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Course Description:

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. Some of the key aspects of the seminar include:

  • Learning how to apply QbD concepts to analytical methods
  • Discussing the types of methods required for different drug products
  • Understanding the types of impurities which must be addressed for drug products
  • Discovering how a lifecycle approach can link method development, validation, verification and transfer
  • Learning how ATP (Analytical Target Profile) can drive the lifecycle approach
  • Determining the importance of linking method uncertainty to specifications
  • Using a method feedback loop to facilitate method improvement

This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.

For Registration

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Conference/Event Dates: 03/19/2015 - 03/20/2015
Conference/Event Hours: 8:30 AM to 4:30 PM
Classification: B2B
Primary Industry: Pharmaceutical
Other Industries: Pharmaceutical, Professional Healthcare
Estimated Attendance: 30
Cost to Attend: One Registration- $1499
Audience: Chemists (Research, Quality Control, CRO)
Regulatory Affairs/CMC Personnel
Laboratory Managers and Staff
QA/QC Managers and Personnel
Venue: Hyatt Regency Washington
Venue Phone: (202) 737-1234
Venue Type: Indoor - Hotel
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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Lifecycle Approach to Analytical Methods for Drug Products

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