Course offering number:1203-203
Course ID:
1887
Analytical Methods Validation for FDA Compliance
March 7-9, 2012
Burlingame, CA
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 and not the unique analytical
procedures often used for testing products of a biological nature.
Other Courses of Interest
Active Pharmaceutical Ingredients
May 21 2012, New Brunswick, NJ
Active Pharmaceutical Ingredients
Jun 27 2012, Amsterdam, The Netherlands
Calibration in the FDA Regulated Industry
Developing Specifications for Drug Substances and Drug Products
May 07 2012, Burlingame, CA
Drug Product Stability and Shelf-Life
Mar 05 2012, New Brunswick, NJ
Drug Product Stability and Shelf-Life
May 30 2012, Amsterdam, The Netherlands
ICH-Q7
Mar 19 2012, New Brunswick, NJ
ICH-Q7
Jun 25 2012, Amsterdam, The Netherlands
Laboratory Control System
Root Cause Investigation for CAPA
Apr 17 2012, Amsterdam, The Netherlands
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