Qualification and Validation of Analytical Methods for Protein Products
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Who Should Attend
This intensive 2-day training is designed for professionals,
especially scientists, chemists, managers, supervisors and
directors, involved in managing any aspect of analytical
lifecycle in biotechnology and biopharmaceutical industry
including, but not limited to:
• Analytical Development
• Quality Control
• Quality Assurance
• Regulatory affairs
• Process Development
Description
The Q2R1 ICH guidance document on method validation
covers activities required for product registration. There is no
specific guidance on method validation for earlier stages of
product development. The generally accepted term for these
pre-commercial activities is method qualification, but the
scope and timing of qualification with respect to the various
stages of product development, and the relationship of
qualification to validation activities has not been consistently
delineated or practiced across the industry.
The objective of this training is to provide deep understanding
for all terms associated with qualification and validation of
analytical methods developed to test quality attributes of
protein products, and their stage appropriateness. Emphasis
is placed on explanation of important scientific concepts
associated with determination of method precision,
LOD/LOQ, and uncertainty of reported results. Additionally,
the training will help to organize these concepts into simple
logical lifecycle, properly aligned with other processes
involved in the development of protein therapeutics.