Management of Service Providers

5/5
48
Management of Service Providers

Duration :

2

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

A fool-proof service provider recruitment program provides a barrier for only materials and services of acceptable quality in the manufacturing process.

This course shows the importance of following a uniform recruitment process. The process should include the evaluation of the service provider’s reputation in the market and the quality of the materials or services they provide.

A credible monitoring process ensures that the quality provided is consistent. Hence, your recruitment team should include qualified professionals. Consequently, the company’s image will be preserved and the consumers interests protected.

 

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

 

Evaluation

 

Glossary

Author:

Ellena Jefferson
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
48
USD: United States (US) dollar ($) ^

$60

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00

$60.00

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