CMC & Manufacturing Training Courses

• Trainer Expertise — All our instructors are industry veterans with hands-on experience across small biotechs, large pharmaceutical companies, contract manufacturers, and global regulatory agencies.
• Practical Focus — Case studies, interactive workshops, and real-world project examples ensure you can translate complex CMC theory into practical solutions for your development programmes.
• Global Regulatory Coverage — Courses include up-to-date content on EMA, FDA, ICH and other global regulatory expectations for CMC submissions, manufacturing controls, and quality standards.
• Post-Learning Support — Gain access to reinforcement materials, detailed reference guides, and ongoing updates to help you retain knowledge and confidently apply it to your work.
• Flexible Delivery Formats — Learn in the way that suits you best: live online, hybrid, classroom, or on-demand modules, available for both individuals and teams.

In our CMC training portfolio, topics include:

• Analytical method development & validation (ICH, USP, compendial)
• Process development, scale-up & tech transfer
• Formulation, stability, and shelf-life testing
• Quality control, process validation & assay qualification
• Control strategy, risk assessment, and data integrity
• Regulatory submissions: CMC sections in CTD / BLA / NDA / IMP dossiers
• Manufacturing of biologics / cell & gene / viral vectors
• GMP manufacturing, facility design, process analytics

Our training courses are ideal for:

• Analytical & formulation scientists
• Process development / manufacturing engineers
• Quality control / assurance professionals
• Regulatory affairs staff managing CMC documentation
• Biopharma / cell & gene therapy / viral vector organisations
• Startups needing CMC roadmap guidance

CMC Training for Biologics, Small Molecules & Advanced Therapies

Whether you’re in small molecule drug development or cell & gene therapy, the CMC (Chemistry, Manufacturing & Controls) backbone is critical. Our courses bridge scientific principles with regulatory expectations.

Scale-up, Process Transfer & Tech Transfer Strategies

We cover all phases: from lab scale to pilot to commercial manufacturing, including tech transfer best practices, process validation, control strategies, and equipment qualification.

Analytical Method Validation, Stability & Control Strategy

Learn how to design, validate, transfer, and maintain analytical methods; develop stability protocols; and implement robust control strategies within your quality system.

Regulatory Requirements & CMC Submissions

Deep dive into CMC sections of regulatory dossiers (Modules 2 & 3 of CTD/BLA), regulatory expectations for CMC in FDA / EMA / ICH guidelines, and dossier preparation best practices.

Benefits of Our Training for Your Team

Equip your team with the technical depth and compliance mindset to reduce delays, audit findings, and regulatory risk. Our training helps engineers, scientists and regulatory professionals speak the same language and drive alignment across functions.