Chemistry, Manufacturing and Controls Workshop

Receive a Credit toward the Diploma program in Professional Regulatory Affairs

Register online     |     Download Registration Form (PDF)

Dates Available

December 6, 2019

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $585.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

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

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course

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.