ComplianceOnline

Good Laboratory Practice Regulations

Instructor: Dr. Ludwig Huber
Product ID: 700204
Training Level: Advanced
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

In this Laboratory compliance training Understand what GLP means for a laboratory and what the compliance requirements are.

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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