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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.

Details

Date:
August 24, 2021
Time:
12:00 pm - 1:00 pm
Cost:
Free
Event Categories:
,

Venue

Online
Oregon