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Chemistry, Manufacturing and Controls Workshop

December 6, 2019 @ 9:00 am - 5:00 pm

Chemistry, Manufacturing and Controls Workshop

Receive a Credit toward the Diploma program in Professional Regulatory Affairs

Register online

Dates Available

August 13, 2021

Time

9:00 am - 5:00 pm

Cost

CAD $585 + HST

Location

Online

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.

Details

Date:
December 6, 2019
Time:
9:00 am - 5:00 pm

Venue

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

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