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Lifecycle Approach

Zoom in  Zoom out Publish date: 2014-03-14   Hits: 118   Status: Status
Date 2014-05-20 to 2014-05-20
City Michigan
Address 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
Exhibition hall on line
Sponsor John Gordan

Event Description
This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location  or evolve technically. Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

Online Regulatory Compliance Training, Compliance Training, regulatory compliance training, Online compliance Training, e-learning, Regulatory standards Guidelines, Best Practices, Regulatory Compliance, Compliance Management, Corporate Compliance, Compliance Solutions, FDA and ISO regulations, Process and Design Validation, Online Compliance, Global Compliance, Medical Devices Directive, ISO Compliance, ISO14971, ISO 14971:2007, Global Compliance Trainings, Online Training, Online Trainings

Live Session for one participant

Price: $225.00

 

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Corporate Live Session 4 to 10 participants in single location.

Price:$885.00

 

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Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.

Price: $275.00


Contact information
Contact: webinar@globalcompliancetraini
Tel: +1-248-212-0588
 
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