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EVENT DATE
Oct 2017
M T W T F S S
09101112131415
EXPO DATE
Oct 2017
M T W T F S S
09101112131415

Venue

Venue TBD
Philadelphia , PA 19107
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Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer

Venue TBD
B2B 30

EVENT DESCRIPTION

Top 5 Reasons to Attend this Seminar:

  1. Learn how to use a Lifecycle Approach to apply QbD concepts to Analytical Methods
  2. Learn how the Analytical Target Profile can drive the Lifecycle Approach
  3. Discover how a lifecycle approach can link method development, validation, verification and transfer and continued method use
  4. Learn about the importance of linking method uncertainty to specifications
  5. Using a method feedback loop to facilitate method improvement

This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. The course starts by introducing the Lifecycle Approach and discussing some of the key terms. By using the 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. This approach will be linked with current compendial requirements. There will be an opportunity for questions and interaction throughout the course.

Who will Benefit:

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.

Note: Use coupon code REFERRAL10 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/applying-qbd-concepts-to-method-development-validation-verification-transfer-of-drug-products-seminar-training-80236SEM-prdsm?channel=eventsinamerica

There may be many networking opportunities at the Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer. Find out more in the event details below.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Sciences
Other Industries:
Business, Sciences
Audience:
Chemists, supervisors, managers or directors
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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