Onboarding in a GMP Environment: Best Practices for Foundational Employee Success
Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree work plan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
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 their 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.
- Define the onboarding process in the context of compliance
- Interact with Human Resources to create a coordinated onboarding strategy
- Differentiate the training requirements for full-time employees and contractors
- Distinguish training requirements for new employees vs. employees transferring internally
- Prioritize training items to ensure compliance
- Reduce the learning curve for new or transferred employees
- FAQs for employee onboarding
- Management’s expectations for new employees
- HR onboarding
- Quality’s role in the onboarding process
- GMP training requirements
- Handling full-time employees vs. contractors and other temporary personnel
- Benchmarks for training and competency
Who Should Attend
In a Pharmaceutical Environment, either at Corporate Offices or at Manufacturing Facilities or Distribution Centers:
- Managers with Direct Reports
- Human Resources Professionals
- Quality Assurance and Training Departments
Why Should Attend
Onboarding 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.