FDA Regulatory Training for Product Safety, Quality, and Efficacy

The requirements for regulatory training focused on GMP are divided into two aspects — the types of employees who need to be trained and the components of the training program.

Types of employees who need regulatory training include:

• Employees across various departments such as manufacturing, warehousing, or packaging
• Supervisors involved in the development, manufacturing, or drug storage to ensure safety and quality
• Personnel who are qualified to manufacture and supervise the process

FDA is very specific about who is trained and what they are trained for. Some of the guidelines for the FDA training include:

• Employees who are part of production or drug storage must have relevant experience and training.
• The training must be for the exact process along with detailed information on the CFR requirement and the procedures associated with their role.
• All the training-related information must happen at regular intervals and must be delivered by qualified personnel.
• Employees must be trained for various corporate training requirements such as orientation, Quality Systems, safety, job-specific training, and re-training information.

The FDA training program is overseen by the senior management. To meet FDA requirements, manufacturers must prepare and conduct detailed training programs that will sustain the quality of the products and the safety of the employees.

The FDA regulatory training plan must include all the training information, such as CSR regulation and other job function-specific procedures. An FDA inspection includes an evaluation of the training documents. FDA regulatory training program will focus on:

• A clear evaluation of the organization’s training needs, including training schedules, and all relevant information for every function.