Analytical Methods in Development and Manufacture of Drugs and Biologics 2016 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 2016 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
