A Robust Approach to Validation in Compliance with 21 CFR, Part 820.75



Regardless or regulatory environment, United States or OUS, the validation of processes, which cannot be verified through inspection or test, is considered a salient requirement for medical device establishments. It is imperative that processes are capable of producing finished medical devices that are safe and effective in their intended use.

Failure to validate processes in accordance with §820.75 requirements is a frequently cited Form 483 observation in FDA warning letters. Device establishments either fail to validate their processes; or fail to validate their processes, with a high degree of assurance in accordance with established procedures. Remember, a manufacturing process that cannot be fully verified by subsequent inspection and testing is expected to be validated, to ensure the process continues to meet specifications as required by 21 CFR 820.75(a).

Areas to be Covered:

FDA requirements for validations
Understanding IQ, OQ, PQ, & PPQ
Scripting the validation protocol
Selecting confidence intervals
Training requirements
Equipment calibration requirements
Use of 3rd-party testing facilities to execute validations
Collection of validation data
The application of statistical analysis and documenting statistical rationale
Limit versus Challenge Conditions
Documenting deviations
Addressing validation failures
Documenting the requirement(s) for when to repeat validation

Who will Benefit:

A must attend webinar for all industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s validation studies. The staff who will benefit include:
Quality Professionals
Regulatory Professionals
Test Technicians
R & D Engineers
Manufacturing Engineers
Quality Engineers

Dr. Christopher J. Devine

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.


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