Data integrity and good documentation practices (GDP) are essential in providing evidence of a safe and effective product. Learn what the key elements of good documentation practices and data integrity are, how to apply them, and how to proactively ensure your system is compliant.
By the end of the course, participants will be able to:
- Describe FDA Regulations for Good Documentation Practices (GDP)
- Perform GDP
- Describe FDA Guidance for Data Integrity
- Apply Data Integrity
- Apply Risk Management, Investigation, and CAPA to Data Integrity Concerns
Who Should Attend:
Anyone who works in a regulated industry
No prerequisites required. Overview of FDA Regulations and Quality Systems Overview or relevant experience are highly recommended.
Cost: Half-day class
Location: Oregon Bio Virtual Classroom