FDA Cites Training Failures - Apr 2, 2008

Training is an important element of GMP, and the FDA is not reluctant to cite a company for failures in this area. Here’s an actual citation from a Warning Letter issued in late February to a Medical Device manufacturer.

Failure to establish procedures for identifying training needs and for ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25(b). Your firm's training of operators was inadequate in that:

• You have no document control of your operator training packet that consists of multiple, separate, non-sequentially numbered training documents.
• Your operator training protocol is not linked to your written training procedures and has no document control to include management approval prior to implementation.
• You do not have documentation of reviewing and approving an operator's training and testing records and results prior to the employee being released to receive medical alarm calls.

Read the entire Warning Letter issued to Philips Lifeline, Inc. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

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