White Paper: In a regulatory inspection how do you justify training?
How do you justify training in your organization? The FDA defines expertise as a combination of experience, education, and training. The ability to prove to the FDA that a company has a process, approach, and ability to execute training is key to meeting the 21CFR Part 211 or Part 820 – Current Good Manufacturing practice for finished pharmaceuticals – Subpart B – Organizational and Personnel, Sec. 211.25 Personnel qualification standard or for Medical Devices in Section 820.25, Personnel. Demonstrating how training is created, delivered, tracked and sustained is important to ensure that the process developed to manufacture drug products is reliable and reproducible to ensure safety and efficacy of drug products for consumers.
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