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Webinar On Good Laboratory Practice Regulations - Introduction and Strategies for Implementation

 
  January 16, 2015  
     
 


Compliance Trainings, Canada
2015-02-19


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, or 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. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.

Areas Covered in the Session :

FDA and International GLP regulations: 21 CFR Part 58, OECD

Examples for FDA 483 inspectional observations and warning letters

Objectives, scope 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

Strategies for Multi-site GLP Studies

Preparing for FDA inspections

Who Will Benefit:

Everybody getting involved in GLP studies

Lab Supervisors and managers

QA managers and personnel

GLP auditors

Analysts

Consultants

Teachers

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : 4169154458 
Email : support@compliancetrainings.com

 
 
Organized by: Compliance Trainings
Invited Speakers:

Speaker Profile

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, 21CFR Part 111 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. For more information, please visit Dr.Huber's website (www.ludwig-huber.com).

 
Deadline for Abstracts: 2015-02-19
 
Registration:

https://compliancetrainings.com/siteengine/Login.aspx

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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