The FDA defines expertise as a combination of experience, education, and training. In a regulatory inspection how do you justify the training approach for the training system and for a role/task, etc.?-The ability to prove to the FDA that a company has a process, approach and ability to execute training is key to meeting the Part 211 - Current Good Manufacturing practice for finished pharmaceuticals - Subpart B - Organizational and Personnel, Sec. 211.25 Personnel qualification standard.-Demonstrating how training is created, delivered, tracked and sustained is important to ensure that the process developed to manufacture drug products is reliable and reproducible to ensure safety and efficacy of drug products for consumers.
At the end of this webinar, participants will be able to:
- Understand Employee Qualification from the regulatory perspective - Define Curriculum and Qualification - Discuss Training Effectiveness - Discuss how to apply risk to manage training assignments - Discuss Metrics and training completion before conducting GMP assignments - Understand how Learning Management Systems (LMS) can be used to manage employee curriculum requirements - Assign Learning Plans that detail the list of components assigned to a leaner based on learning need - Explain an Exemption Process and how to document an employee’s equivalent experience - Identify Training Due Dates
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