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Good Laboratory Practice Regulations
In this Laboratory compliance training Understand what GLP means for a laboratory and what the compliance requirements are.
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| Product ID: 700204 |
| Training Level: Advanced |
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Description
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.
Additional benefits
Attendees will receive a 120 page primer, and 3 SOPs and a checklist for implementation.
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 on what GLP means for a laboratory and what the requirements are.
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
What Attendees will Learn
- FDA and International GLP regulations: 21 CFR Part 58
- 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
- Preparing for FDA inspections
Who Will
Benefit
- Lab Supervisors and Managers
- QA managers and personnel
- GLP auditors
- Analysts
- IT managers and personnel
- Consultants
- Teachers
Instructor Profile
Ludwig Huber, Ph.D., is Compliance
Program Manager at Agilent Technologies. He is the editor of http://www.labcompliance.com/, the global on-line resources
for validation and compliance issues for laboratories. He is the author of the
books "Computer System Validation", "Network Quality Package" , and "Validation
of Computerized Analytical and Networked Systems".For more information, visit
Dr. Huber's website: http://www.ludwig-huber.com/
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