GMP Training Documentation: Steps to Prove Compliance

Presented by Cathy Burgess

Recorded On: Thursday, July 22, 2010

Duration: 90 minutes

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RECORDING HIGHLIGHTS:

The FDA has made it clear that, for drugs and devices, GMP training must be documented: “Each manufacturer shall establish procedures for identifying training needs ... Training shall be documented.”(from 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 December 2009:

“Training records do not document training on [the] procedure…The employee’s training records do not document training on how to review quality control and quality assurance issues.”

And this from January 2010:

“Your firm failed to provide documentation establishing that your lab analyst, who performs QC laboratory analyses, including microbial tests, was trained and qualified to perform laboratory tests.”

Find out if your training documentation is in compliance, and what you need to do to make sure you stay in compliance. In this 90-minute audio conference, GMP expert attorney Cathy Burgess will describe what good and bad documentation looks like, and will provide steps companies can take to get their training records corrected before their next inspection.

Learning Points:

GMP training documents investigators want to see—attendees will be provided with a detailed checklist.
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?
Does 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?

Attendees Who Will Benefit From This Audio Conference Include:

Regulatory affairs
Corporate and general counsel
Inspection and audit staff
Training managers
Documentation and SOP managers
Executive management
Risk management professionals

YOUR EXPERT(S):

Cathy Burgess

is a counsel in Crowell & Moring’s Health Care Group. She advises clients on FDA regulatory matters affecting prescription and OTC drugs, biologics, medical devices and cosmetics. Her practice primarily focuses on compliance, especially related to good manufacturing practices and quality systems. She advises clients on compliance programs, adequacy of SOPs, investigation reports, inspection management, responding to Form FDA 483s and Warning Letters and recalls. She also conducts internal investigations and special audits related to FDA compliance.

Cathy also provides advice on legislative matters affecting FDA regulated entities. She assists in development of legislative strategies, assists clients with testimony, prepares staff for interviews with committee staff and provides advice on pending legislation.

Prior to joining the firm, Cathy was associate general counsel for the American Red Cross, where she served as regulatory counsel for the organization. One of her primary responsibilities was providing legal assistance and strategic advice to Red Cross management and the Board of Governors' Audit Committee on matters related to the Red Cross Amended Consent Decree. In 1992, Cathy was the number two person on the defense team in United States v. Barr Laboratories, Inc., the leading case on current good manufacturing practices for pharmaceutical companies.

Cathy earned her J.D. from the Catholic University of America’s Columbus School of Law.