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.
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.
This workshop covers the following topics:
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 ValidationDevelop proficiency in selecting and validating analytical methods, as well as characterizing drug substances and products to meet regulatory standards.
Expertise in Manufacturing and Process ValidationLearn 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 TestingAcquire 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.
AAPS
Instructor
Andy Tallevi is a Formulation/Process Consultant for Keller Consulting in Mississauga, Ontario, Canada, with 28 years of experience primarily in the pharmaceutical industry. He assists clients in the pharmaceutical and chemical industries with formulation and process issues and is an instructor at AAPS.
Andy spent a year with Health Canada, reviewing and evaluating generic submissions and gaining insights into regulatory requirements. He has a deep understanding of pharmaceutical development, GMP requirements, and has supported audits by Health Canada and the FDA.
Previously, Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline in Canada for 18 years, specializing in solid oral dosage forms and overseeing the manufacture of clinical supplies of NCEs. He holds a US patent for assessing pharmaceutical powder flow.
Andy also worked for Unilever, developing products in the health, beauty, and detergent industries. He graduated from the University of Toronto with a B.Sc. in Chemistry.
