Analytical Methods in Development and Manufacture of Drugs and Biologics 2016

Key Topics

• 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

Who should Attend

• 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