Introduction

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 different in a given situation
• 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

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

• 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 is geared toward the pharmaceutical industry, particularly for anyone who is responsible for managing or delivering training in a GMP environment, and HR employees who interact frequently with the GMP training organization to coordinate onboarding. The aim of the course is to provide practical information, which has already been used on the job effectively and suggest similar actions that learners can apply to their job situations quickly. 

Learning Objectives

• 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

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. 

Who Will Benefit

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