RAPS pre-approved webinar on "Good Laboratory Practice Regulations -Introduction and Strategies for Implementation"

GlobalCompliancePanel, a leading regulatory and compliance training provider, will organize a RAPS pre-approved webinar on the topic,"Good Laboratory Practice Regulations -Introduction and Strategies for Implementation" on October 25.

Wilmington, DE (prHWY.com) September 21, 2012 - Description:
This webinar helps analytical laboratories adapt GLP's in overcoming the challenges faced in analyzing biological fluids.
Analyzing biological fluids is a very arduous work for a laboratory. The FDA stipulates rules and industry recommendations for the correct validation of bio-analytical methods. This is done to ensure reliability, consistency and accuracy of bio-analytical data. But obtaining this is not very easy, especially since a combination of matrices and decomposition products with low concentrations of analyte interferes with the process.
There is only one strong method of overcoming these obstacles, and that is to implement Good Laboratory Practices (GLP).
GLP's may the solution, but their implementation is neither automatic nor without costs. When they are not implemented properly, they can increase the cost of compliance with regulation for the laboratory by some 30 per cent. In addition to these increased costs; their non-implementation can lead to failures in analyzing biological fluids, something that can attract penalties.
So, what is the solution to this "damned if you do, damned if you don't" kind of situation? This is what is going to be imparted at this webinar. It will give a good understanding of GLP regulations and recommendations and tools for implementation. To make comprehension of the topic easier, it gives participants the following reference material:
o Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
o Gap Analysis/Checklist: Good Laboratory Practice Regulations
o SOP: Archiving GLP Data and Other Documents
This webinar covers the following areas:
o FDA and International GLP regulations: 21 CFR Part 58, OECD
o Objectives and concepts of GLP's
o Special organizational requirements
o Responsibilities: Management, Study director, QA, analysts
o SOP requirements: type, formats and enforcement
o GLP studies: preparation, conduct, documentation
o Key requirements for equipment, facilities reference material, people
o Data generation and evaluation: raw data, intermediate results, final results
o Records keeping: format, length of time, archiving and reprocessing
o Preparing for FDA inspections
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When: October 25, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of many books, including Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems.

He also has more than 100 literature publications and conducts online tutorials regularly. His works speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a renowned expert on not only the FDA but also other regulatory bodies is evident from the fact that he has been Chief Advisor on Global ISO 17025 and FDA Compliance.
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For whom:
The webinar will benefit
o Laboratory managers and supervisors
o GLP auditors
o GLP study directors
o QA/QC managers and personnel
o Analysts and other laboratory staff
o Regulatory affairs
o Training departments
o Consultants
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Duration: 75 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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Tag Words: dhf, dmr, dhr, usfda, eu mdd requirements, design dossier, online training, european union

Categories: Health

Press Release Contact
GlobalCompliancePanel
Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

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