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Introduction to Photostability
A Practical Introduction to
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Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ)
| Type | Course |
|---|---|
| Language | English |
| Date |
July 22, 2009 from 08:30 am to 05:00 pm |
| Venue |
University of South Florida, Downtown Center 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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Understand the process for design, installation, operation and performance (DQ, IQ, OQ, PQ) in the analytical laboratory. Learn what regulatory and quality systems requirements are for compliance and conformity, how to implement qualification and validation systems and keep them current to meet business needs, how to perform necessary maintenance through PM, and how to adapt your current GLP system to meet changing requirements.
Key Topics
* What the regulatory (cGMP, GLP) and quality systems (e.g., ISO-9001, ISO-17025) requirements are for compliance and conformity.
* How to implement qualification and validation systems and keep them current to meet business needs.
* How to perform necessary maintenance through PM.
* How to adapt your current GLP system to meet changing requirements.
Session titles
* The Product Lifecycle Concept.
* Quality Control (QC), Quality Assurance (QA) Roles vis-à-vis Validation Process.
* FDA’s New Initiatives in Systems Based Inspection.
* ISO-17025, ISO-9001-2000 and Other International Quality Systems (QS) and Guidelines.
* Master Validation Plan and Documentation.
* Training and Awareness.
* Insight into a Generic Approach to Validation.
* Discussions on cGMP, GLP, WHO, and OECD Requirements and Expectations.
* General QA Expectations in Analytical and Microbiological Laboratories.