Training Requirements under FDA’s Quality System Regulation

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?
FDA regulates a medical device firm’s manufacturing operations under the Quality System Regulation (QSR). (21 CFR Part 820) The regulation includes requirements for personnel training within the context of the QSR management subsystem. During an inspection, the investigator will verify that employees know and understand their firm’s quality policy and check it against the firm’s written policy statement. Where on-the-job training, technical skills or special knowledge are required, the investigator may ask to see and review the supporting documentation for any relevant employee. Firms that conduct training programs are expected to have written procedures to explain the training program, how it is implemented, documented and verified, either through testing or job performance review. The history of the training program should reflect an employee’s duties and responsibilities throughout their employment.

FDA will look to see where training or the lack of effective training contributed to deviations from the QSR; complaints; recalls; rejected in-process goods or final product. Ultimately, the FDA investigator will use the training program findings as a reflection of whether or not a firm’s management makes provisions for the responsibilities, authorities and necessary resources to establish a compliant manufacturing operation. There are other related factors that influence the success or failure of an employee training program. FDA may not raise certain less objective factors, but the human factors associated with successful or failed training may affect someone’s motivation to care about training in the first place.

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

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

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