(GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™

The FDA's regulations on Current Good Manufacturing Practices (cGMP) affect many different phases of pharmaceutical, biologic and biopharmaceutical development. As a result, CfPIE has developed a certification program to meet the educational needs of those responsible for compliance with this complex regulation. This track is for any individual accountable for any aspect of cGMP compliance. Our industry experts have developed the core and elective components of this program to give participants in-depth knowledge of cGMP regulations - from clinical development through post-approval drug and biotech product manufacture. Each cGMP training course is designed to present and explain cGMP mandates, as well as to provide comprehensive analysis and instruction on how to best comply.

Core Courses:

Choose any three below:

  1. Active Pharmaceutical Ingredient (API) & Drug Product Specifications – From Clinical Development to Market Approval
  2. Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
  3. Best Practices for an Effective Cleaning Validation Program
  4. Cleanroom Microbiology for the Non-Microbiologist
  5. GMPs for OTC and Cosmetic Products – US and Global Requirements
  6. Good Manufacturing Practices (cGMP)
  7. Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment
  8. Lyophilization Technology – Practical Application of the Scientific Principles
  9. Process Validation for Drugs and Biologics
  10. Pharmaceutical Root Cause Analysis of Failures & Deviations – Developing an Effective CAPA Strategy
  11. Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
  12. Pharmaceutical Production Batch Record Review
  13. Understanding Sterilization Methods for Products and Devices
  14. Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval
  15. Validation of Computer Systems
  16. Water Purification Systems for Regulated Industries - Design, Chemistry and Validation

Elective Courses:

Choose a fourth course from the list above or one from any of our other classroom courses.

To find out more about our medical device certification programs, visit our FAQs page.

If you have 10 or more employees that would benefit from certification, we can offer complete program tracks on-site at your facility. For more information, call us at 1-610-648-7550 or contact us.

You may also be interested in viewing a complete list of medical device training courses.