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 frameworks 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.Often there are questions regarding how to translate these requirements into the day-to-day operations of the company. Of particular interest are the different perspectives of onboarding from Human Resources and Quality Assurance (particularly Training), each of which has its own priorities. Managers, likewise, are eager to have their employees qualified to perform their job functions as efficiently as possible because of pressure to keep pace with the business, and will communicate their expectations to these two organizations. A successful onboarding strategy will combine the inputs of all these stakeholders and help create a consistent and well-understood process for the company.Learning ObjectivesDefine the onboarding process in the context of complianceInteract with Human Resources to create a coordinated onboarding strategyDifferentiate the training requirements for full-time employees and contractorsDistinguish training requirements for new employees vs. employees transferring internallyPrioritize training items to ensure complianceReduce the learning curve for new or transferred employeesAreas CoveredFAQs for employee onboardingManagement’s expectations for new employeesHR onboardingQuality’s role in the onboarding processGMP training requirementsHandling full-time employees vs. contractors and other temporary personnelBenchmarks for training and competencyWho Should AttendIn a Pharmaceutical Environment, either at Corporate Offices or at Manufacturing Facilities or Distribution Centers: Managers with Direct ReportsHuman Resources ProfessionalsQuality Assurance and Training DepartmentsWhy Should You AttendOnboarding in a GMP environment leads to some questions and confusion. Are contractors treated the same as long-term employees? Where do GMP Training end and HR training begin? When can employees begin working? How differently should new and transferred employees be treated in the onboarding process? This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.