GMP 0: Good Manufacturing Practice, Overview

Duration: 2 Hours

Certificate of Completion:

Provided immediately upon successful completion.

GMP 0: Good Manufacturing Practice, Overview 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.

Accreditation: GeneEd designates this educational activity for a maximum of 2 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.

GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.

In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.

GMP 0: Good Manufacturing Practice, Overview

OUTLINEINTRODUCTION

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

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

OBJECTIVES: Students completing this course, GMP 0: Good Manufacturing Practice, Overview, 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.

About GeneEd's Online Training:

* GeneEd Online Training Courses are high-quality, Flash driven, learning tools including voiceovers and dynamically engaging graphic animations.

* This GeneEd Online Training Course is accessible for 90 days via the Internet, and a Certificate of Completion is accessible once requirements are filled.

* GeneEd Online Training Courses have an instructional design which encourages knowledge retention and long term recollection.

* GeneEd Online Training Courses are developed for healthcare professionals (nurses and doctors), clinical researchers, and for patient education.

* To access your GeneEd Online Training Course, your username, password and login URL will be provided to you shortly after ordering.

Unit 4 of 6 courses
Price: $175.00 / GBP115.50