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