PSG-CASTL Biomanufacturing Regulatory Compliance Course

Level

Advanced

Prerequisites:

Participants should have prior experience in biopharmaceutical manufacturing. Basic knowledge of Good Manufacturing Practices (GMP), working in a regulated environment, and quality systems is required. Please contact us if you are uncertain whether you meet these prerequisites.

Format

On-site, practical, including essential theory

Duration

2 days

Cost

Pharmaceutical Sciences Group (PSG) members, please contact info@psg.ca for a 10% discount code.

Overview

This intensive, two-day, in-person course, co-delivered with the Pharmaceutical Sciences Group (PSG), participant with the knowledge and confidence to navigate regulated biopharmaceutical environments. Through an exploration of GMP principles and the full product lifecycle—from early development to commercialization—participants gain the skills needed to ensure product quality, safeguard patient safety, and address critical quality and validation challenges.

Why It’s Essential

Designed for intermediate- to advanced-level professionals looking to strengthen their GMP expertise within the regulated life sciences sector, this course provides a comprehensive exploration of biomanufacturing fundamentals and regulatory expectations. It connects each stage of the product lifecycle—from early research to commercialization—to the production environment and manufacturing unit operations for biological therapeutics.

Learning Objectives

This course strengthens proficiency in current GMP standards and best practices within Canada’s evolving biomanufacturing landscape. Through a blend of classroom and laboratory training over three interactive modules, participants gain an in-depth understanding of Canadian Life Sciences regulations and biotherapeutic product life cycle requirements, enabling them to apply proactive compliance and quality approaches within their organizations thanks to:

• Enhanced knowledge of biopharmaceutical manufacturing in a regulated environment

• An understanding of how product life cycle stages influence all aspects of biomanufacturing and directly impact product quality and safety

• An understanding that quality and validation issues are essential to successful manufacturing

Who Should Attend

Anyone interested in deepening their understanding of biomanufacturing operations and bio/pharmaceutical professionals looking to expand their knowledge of biotherapeutics, including:

• Operators, supervisors, and managers 

• Operations support personnel (e.g., quality assurance, compliance, quality control, microbiology, validation department personnel)

• Scientists and engineers working in biopharmaceutical development

• Suppliers to the industry

Participants who successfully complete a theoretical assessment will receive a certificate of completion.