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 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 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 has its 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 you 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.
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