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Regulatory and Compliance Requirements for CMC Analytical Studies

Course summary
4 weeks
Online courses
Professional Training

Course description

Regulatory and Compliance Requirements for CMC Analytical Studies

The course will provide you with regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4 weeks you will learn what studies are needed and, crucially, when they must be completed to minimise development delays affecting your protein products (breakthrough or biosimilar).

In addition, you will gain best practice as you transition from R&D laboratory analytics to GxP requirements gaining an appreciation of the data required and the risks involved.

Suitability - Who should attend?

This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.

Outcome / Qualification etc.

  • Discover the global regulatory requirements for CMC biologics
  • Learn what CMC data sets are required for all protein products, including biosimilars
  • Examine when CMC analytical studies must be conducted during development
  • Understand the CMC timelines for biosimilar and biopharmaceutical breakthrough products
  • Learn best practice for taking your R&D laboratory work to GxP standards
  • Explore the GxP requirements for analytical CMC biologics
  • Discover the common R&D quality and documentation issues with biopharmaceutical and biosimilar products

Training Course Content

  • Module 1 - 3 : Regulatory Basis of CMC Analytical Requirements for Biological Products: Doing the Right Things at the Right Times
  • Module 4 - 6 : Dossier R&D Data versus GxP Data: Analytical Lab Quality Practices from R&D to GxP

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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Average rating 5

Based on 1 reviews

International Sales Manager
Good introductory training.
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