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

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?

Fortunately, there are measures you can take to increase the likelihood these employees will stay with your organization. A well-designed Onboarding Program is an integral part of your company’s culture. It not only promotes new hire retention but also can have new hires contributing independently to the business more quickly.

• 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 

Compliance considerations, your quality culture, and work culture are all important points of focus. Additionally, where do employee “onboarding” end and real “job training” start? Your onboarding effort is critical in so many other ways too, as it represents your only opportunity at a first impression, and allows you to shape early motivation for your new employees. Although many hiring managers and other supervisory personnel struggles with onboarding, there are simple steps you can take to ensure a successful and compliant program. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.

This course will be of benefit to anyone responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. 

• Training department management
• Human Resource personnel
• Training professionals
• Instructional designers
• Supervisory management of operational departments
• QA/QC personnel
• Manufacturing managers/supervisors
• Pharmaceutical and cGMP auditors
• Compliance officers
• Validation specialists, scientists, engineers
• Medical/technical writers
• Consultants/service providers
• Engineering and design controls teams
• General/corporate counsel

Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 17 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's 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 workplan for Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.