Workshop Details

Dates

October 10, 2024

Time

9:00 pm – 5:00 pm

Cost

CAD $645.00 + HST

Location

Online

Deadline

October 3, 2024

Workshop Overview

The objective of this workshop is to provide participants with a comprehensive understanding of the importance and underlying principles of Chemistry, Manufacturing, and Controls (CMC) requirements from a regulatory perspective. Attendees will gain in-depth knowledge of the CMC section of the Common Technical Document (CTD), the required format for regulatory submissions in Canada and the EU. This workshop will equip participants with the skills needed to effectively compile and present CMC data, ensuring compliance with regulatory standards and facilitating successful submissions.

Who Should Attend​

This workshop is tailored for professionals involved in regulatory affairs, quality assurance, and product development within the pharmaceutical and biopharmaceutical industries. It is particularly beneficial for those responsible for compiling and submitting CMC data, including regulatory submission specialists, technical writers, project managers, and quality control personnel. Additionally, consultants and other stakeholders engaged in the preparation of regulatory submissions will find this workshop invaluable for understanding and meeting CMC requirements.

Workshop Outline

This workshop covers the following topics:

  • The Role of CMC in Drug Development
  • Nomenclature and Characterization of Drug Substances
  • Analytical Methods and Validation Techniques
  • Manufacturing Processes, In-Process Controls, and Process Validation
  • Developing Specifications for Drug Substances and Drug Products
  • Stability Testing, Stability-Indicating Methods, and Managing Acceptable Changes
  • Regulatory Expectations for Product Characterization
  • Understanding and Utilizing Drug Master Files
  • Structure, Content, and Key Components of the CMC Section in Regulatory Submissions

Learning Outcomes

Comprehensive Understanding of CMC in Drug Development

Gain a thorough understanding of the role and importance of Chemistry, Manufacturing, and Controls (CMC) in the drug development process, ensuring regulatory compliance and product quality.

Mastery of Analytical Methods and Validation

Develop proficiency in selecting and validating analytical methods, as well as characterizing drug substances and products to meet regulatory standards.

Expertise in Manufacturing and Process Validation

Learn best practices for manufacturing processes, in-process controls, and process validation, including the development of robust drug product specifications.

Proficient in Regulatory Submissions and Stability Testing

Acquire skills in preparing the CMC section of regulatory submissions, understanding the structure and components, and conducting stability testing to determine acceptable changes and ensure product integrity.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

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Donald Perez

AAPS

Instructor

Coming Soon