Course Description:
Analytical methods ensure quality of drugs and biologics. During last 2 decades, paradigm for quality of pharmaceutical products has shifted from ensuring quality by testing representative samples to building quality during manufacture of such products, leading to the concept of Quality by Design (QbD). This course starts with discussing the new paradigm of quality, QbD, and role of analytical methods in ensuring quality.
Methods play a critical role in development and manufacture of drugs and biologics and should be considered as a "Life Cycle" approach throughout the life cycle of a pharmaceutical product. The methods must be suitable for intended purpose during different stages of development and for commercial manufacture of the product. Understanding regulatory expectations and requirements for the methods is important to develop and design methods that are not only suitable for intended purpose, but support manufacturing operations in release of the product in a timely manner. All methods used in manufacturing operations must be maintained in a compliant state with acceptable method performance during life cycle of the product. This course will go into details of the life cycle of analytical methods, including verification, qualification and validation of methods for various stages of product development and for various purposes during manufacturing operations. Appropriate methods attributes and parameters will be discussed that need to be monitored (tracking and trending) to evaluate method performance.
Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Biological methods or bioassays with large inherent variability have challenges in developing appropriate method so that these are suitable for intended purpose. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. This course will further go into the challenges, regulatory expectations and myths about bioassays with focus on developing suitable bioassays for intended purposes.
One of the challenges in developing cutting edge products, including cellular, tissue, gene therapy products, vaccines and blood products is developing appropriate potency method for these products. Often protective mechanisms for such products or surrogate markers for efficacy of such products are not clearly defined. There are examples of use of highly variable animal based methods as potency tests, which are sometimes poor indicators of human efficacy. In such cases, the concept of consistency in manufacture is employed to develop appropriate potency test, which may be a single test or a combination of tests. This course will go through regulatory expectations in developing potency tests for biological products.
Critical Reagents, Reference Standards and Internal controls play an important role in ensuring validity of results generated by analytical methods, particularly biological methods, and also to ensure acceptable performance of the method over time. This course will also discuss about selection and qualification of critical reagents, reference standards and internal controls for generating reliable results.
Throughout the course, specific examples with regard to achieving regulatory compliance during inspections, audits and review of methods sections, as part of license applications or supplements to license applications will be discussed. More importantly, information on the design of robust methods "Suitable for Intended Purposes" will be provided to mitigate risks of mistakes/errors and out of specification (OOS) results.
Who Will Benefit:
- Pharmaceutical Industry
- Biotech Industry
- Managers and Scientists involved in Drug Development
- Analytical Development Scientists involved in method development, qualification and validation of methods
- Quality Control Scientists Involved in Performing Routine Testing and Monitoring Method Performance
- Quality Assurance Staff for Informed Review of Data and for Managing and Providing Oversights on Investigations, Change Control, etc.
For Registration - http://www.complianceonline.com/pharma-biotech-analytical-method-development-qbd-workshop-by-ex-fda-seminar-training-80404SEM-prdsm?channel=eventzilla
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
