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

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. This chemistry, manufacturing and controls training and certification covers requirements for regulatory submissions, as well as, 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.

Certification Program FAQs:

Chemistry 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.

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Skill Level CORE COURSE LIST
Advanced Specifications for APIs & Pharmaceutical Drug Products
Advanced Analytical Method Validation: Biologics & Biopharmaceuticals
Foundational CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars™
Foundational CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
Foundational Comprehensive Overview of FDA Regulatory Compliance for Drugs & Biotech Products™
Foundational European Regulatory Procedures - EMA and National Requirements™
Foundational European Union Regulatory Issues – New Product Development
Foundational Good Manufacturing Practices Training | GMP Course
Advanced Implementing an FDA Compliant Stability Program
Foundational Introduction to Medical Combination Products
Foundational Laboratory Equipment Validation and Qualification
Advanced Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy
Foundational Preparation of FDA Submissions and Communicating with the FDA™
Foundational Preparing the CMC Section for NDAs-INDs-CTDs™
Foundational Process Validation for Drugs and Biologics™
Foundational Quality Assurance/Quality Control for Biologics and Biopharmaceuticals™
Foundational The Drug Development Process from Concept to Market™

If you have 10 or more employees that would benefit from CMC pharmaceutical 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.

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