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Methods and Reference Standards for CMC Analytical Studies

Course summary
4 weeks
Online courses
Professional Training

Course description

Methods and Reference Standards for CMC Analytical Studies

The second course in the online biopharmaceutical and biosimilar CMC analytical series follows on from the first course on regulatory challenges. This course focuses on analytical method lifecycles as well as characterization and control of product reference standards. 

This course has been designed to provide you with the technical know-how, so you understand and select the right method verification, qualification and validation. During the 4 weeks, you will review the major life cycle elements and deliverables for biopharmaceutical/biosimilar products.

In addition, you will learn about the quality, regulatory and monitoring aspects of different types product reference standards and critical assay reagents.

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.

  • Examine analytical QbD and how it differs from traditional strategies
  • Define the difference between method verification, qualification and validation
  • Discover the common challenges of analytical methods and how to overcome them
  • Examine best practice when methods change
  • Explore the various biotech reference standards
  • Assess the various critical assay reagents
  • Learn best quality practices when managing a reference standard and critical assay reagent program

Training Course Content

  • Module 1 - 3 : Technical Considerations in CMC Analytical Method Lifecycles: Qualification, Validation, Verification, Transfer, Bridging
  • Module 4 - 6 : Characterization and Control of Biological Product Reference Standards and Critical Assay Reagents

Why choose PTI

On average, delegates of their online academies said: 

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85% had applied content during the course to their role

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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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