Healthcare 2021 - Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

Overview:
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
Although FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work environment.