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Course description

Key Topics Covered:

Who Should Attend?

Learning Outcomes

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.
Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation. Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements.

This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations.
About 50% of the total time will be dedicated to practical sessions with real life examples.

• QA managers and personnel

• Quality control

• Analytical chemists
• Laboratory managers and supervisors

• Regulatory affairs

• Training departments
• Documentation departments
• Consultants

• Learn about the regulatory background and requirements for validation of analytical methods and procedures

• Learn how to plan, execute and document development and validation of methods developed in-house

• Be able to explain the different requirements for validation, verification and transfer of analytical procedures

• Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods

• Understand statistical evaluation of validation test results

• Understanding what questions will be asked during audits and inspections and how to answer them

• Handouts/ Bonus Material for Easy Implementation

• Acceptance criteria for different analytical tasks

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Section 1
Final Quiz