ComplianceOnline

Good Laboratory Practice Regulations - Introduction and Strategies for Implementation

Instructor: Dr. Ludwig Huber
Product ID: 701765
  • Duration: 75 Min

recorded version

$349.00
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
Last Recorded Date: Oct-2010

Training CD / USB Drive

$600.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with it. Get practical recommendations from industry leading expert Dr. Ludwig Huber.

Why Should You Attend:

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.

Attend this webinar to understand what is GLP, who has to comply, differentiations of US and International regulations on GLP, how to archive GLP data, document GLP and protocols. Dr. Huber will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, checklists, templates and examples will help immediate and cost effective implementation.

Areas Covered in the Seminar:

  • 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.
  • Preparing for FDA inspections.

Hand-Outs:

For easy implementation, attendees will receive

  • Part 11 Checklist
  • Part 11 Compliance Master Plan
  • Case Studies
  • How to avoid Part 11 related 483's and Warning Letters
  • How to respond to Part 11 related 483's and Warning Letters
  • 30 FDA Warning Letters from 2007 to 2010 (Web downloads) with deviations related to computer systems and Part 11 compliance.

Who Will Benefit:

  • Lab Supervisors and Managers
  • GLP auditors
  • GLP study directors
  • Analysts
  • IT managers and personnel
  • Consultants
  • Teachers

Instructor Profile:

Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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