Overview
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 framework 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
to 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 have 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.
Why should you Attend
Onboarding in a GMP environment leads to some questions and
confusion. 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?
This course will address the issues that accompany onboarding new or
transferred employees and enable you to navigate them successfully.
By the end of this webinar, you should be able to:
- Define the onboarding process in the context of compliance
- Learn to interact with Human Resources to create a coordinated onboarding strategy
Differentiate the training requirements for full-time employees and
contractors, and for new employees vs. employees transferring internally
Prioritize training items to both ensure compliance and reduce the
learning curve for new or transferred employees.
Areas Covered in the Session
- 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
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
Speaker Profile
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 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 workplan for McNeil and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.