Management of Service Providers

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