Analytical Methods Validation for FDA Compliance
April 20 - 22, 2009
Amsterdam, The Netherlands
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for individuals who have the responsibility
for establishing the integrity of analytical methods for active
pharmaceutical ingredients (APIs) or finished pharmaceutical
dosage forms. This course will benefit individuals in:
• R&D
• Quality Control
• Quality Assurance
• Technical Operations
Regulatory Affairs personnel responsible for the review of such
data will also benefit from this course.
Description
One of the most critical factors in developing and marketing
pharmaceutical drug substances and drug products today is
ensuring that the analytical methods used for analysis can
generate valid data upon which business and regulatory decisions
can be made. FDA, ICH and USP have each recognized the
importance of this to the drug development process and have
separately expanded method validation requirements in recent
years. However, with only limited guidance, industry has been left
to interpret how to adequately comply with the regulations.
Whether involved in method development, method validation,
method verification or method transfer, this course will provide
a broad understanding and “hands-on” knowledge of the method
validation process and the difficulties encountered in validating
methods to comply with today’s upgraded FDA CDER
requirements. Lectures will include not only theoretical basis and
practical applications, but actual validation examples of HPLC, GC,
UV/Vis, AA, and titration methods for small organic molecules.
Some of the more common mathematical and statistical
treatments of validation data will also be discussed. Because
of the tremendous effort that can be expended in conducting
validation studies, efficiency of experimental design and
documentation will be stressed throughout the discussions.
Although the general principles in this course may be applied to
methods for testing biological molecules and medical devices,
the focus of this course is on the validation of methods for the
analysis of small molecules.