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Lifecycle Management of Analytical Methods and Procedures
04/04/2017 @ 8:30 - 04/05/2017 @ 16:30| €1899
Results of analytical methods and procedures are used as the key basis to make important decision during development and manufacturing of pharmaceutical products. Therefore all regulatory agencies expect the regulated industry to have procedures and measurements in place to ensure highest reliability, accuracy and precision of such methods and procedures. The procedures should cover all lifecycle phases from design, development, validation to on-going routine use.
Managing analytical methods and procedures according to the lifecycle approach got highest attention from regulatory agencies and industry task forces. For example, the new FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” starts with suggestions for method development and includes a chapter on Lifecycle Management of Analytical Procedures. USP’s Validation and Verification Expert panel just proposed a new general chapter 1220: The Analytical Procedure Lifecycle.
The 2-day workshop will give attendees the background to understand the new Analytical Procedure Lifecycle requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. It also provides 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 life examples.. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available at no additional cost on a dedicated website that can be used by attendees to easily implement what they have learned in the course.
Who will Benefit:
QA managers and personnel
Laboratory managers and supervisors
Companies and departments
Pharmaceutical development and Quality control laboratories
Quality control laboratories of API manufacturers
Clinical Research Organisations
Medical device companies
Use coupon code NB5SQH8N and get 10% off on registration.