Procedures for design validation must address risk analysis where appropriate.
Adulteration, misbranding and design validation cause a problem for one company.
Is your risk management process rock solid?
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.
If you haven’t made the connection yet, you’re in trouble.
The proverbial rubber meets the road when the actual execution of test protocols commences. In this edition of Devine Guidance , Dr. D will continue with his dissection of 21 CFR, Part 820; Section 820.30, subsection f (design verification) and subsection g (design validation).