Course Description:
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.
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. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.
Learning Objectives:
Attendees will:
- 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
- Be able to explain your company’s strategy for method validation, verification, transfer and equivalency testing
- Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
- Be able to justify and document decisions about revalidation after method changes
- Be able to define and demonstrate FDA and EU compliance to auditors and inspectors
- Be able to develop inspection ready documentation during on-going routine operation
- 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 (available as web downloads):
- 70-page primer: Validation of analytical methods (authored by Dr. Ludwig Huber)
- 10 SOPs related to validation, verification, transfer, review and change of analytical methods
- 10 checklists, templates and examples
- Acceptance criteria for different analytical tasks
Who will Benefit:
- QA managers and personnel
- Quality control
- Method development
- Analytical chemists
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs
- Training departments
- Documentation departments
- Consultants
Companies and departments:
- Pharmaceutical development and Quality control laboratories
- Quality control laboratories of API manufacturers
- Contract laboratories
- Clinical Research Organization
- Medical device companies
Course Outline:
All sessions indicated include one or more workshop exercises
| Day One (8:30 AM - 4:30 PM) | Day Two (8:30 AM - 4.30 PM) | ||
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8:30 AM - 9:00 AM: Registration Process 9:00 AM: Session Start Lectures and Workshop Exercises Lecture 1 - Regulatory Background and Requirements
Lecture 2 - Preparing Your Lab for Validation Studies
Lecture 3 - Validation of Analytical Methods and Procedures
Lecture 4 - Verification of Compendial Methods
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Lectures and Workshop Exercises Lecture 5 - Transfer of Analytical Methods and Procedures
Lecture 6 - Demonstrating Equivalency to Compendial Methods
Lecture 7 - Maintaining the Validated State
Lecture 8 - Special Applications and Validation Processes
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The concept
- 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive discussions
Meet Your Instructor
 |
Dr. Ludwig Huber Chief Advisor - Global FDA Compliance, Labcompliance Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare." He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies. |
Register Now
Watch the live recorded streaming video of seminar over the Internet.
The seminar broadcast includes speaker videos and coordinated PowerPoint presentations.
Contact [email protected] or call +1-888-717-2436 to get registration details.
Terms & Conditions to Register for the Live Recorded Streaming Video of Seminar
Your registration is subject to following terms and conditions. If you need any clarification before registering for this video of seminar please email us at [email protected] or call +1-888-717-2436
Payment:
After receiving the payment, our team will send you the instructions to access live recorded streaming video of seminar. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellation Policy:
Once the video access is given to customer, cancellation and refunds cannot be made.
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