ComplianceOnline

Good Laboratory Practice Regulations

Instructor: Dr. Ludwig Huber
Product ID: 700204
  • 22
  • September 2017
    Friday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min

Live Online Training
September 22, Friday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD free!

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 48 hrs after completion of Live training

Training CD

$349.00
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 after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$449.00

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 them. Get practical recommendations from industry leading expert Dr. Ludwig Huber.

Complimentary Hand-outs:

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
  • Part 11 Checklist
  • Part 11 Compliance Master Plan
  • Case Studies : How to avoid Part 11 related 483's and Warning Letters
  • Case Studies: How to respond to Part 11 related 483's and Warning Letters

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 online training 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 comply with 21 CFR Part11 to ensure data integrity, and how to archive GLP data and 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 Webinar:

  • 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
  • 21 CFR Part 11 compliant generation, evaluation and archiving of 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
  • GLP study directors
  • Analysts
  • Consultants
  • Teachers
  • Pharmaceutical Research
  • Pharmaceutical development
  • Contract laboratories
  • CROs
Instructor Profile:
Dr. Ludwig Huber

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, 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". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

Follow us :
Validation, Verification and Transfer of Analytical Methods
Upcoming In-person Seminars by EX-FDA OFFICIALS

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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