QbD Approach to Analytical Method Lifecycle - Webinar By ComplianceOnline
QbD Approach to Analytical Method Lifecycle - Webinar By ComplianceOnline
Why Should You Attend:
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, you'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 validated' 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.
Areas Covered in the seminar:
Comparison between Traditional Approaches and QbD Lifecycle Approach to Method Validation.
QbD Framework for Analytical Method Lifecycle Method Design Analtyical Target Profile
Method Development
Method Understanding
Method Qualification Method IQ (Facilities)
Method OQ (Validation)
Method PQ (Real Samples)
Continued Method Verification Change Control
Method Transfer
Method Verification
Correlating This Approach with Compendial Requirements.
Attendee Questions and Answers
Learning objectives:
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.
Who Will Benefit:
This webinar will provide valuable assistance to all Biotech & Pharmaceutical companies/ manufacturing sites. Those that would benefit most would be:
Chemists (Research, Quality Control, CRO) involved with analytical method development, validation or transfer and their managers
Regulatory affairs/CMC personnel responsible for documenting analytical methods and their acceptability
Laboratory managers and staff
Analysts
QA/QCU managers and personnel
Training department
Documentation department
Consultants
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