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

Why Should You Attend:

Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.

Learning Objectives:

The objective of the course is to enable attendees to:

• Define the onboarding process in the context of regulatory compliance
• Interact with Human Resources to create a coordinated onboarding strategy that covers both their requirements and quality requirements
• Differentiate the training requirements for full-time employees and contractors, and articulate the rationale behind treating these individuals the same or differently in a given situation
• Distinguish training requirements for new employees vs. employees transferring internally
• Prioritize training items to insure compliance
• Reduce the learning curve for new or transferred employees

In addition, the course addresses the following commonly asked questions regarding the onboarding process:

• Are contractors treated the same as long-term employees?
• Where does 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?

Areas Covered in the Webinar:

• 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 Will Benefit:

This course will be of benefit to anyone who is responsible for onboarding new or transferred pharmaceutical employees, including:

• Pharmaceutical managers with direct reports; Human Resources professionals, especially those that train new employees or supervise HR trainers; Trainer, Training Manager (particularly in the Quality organization)

Michael Esposito
Principal, TrainReach Consulting, LLC

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.

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