Improve Your FDA Compliance

In recent articles, we have explored a comprehensive FDA compliance strategy (Preplanning, Professional Conduct, Post-Inspection Actions) designed to provide the best long-term compliance results without high remediation costs. In this article, we will discuss perhaps the best way to improve your FDA compliance…Effective Training. 

The Regulations
The FDA regulation governing training is found in 21 CFR 211.25(a), Personnel Qualifications: 

Each person engaged in the manufacture, processing, packing or holding of a drug product shall have education, training and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practices (cGMP) (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practices shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.

In other words, the FDA regulations require drug manufacturing firms to conduct two types of training: 

     ■ Function-Specific Training (also required by DOT) 

     ■ Current Good Manufacturing Practices Training (including your SOPs). 

In the 2003 Draft Guidance, the FDA clarifies: 

FDA recommends that cGMP training not be conducted in one massive training session. Rather, it should be presented in smaller, more manageable sessions held throughout the year, or at a minimum be held once a year. We recommend that the specific type of training received or covered, the time and the attendance at each session be documented, and records of the training be maintained.

The lack of documented cGMP training is one of the most often cited violations we observe. Moreover, training can be one of the easiest compliance items to correct. In addition, effective training can actually improve your operations by reducing errors and increasing efficiency. 

The FDA does not specify the format of the training. You can conduct group meetings or individual training sessions. You can view videos, review SOPs, study CGMP, attend seminars and perform hands-on training experiences. However, in order to be compliant, you must document the training. Simply, if the training is not documented, the FDA will assume it was not performed.

Tools for GAWDA Members
1. Tech Support: All GAWDA members have access to FDA technical support. Feel free to contact me with any medical gas training question.

2. GAWDA Training Record: The GAWDA Safety Committee developed a personnel training record, which is well suited for documenting your FDA compliance training. Download a copy of this document. I can also provide you with a copy of this document.

3. GAWDA University: Contact Robbie Roberts ( for enrollment information in GAWDA University. This online resource offers a wide variety of training topics for members.

4. Online Seminars: cGMP seminars are offered monthly and cover a wide variety of subjects.

5. Professional Compliance Seminars: Four DOT/OSHA/FDA seminars are held around the country in 2011.

6. GAWDA Medical Gas Program: Members who license the medical gas program have free monthly access to the GAWDA Medical Gas Roundtable, free pre-recorded cGMP training sessions, free Driver CGMP training, free Operator CGMP training and more.

When to Train
You can expect that the FDA investigator will verify that your personnel are trained. We recommend conducting the cGMP and function-specific training before the audit rather than after the audit. If you would like more training information, contact me at the phone number or email address below.

Gases and Welding Distributors Association

Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and