Seminar September 9, 2009

GMP Training Documentation: Steps to Prove Compliance

Event Detail
Cathy L. Burgess
September 9, 2009

Cathy Burgess presented this audioconference sponsored by Thompson Interactive.   The FDA has made clear that, for drugs and devices, GMP training must be documented:

"Each manufacturer shall establish procedures for identifying training needs ... Training shall be documented."

21 CFR 820.25 "Managers are expected to establish training programs that include ... documentation of training and/or re-training."
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

Sounds simple enough. And yet, warning letters continue to cite GMP training documentation violations, such as this letter from September 2008:

"failed to comply with Section 1.4.1 of its training procedure to implement and document new hire training activities for employees engaged in the production of drug products."

And this from May 2009:

"You do not have records documenting your employee has the necessary education, background, training, or experience."

This program provided guidance for companies on how to get their training documentation in compliance, and what is needed to keep it there. Cathy described what good and bad documentation looks like, and provided steps companies could take to get their training records into line before their next inspection.  The following topics were covered during Cathy's presentation.

    • More than just the sign-in sheet—the checklist of GMP training documents investigators want to see. 
    • Do you have to prove employees have simply been trained, or that they have learned what was presented? 
    •  Organizing training documentation—do you keep them in your HR files, your audit files, or somewhere else? 
    •  How often should you be updating your training documentation? 
    •  Do outside training, audio conferences or classes count toward GMP training? How should they be recorded and verified?
    • What if your employees have received more training than has been documented? Can you update the records based on recollection and research, or must they be retrained?
          Meet The Speakers
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          Phone: 212.210.1222
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