The latest observations from GMP Trends Report #1148 revealed a series of significant compliance gaps across several pharmaceutical and medical device firms, particularly in areas of management oversight and employee training.
The following spotlight 483 raises the critical question: does the President of your company fully understand their job responsibilities, especially in compliance and quality management?
Specifically, your firm failed to define training requirements for its … employees. There are no training requirements defined for positions in your procedure SOP … Additionally, a job description was not developed for the firm’s President.
Ensuring that top executives, including the President, are thoroughly trained in their responsibilities is not merely a regulatory checkbox. An executive’s knowledge—or lack thereof—affects every level of an organization.
Without clear training protocols, Presidents and other senior managers may fail to implement crucial quality controls, contributing to deficiencies that impact product safety, regulatory compliance, and company reputation.
FDA expects documented job descriptions for senior roles and executives, including the firm’s President. 21 CFR 820.25(b) underscores the importance of defined training procedures to ensure that all personnel are equipped to handle their responsibilities effectively.
The regulation mandates that manufacturers “establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.” Notably, this requirement applies to all employees, including executives, as their understanding of quality and compliance impacts the entire operation.
For quality-focused leaders in the pharmaceutical and medical device industries, compliance should start from the top. Executives need to be fully aware of both their responsibilities and the potential risks associated with inadequate training and oversight. Joining GMP Trends would directly assist your firm in avoiding this 483.
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