Don’t Let Poor Training Records Derail Your FDA Compliance

21 CFR 211.25 specifies employee training and education must have “sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.” 

The most recent report from GMP Trends highlights how a pharmaceutical company was cited by the FDA for lacking GMP-training records for several employees involved in manufacturing.

“…. GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them. 

Specifically, your firm’s SOP …, “Employee Training”, is deficient that it does not require training in current good manufacturing practices on a continuing basis and with sufficient frequency to assure that employees stay familiar with cGMP requirements applicable to them. 

Your firm was unable to provide the most recent cGMP training for your facility’s Head of Maintenance, in the last 5 years.”

This pharmaceutical company’s exact case is severe, highlighting the need to require consistent training sessions relating to cGMP training and education. The GMP Trends Report is an excellent work-flow to ensure you do not receive this 483-observation. 

Utilize GMP Trends as a component of your employee training and education program. Schedule a demo today. 

Keeping detailed, accurate training records is critical for demonstrating employees are prepared and educated through continuous training programs. It is not enough to just train employees once – there needs to be a comprehensive and consistent training program that is properly documented.

To enhance your employee training program, visit FDA’s Training and Education program. There is also a continuing education program featuring FDA experts, focused on the safe use of drugs and medical products.

With access to GMP Trends yearly subscription, read analysis of FDA 483-Observations and empower employees’ daily work with actionable information. Schedule a demo of the GMP Trends platform today. 

To view more observations pertaining to training, refer to the following GMP Trends® Issues: 1129, 1128, and 1113.

Train and Empower your employees with GMP Trends. Schedule a demo today.