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Introduction to Photostability
A Practical Introduction to
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Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory
| Type | Course |
|---|---|
| Language | English |
| Date |
July 20, 2009
to July 21, 2009 |
| Venue |
http://www.outreach.usf.edu/downtown/index.asp 1101 Channelside Drive - Suite 100 Tampa, FL 33602 US |
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| Contact |
American Chemical Society 1155 Sixteenth Street, NW Washington, DC 20036 US (800) 227-5558 shortcourses@acs.org |
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Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions. Key topics covered include: conformity assessment; analytical method optimization during development; case studies in the improvement of validation characteristics; data integrity and statistical evaluation of analytical data; and more.
Key Topics
* Highlights of the guidelines derived from international standards-ISO 9000 and ISO 17025, GLP, GMP, etc.
* Conformity assessment–what it is, how it is applied.
* Analytical method optimization during development.
* Case studies in the improvement of validation characteristics.
* Method development and optimization in HPLC and wet chemistry.
* ICH, AOAC, and USP guidelines for methods validation and other standards.
* Regulatory submission packages for IND, NDA, ANDA and other phases of development.
Session titles
* Fundamentals - Quality, Quality Control, and Quality Assurance—general discussions on quality, QC, QA, and guidance from domestic and international standards; definitions and descriptions of validation parameters; principles of method validation, conformity assessment and laboratory QA.
* Method Validation - Guidelines Derived from GLP, AOAC, ISO 9000, and ICH—examples of development and optimization of methods ab initio and development of validation criteria; definition of ruggedness, reproducibility, system suitability, precision, accuracy, LOD, LOQ and other validation parameters for FDA compliance.
* Method Development and Optimization by Example and Case Studies - How to systematically develop and optimize an assay for a trace component in a very complex sample matrix.
* Method Development and Optimization in HPLC as an Example of a Current Analytical Techniques - Aspects of HPLC that need to be developed, and optimized, including procedures; peak purity, spectral match, peak tailing and other considerations in HPLC.
* Methods Optimization Considerations in Spectroscopic (UV-VIS, AA) and Classical Techniques - Statistical treatment of data: practical examples and case studies.
* Statistical Treatment of Analytical Data - Mean, Mode, Standard Deviation, Control Charts, etc.
* Statistical Process Control (SPC) Applications for Process Improvement and Process Optimization