Strategies for Qualification of Biological Reference Standards

Website http://www.onlinecompliancepanel.com/webinar/BiologicalReferenceStandards-501055/OCT-2015-ES | Edit Freely

Category Reference Standards, Biopharmaceuticals, Cell-Based Assays, International Standards, Large Molecule Therapeutics, Cross Validation

Deadline: October 13, 2015 | Date: October 14, 2015

Venue/Country: online Webinar, U.S.A

Updated: 2015-10-06 15:51:35 (GMT+9)

Call For Papers - CFP

Instructor: Gwendolyn Wise-Blackman

Product ID: 501055

Description

Biopharmaceuticals may not have international standards available and can be dependent on a fully characterized batch set aside as the reference standard. Data may not be available on the stability profile to allow continued use of a single batch over an extended time. Procedures should be in place to characterize and qualify the selected reference standard that prevents any gaps in availability.

Areas Covered

Identification of reference standards

Process controls

Maintaining supply

Equivalence testing with international standards

Establishing a new international standard

Establishing expiration dates

Cross validation with new lots of material

Manufacturing changes

Correction factors

Why Should you Attend

This course will provide guidance and information necessary to build an effective program to qualify biological reference standards.

Objectives of the Presentation

Establishing reference standards

Understanding the effects of changes in production

Identifying and controlling quality issues

Determining adequate supply

Selecting storage conditions

Managing unexpected issues

Who can Benefit

Quality Assurance

Quality Control Professionals

Laboratory Scientists working in Analytical Development and Validation

For Registration -

http://www.onlinecompliancepanel.com/webinar/BiologicalReferenceStandards-501055/OCT-2015-ES

Note : Use coupon code 1371 and get 10% off on Registration