(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.

Certification Requirements:

  1. Choose 3 Core Courses from any of the courses listed below.
  2. Choose 1 Elective Course from any of our other classroom courses.

For more about our certification programs: FAQs.

Skill Level
Course Name
Advanced Active Pharmaceutical Ingredient (API) & Drug Product Specifications – From Clinical Development to Market Approval
Advanced Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Foundational Best Practices for an Effective Cleaning Validation Program
Cleanroom Microbiology for the Non-Microbiologist
Foundational CGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
GMPs for OTC and Cosmetic Products – US and Global Requirements
Foundational Good Manufacturing Practices (cGMP)
Foundational Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment
Foundational Lyophilization Technology – Practical Application of the Scientific Principles
Foundational Process Validation for Drugs and Biologics
Advanced Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
Foundational Pharmaceutical Production Batch Record Review
Foundational Pharmaceutical Root Cause Analysis of Failures & Deviations – Developing an Effective CAPA Strategy
Foundational Understanding Sterilization Methods for Products and Devices
Advanced Stability Programs for Determining Product Shelf Life – From Clinical Development to Market Approval
Foundational Validation of Computer Systems
Foundational Water Purification Systems for Regulated Industries - Design, Chemistry and Validation

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.

Pharma and Biotech Courses Medical Device Courses Skin/Cosmetics Courses