Overview:
Find out why GDP is essential to proving your product is safe and effective, and its relation to FDA regulations. For anyone who works in a regulated industry.
Area of focus may include:
- 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
About the Presenter:
Cheryl Bondurant, CAI Principal Consultant, is a professional with 41 years of experience working in FDA and ISO regulated environments. She has implemented effective compliant quality systems for medical devices, biologics, in-vitro diagnostics and electronics.
Cheryl is an instructor of FDA regulations and ISO standards and implementation for Quality Systems for Medical Devices and Current Good Manufacturing Practices for Finished Pharmaceuticals.
