QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer - Webinar (Pharamaceutical)
Venue: Online Event
|Event Date/Time: Mar 29, 2011||End Date/Time: Mar 29, 2011|
Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Demonstrating that these methods consistently perform appropriately for their intended purpose can be both challenging and resource intensive. By using a pro-active, quality-by-design (QbD) approach, it is possible to design better methods, understand the strengths, weaknesses and capabilities of those method and to perform validation exercises in a scientifically rational way that will maximize success and minimize overall resource consumption. This is especially true for the method transfer process, where many examples of tremendous complication can be cited due to inadequacy in method design and development, and due to inappropriate design of method transfer protocols.
This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. This approach will be linked with current compendial requirements.
After attending this course, youâ€™ll understand the interconnectedness of these phases in the lifecycle of an analytical method and be prepared to plan for success. By appropriate planning, you can avoid the pitfalls of methods which fail validation protocols, of â€˜validatedâ€™ methods which do not perform adequately in routing use and of transfers to other sites which fail, resulting in production delays, regulatory scrutiny, frustration and waste of valuable resources.
Upon completion of this course the learner should be able to:
Understand the lifecycle approach to method development and validation.
Identify an Analytical Target Profile for Methods Being Developed.
Use an IQ/OQ/PQ Approach to Method Qualification.
Develop Appropriate Protocols for Method Transfer.
Comply with Compendial Requirements with Greater Success and Fewer Resources.
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