(CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™

View Required Courses Certification FAQs

About the Chemistry, Manufacturing & Controls Certification Program

The Chemistry, Manufacturing & Controls (CMC) Certified Professional (CMCCP) Chemistry Certification program will benefit those involved in the development and manufacture of pharmaceuticals, as well as those preparing CMC documents for submission to regulatory agencies.

The CMC and CMCCP certification programs are available for individuals in the United States, Europe, Canada, Australia and Middle Eastern countries. Full List of Countries where we offer Pharma & Biotech and Medical Device Courses.

This chemistry, manufacturing and controls training and certification covers requirements for regulatory submissions, including how to adhere to Good Manufacturing Practices (GMP) throughout the product life-cycle. It offers a broad understanding of chemistry, manufacturing and controls topics and includes other specialized areas.

This track covers CMC certification information for both chemical drugs and biologicals. For specialized information related to biopharmaceuticals, see the Biopharmaceutical Development Certified Professional (BPCP) track.

"The trainings in the Certification Program are very informative and enhanced my industrial knowledge. The Program helped me just move to the next level in my career. Thank you for offering the helpful training certification programs”.

Maggie H., Assoc. Direct, Chem Development | Principia Biopharma

Contact a Training Advisor

We offer on-site pharmaceutical training and life science certification programs for organizations with 10 or more employees enrolling. Call us today at 1-610-648-7550 or Contact a Training Advisor.

Proceed To required Courses Certification FAQs

Chemistry Certification Requirements:

Choose 3 Core Courses from any of the courses listed below.
Choose 1 Elective Course (Can be a core course or any course listed at: Courses by Title)

Analytical Chemistry Principles for Pharmaceutical Scientists Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products Auditing and Qualifying Suppliers and Vendors Biostatistics for Non-Statisticians Change Control - GMP Requirements and FDA Enforcement CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products Computer System Validation Effective Document Management for Pharma, Biotech & Medical Device Ethics in Research - Values for Responsible Conduct of Research European Regulatory Procedures - EMA and National Requirements Good Manufacturing Practices Training | GMP Course Human Error Prevention (HEP) - Risk Factors and Strategies

Implementing an FDA Compliant Stability Program Introduction to Medical Combination Products Introduction to Statistical Analysis of Laboratory Data Introduction to Vaccines - CMC Regulatory and Quality Aspects Laboratory Equipment Validation and Qualification Oncology Drug Development Course - A Comprehensive Overview Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Preparation of FDA Submissions and Communicating with the FDA Preparing the CMC Section for NDAs/INDs/CTDs Process Validation for Drugs and Biologics Quality Assurance/Quality Control for Biologics and Biopharmaceuticals Specifications for APIs & Pharmaceutical Drug Products Technical Writing for Pharma, Biotech and Med Devices The Drug Development Process from Concept to Market Writing Effective SOP and Other Process Documents

Certification Program Discounts

If you have 10 or more employees that would benefit from this certification program, 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 & Biotech Courses

Medical Device Courses

Skin & Cosmetics Courses

Since 2006 CfPIE has