Current Good Manufacturing Practices (cGMP) Certified Professional (GMPCP)
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 Three):
- Good Manufacturing Practices (cGMP)™
- cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices™
- Validation of Computer Systems™
- Root Cause Analysis of Failures & Deviations – Developing an Effective CAPA Strategy™
- Process Validation for Drugs and Biologics™
- Effective Risk-Based Applications of Drug cGMPs and Validation Requirements of Cosmetics and OTC Drug Products™
Elective Courses (Choose One):
- Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products™
- FDA Inspections: What Regulators Expect and How to Prepare™
- Stability Programs for Product Shelf Life - From Development to Approval™
- Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries™
- Writing Effective Standard Operating Procedures and Other Process Documents™
- Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries™
- Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products™
- Pharmaceutical, Biopharmaceutical, and Biologics Quality Control Laboratories: A Regulatory Compliance Primer™
- Pharmaceutical Production Batch Record Review™
- Active Pharmaceutical Ingredient (API) and Drug Product Specifications™
- QA/QC Strategy for Biologics and Biopharmaceuticals™
- NEW! Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices™
To find out more about our medical device certification programs, visit our Certification 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, contact us at +1-610-688-1708, toll-free at 855-752-9320 or contact us.
You may also be interested in viewing a complete list of medical device training courses.