Analytical Methods in Development and Manufacture of Drugs and Biologics

Analytical Methods in Development and Manufacture of Drugs and Biologics is a seminar that covers topics such as:

  • Building quality in the product
  • Ensuring quality by the new paradigm of Quality by Design(QbD)
  • Regulatory Expectations and Requirements for the Methods during Product Development
  • Analytical Method Life Cycle during Product Development and commercial Manufacturing
  • Methods Validation Characteristics – Robustness, Specificity, Accuracy, Precision, Linearity, Limit of Detection, Limit of Quantitation, Range
  • Methods Verification, Qualification and Validation with Examples
  • Challenges with Biological Methods or Bioassays
  • Tracking and Trending of Method Performance
  • Potency Tests for complex Biological Products
  • Myths and Regulatory Expectations about Bioassays
  • Role of Critical Reagents, Reference Standards and Controls and their Development and Qualification
  • Regulatory Expectations for a Potency test
  • Designing Methods "Suitable for Intended Purposes" to Mitigate Risks due to Errors and Out of Specification (OOS) Results
  • Risks and Inherent Variability of Analytical Methods
  • How to Continuously Monitor Method Performance and achieve sustainable compliance of methods for regulatory requirements?
  • Changes to Approved Methods – Change Control, Comparability Protocols

Analytical Methods in Development and Manufacture of Drugs and Biologics brings together:

  • Biotech Industry
  • Pharmaceutical Industry
  • Analytical Development Scientists involved in method development, qualification and validation of methods
  • Managers and Scientists involved in Drug Development
  • Quality Assurance Staff for Informed Review of Data and for Managing and Providing Oversights on Investigations, Change Control, etc
  • Quality Control Scientists Involved in Performing Routine Testing and Monitoring Method Performance


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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