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Training:
Validating HPLC Methods
Who should take this course?
If you are now or will be developing HPLC methods and have questions
about method validation, documentation, and regulatory compliance
issues, then this is the course for you. Attendees should have
completed the Advanced HPLC Method Development course or have
equivalent experience (at least one year of HPLC method development
work). This course is not for novices or beginning chromatographers.
What does it cover?
In this intensive two-day course, you will learn both how to avoid
expensive validation problems and how to take advantage of the
information provided by a well-designed, well-implemented validation.
This course includes:
- How to adapt, qualify,
and modify USP methods
- How to validate methods
in ways that will minimize method transfer problems
- How to develop a robust
HPLC method and fulfill the FDA's requirements in the QC operations in
pharmaceutical, biotechnology, and related industries.
- How to avoid unpleasant
"surprises" during validation
- How to avoid regulatory
problems with FDA or EPA during audits by having proper documentation
for all your submissions
- Learn the ins and outs of
the FDA's New Millennium Directives, cGMP requirements, and the
Guidance for Validation of Analytical Methods
- Familiarizing yourself
with safe and sound approached for validating your HPLC method right
from the beginning
- Learning about the
Guidance for Laboratory Controls Systems as outlined in the CRF and
elsewhere from FDA
- Familiarize yourself with
the contents and format of submission packages related to NDA, IND,
ANDA, and other stages of drug discovery, development, and marketing
- Learning about
documentation strategies to meet FDA requirements
Schedule for this course
Course Outline
Introduction and Basic Concepts
Overview: General
Approach to Validation
Measurement Process and Errors
-
Classification of Errors
- Analytical Methods, Purpose, and Errors Involved
- Measurement Resolution
Incorporating Validation into the Method Development Process
Definitions of Key Validation Parameters: General, USP, ICH, FDA
Regulatory Guidelines
- Tables of Data and Acceptance Criteria
- FDA Guidelines for IND, NDA, ANDA, and Submission Packages
- Practical Examples
Conclusion
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