GMP: Good Manufacturing Practice Overview
This course introduces the concepts and requirements necessary for compliance with Good Manufacturing Practice (GMP) for pharmaceuticals and biopharmaceuticals. The course prepares learners to establish and document a system of GMP controls required to manufacture drug products in the United States, the European Union, Japan, and many other parts of the world.
After completing this course, participants 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
- Identify areas of a facility inspected by the FDA and other regulatory authorities during a GMP inspection
- List GMP requirements for the Quality Control Unit (QA and QC), Management and Personnel, Facilities and Equipment, and Laboratories and Materials Controls
- List GMP requirements for Production and Process Controls, Batch Release, Customer Complaints, and Deviations and Quality Investigations
- List data-recording rules that support GMP
- 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
Our e-courses are only available for group and corporate-wide licenses. Pricing is based on the estimated number of users. Please contact us to learn more about incorporating the GxP and Regulatory Series into your corporate training program. We can also develop custom training solutions to meet your specific training needs.