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Healthcare Training 2016 - Healthcare Training by Compliance4all on Good Laboratory Practice Regulations

Date2016-11-02

Deadline2016-11-01

VenueFremont, USA - United States USA - United States

KeywordsGood Laboratory Practice; Introduction to Good Laborator; Organizational requirements

Websitehttps://www.compliance4all.com/control/w...

Topics/Call fo Papers

Overview:
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.
Areas Covered in the Session:
FDA and International GLP regulations: 21 CFR Part 58, OECD
Objectives and concepts of GLP's
Special organizational requirements
Responsibilities: Management, Study director, QA, analysts
SOP requirements: type, formats and enforcement
GLP studies: preparation, conduct, documentation
Key requirements for equipment, facilities reference material, people
Data generation and evaluation: raw data, intermediate results, final results
Records keeping: format, length of time, archiving and reprocessing
For easy implementation, Attendees will receive:
Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
Gap Analysis/Checklist: Good Laboratory Practice Regulations
SOP: Archiving GLP Data and Other Documents
Who Will Benefit:
Lab Supervisors and Managers
QA managers and personnel
GLP auditors
GLP study directors
Analysts
Consultants
Teachers
Speaker Profile:
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~p...
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Last modified: 2016-09-28 15:18:40