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Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelin

Start Date:
Tuesday, 12 September, 2017
End Date:
Wednesday, 13 September, 2017 4:30pm
Speciality:
Business Practice
Website:
http://www.complianceonline.com/lab-analytical-compendial-method-ich-q2-glp-part11-annex11-qbd-seminar-training-80291SEM-prdsm?channel=meetings4docs

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.

Who Will Benefit:QA managers and personnelQuality controlMethod developmentAnalytical chemistsValidation specialistsLaboratory managers and supervisorsRegulatory affairsTraining departmentsDocumentation departmentsNote: Use coupon code REFERRAL10 and get 10% off on registration.For Registration:http://www.complianceonline.com/lab-analytical-compendial-method-ich-q2-glp-part11-annex11-qbd-seminar-training-80291SEM-prdsm?channel=meetings4docs

Location

Courtyard Boston Cambridge 777 Memorial Drive,
Cambridge,
Massachusetts,
02139,
United States

Organizer Details

Conference organized by ComplianceOnline

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.

Address:
2479 East Bayshore Road Suite 200
Phone:
+1-888-717-2436
Email:
referral@complianceonline.com

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