documentation?
• Summary/ Q&A

Who should Attend

Attendees from:

• R&D
• GxP personnel involved with GxP Documentation
• Quality
• Production
• Regulatory