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QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives
Tuesday, February 5, 2013 from 10:00 AM to 12:00 PM (PST)
Palo Alto, CA
This 2-hr webinar will provide you a comprehensive understanding of the requirements for validation, verification and transfer of pharmaceutical analytical methods. A lifecycle approach will be presented to establish the expectations for the method, after which key guidance documents will be reviewed.
Why Should You Attend:
This interactive course is designed to provide participants with an understanding of the requirements for validation, verification and transfer of pharmaceutical analytical methods. A lifecycle approach will be presented to establish the expectations for the method, after which key guidance documents will be reviewed. Different types of methods will be addressed, including those focusing primarily on the active, stability indicating methods and dissolution methods. The similarities and differences between validation, verification and transfer will be discussed and used to formulate protocols which are appropriate to a variety of situations. Establishment of acceptance criteria are a key component of these protocols, and the rationale for selecting criteria will be discussed. Some common issues which arise during these experiments will be discussed, including ways to recognize and address problems.
Upon completion of the course the learner should be able to:
- Identify the various stages in the lifecycle of an analytical method and the expectations at each of those stages.
- Discuss the appropriate guidance documents related to method validation, verification and transfer.
- Identify the required elements for method validation, verification or transfer experiments.
- How to design experiments, write validation protocols, establish acceptance criteria and document results.
- Troubleshoot methods which are not performing well.
Date: February 05 , 2013
Time: 10:00 AM -12:00 PM PST
Cost: $299 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.