Chemistry, Manufacturing and Controls (CMC) Training
Receive a Credit toward the Diploma program in Professional Regulatory Affairs
Abstract
The objective of this course is to provide a strong understanding of the importance and underlying principles for CMC requirements from the regulatory perspective. Participants will gain an understanding of the CMC portion of a Common Technical Document (CTD) which is the format that regulatory submissions in Canada and the EU must be filed.
Course Outline
This course provides an in-depth analysis of the CMC portion of a Common Technical Document. The following specific topics will be addressed in detail:
- Role of CMC in drug development
- Nomenclature and characterization of drug substance
- Analytical methods and validation
- Manufacturing, in-process controls and process validation
- Developing drug substance and drug product specifications
- Stability, stability-indicating tests and how much change is acceptable
- Regulatory expectations for product characterization
- Drug Master Files
- Structure, content and components relating to CMC section of a regulatory submission
Who Should Attend
This one-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Regulatory Affairs
- Quality Assurance
- Product Submission
- Training
- Consultants
- Clinical Research
- Documentation and Technical Writing
- Project Management
- Product Development
- Others who interact together to launch a product
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
