Webinar on Training Requirements under FDA's Quality System Regulation

Description :

Training requirements can make or break a firm's compliance program. A weak training program becomes a weak link in a firm's ability to make a product that conforms to FDA requirements.

An effective training program should enhance and ensure a firm's regulatory program and play a major role in supporting a firm's product, operations and the human factors environment. During an inspection, the FDA investigator may think:

Do these manufacturing employees know what they are doing?

Is the CEO's secretary qualified to manage the firm's Quality Assurance program?

Rejected products can be traced back to at least three employees X. Were they trained or retrained?

The complaint file indicates product A is associated with a lot of serious injuries and recalls. Do the employees have the knowledge, training or skills to design, make or evaluate product A?

This firm is mired in recalls. Does the firm have the technical knowledge and skill to identify the root cause and take corrective and preventive action?

Employee Z is making a lot of mistakes. Was Z trained or retrained and tested? Is there on-the-job-training supervision?

Areas Covered in the Session :

You should understand how the QSR personnel training requirements directly or indirectly affect a firm's conformance to all QSR requirements. The adequacy of training can bear on the quality of the products placed into the market. If your firm is involved with ongoing recalls or repetitive adverse events reports, then ask yourself whether employee training is related to a root cause?

How do you associate management responsibilities with employee training? Is it an orphaned consideration? Employee training affects FDA's evaluation of a firm's organizational management, not just the training itself as on-the-job training, academic background, technical knowledge or skills. If an employee training program is not robust, does that mean that the management does not really care in the first place? That is a fair question for the FDA investigator to ask.

Who Will Benefit:

Manufacturing Senior Managers and Supervisors

Quality Control Managers

Quality Assurance Managers and Auditors

Complaint and Recall Managers

Product Design Engineers

Personnel Department Hiring Manager

Consultants