Management of Service Providers

5/5
48
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Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

The relevance of a fool-proof service provider recruitment program by pharmaceutical companies is that it provides a barrier that allows only materials and services of acceptable quality to be used in the manufacturing process. This course shows the importance of following a uniform recruitment process which includes the evaluation of the service provider’s reputation in the market and the quality of the materials and services they provide. To achieve GMP, it is also necessary for a credible monitoring process to be put in place to ensure that the quality provided is consistent. It is always in the best interest of the consumers and the company’s image that the teams involved in the recruitment process be made up of qualified individuals.

 

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

Curriculum

 

Lesson 1: Who is a Service Provider?

 

  • The Key Steps for Management of Service Providers

 

Lesson 2: Identification

 

Lesson 3: Evaluation and Assessment

 

Lesson 4: Qualification

 

  • Key Factors to Be Evaluated While Approving a Service Provider
  • Guidelines to Establish a Supplier Qualification Program to Source GxP Relevant Materials and Services of Standard and Consistent Quality
  • Assurance of Supply
  • Quality and Regulatory Compliance
  • Technical/Innovation
  • Responsiveness & Communication
  • Different Types of Service Providers
  • Reported Cases Where Mandatory Steps Are Not Followed

 

Lesson 5: Audits

 

Lesson 6: Agreements

 

Conclusion

 

References

 

Glossary

 

Quiz Questions and Feedback

Author:

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Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job

Reviews:

5/5
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