Good Manufacturing Practice (GMP) Course

CME Credits: 1 Credit (as suggested by the California Medical Association)

Duration: 1 Hour

Description: This course will introduce you to the concepts and requirements necessary for compliance with Good Manufacturing Practice (GMP) for pharmaceuticals and biopharmaceuticals. This course will prepare you to establish and document a system of GMP controls required to manufacture drug products in the United States, the European Union, Japan, and in many parts of the world.

COURSE OUTLINE

Introduction

1. Course Information

2. Interface Tour

3. Course Overview History and Purpose of GMP

4. Objectives

5. Pre-Test

6. Pharmaceutical and Biopharmaceutical Manufacturing

7. FDA History

8. Regulatory Inspection Process

9. CGMP

10. Progress Check

Areas of GMP

11. Progress Check

12. Pre-Test

13. Quality Control Unit

14. Personnel Controls

15. Facility and Equipment Controls

16. Production and Process Controls

17. Validation

18. Laboratory and Materials Controls

19. Batch Release

20. Deviation and Complaint Reporting

21. Progress Check Documentation

22. Objectives

23. Pre-Test

24. Research and Development Documentation

25. Supplier Qualification Documentation

26. Batch Production Records

27. Quality System Records

28. Records Retention

29. Records During an Inspection

30. Progress Check Conclusion

31. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

> List the basic elements of a GMP manufacturing process.

> Describe the purpose of GMPs and their historical roots.

> List important milestones in the development of GMP requirements.

> Describe GMP.

> Identify areas of a facility inspected by the FDA and other regulatory authorities during a GMP inspection.

> List GMP requirements for the following:

- The Quality Control Unit (QA and QC)

- Management and Personnel o Facilities and Equipment

- Laboratories and Materials Controls

- Production and Process Controls

- Batch Release

- Customer Complaints, Deviations and Quality Investigations

> List data-recording rules that support good manufacturing practice.

> Describe the role that version control and document change control have on production and process controls.

> Describe the elements of a change control system.

> Describe the elements of a deviation reporting and investigation system.

Each Online Training Course or Professional Designation Program listed below comes complete with;

> 24 hour access to the course for 90 days,

> a printable PDF file including the notes to the course,

> a test used to measure your understanding of the material provided in the course, and

> a Certificate of Completion once you have passed a course, or;

> a Certificate of Professional Designation if you are enrolling in a Professional Designation program
Unit 4 of 6 courses
Price: $175.00 / GBP96.25