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GLP Training Course on the Understanding and Implementation of the OECD Principles of GLP

6 Jul 2015 - 10 Jul 2015
Hangzhou, China
ChemLinked
Details

 

View GLP Training Course 2014

 

The GLP Training Course 2014 was held with great success by ChemLinked last year. This summer we have invited again Mr. Hedwig Beernaert, a veteran in OECD GLP with over 20 years expertise to offer another training course on GLP quality systems. 

 

A five-day course will be delivered to attendees to learn/review the requirements of the Good Laboratory Practice (GLP) regulations set forth by the OECD, understand GLP compliance and to be able to recognize non-GLP compliance situations. Responsibilities of sponsors, management, the study director, study personnel, and the quality Assurance Unit (QAU) will be discussed.This course is structured to be intensive. To have a much stronger interaction between the trainer and trainees on one side and between the trainees on the other side, the number of attendees will be limited to 25 persons and will include plenty of opportunities for questions and discussions.

 

Certificates will be awarded to the attendees after successful completion of the training course. After having been trained, all trainees are expected to be able to implement good laboratory practices and have a deep knowledge of monitoring the performance in laboratory.

 

Course Schedule

  • Date: July 6th ~ July 10th, 2015 (Mon ~ Fri)
  • Time: 9:00 ~ 13:00, 14:00 ~ 18:00
  • Language: English
  • Venue: to be determined (Hangzhou, China)

 

The course schedule could be the following:

  • Day 1: general GLP aspects, responsibilities and QA program
  • Day 2: facilities, apparatus, SOPs and archives
  • Day 3: computerized systems, test item, test systems
  • Day 4: performance of studies
  • Day 5: reporting of studies

 

The course will be highly interactive with intensive case studies and exercises to enhance its effectiveness.

Schedule

Morning Session (9:00~13:00)

Afternoon Session (14:00~18:00)

Day 1

  1. Introduction
  2. Individual exercise about the knowledge of the GLP Principles
  3. General GLP aspects
  4. Organization process and responsibilities?
  1. Master schedule of GLP studies
  2. Individual exercise on responsibilities
  3. Team exercise on the organization process

 

Day 2

  1. Quality Assurance program
  2. Facilities
  3. Standard operating procedures (SOPs)
  1. Individual exercise on SOPs
  2. Team exercise on the QA Program

Day 3

  1. Apparatus, materials and reagents
  2. Computerized systems
  1. Individual exercise on apparatus, materials and reagents
  2. Team exercise on computerized systems

Day 4

  1. Performance of studies
  2. Test item
  3. Test systems
  1. Individual exercise on test items and systems
  2. Team exercise on performance of studies

Day 5

  1. Reporting of studies
  2. Archiving
  1. Individual exercise on archiving
  2. Team exercise on reporting of studies

 

 

Highlights:

  1. A questionnaire distributed after a small introduction to evaluate the knowledge and understanding of GLP Principles of the participants
  2. Each morning session: GLP requirements, criteria and pitfalls will be presented including some practical examples job description, training programs, QA inspections, management of test items, set-up of procedures, etc;
  3. Each afternoon session: individual exercises and group case studies on the elements presented at the morning sessions
  4. Final questionnaire to evaluate the progress of knowledge and understanding of GLP Principles  of the participants

 

Trainer

Mr. Hedwig Beernaert

    Mr. Hedwig Beernaert

    Belgian GLP expert, consultant, GM of EuroQAM

Mr. Hedwig Beernaert is the quintessential GLP expert, author or coauthor of some 100 peer reviewed publications, Chairman of the EU’s mutual joint visit program steering group, organizer and developer of multiple GLP courses and vice president of Belgium’s GLP accreditation board are just a taste of the accolades that decorate his outstanding career.

 

During his 20 year tenure, Mr. Beernaert racked up an impressive list of achievements specifically relating to implementation of OECD principles of GLP, and personally was involved in more than 200 OECD sanctioned inspections. Globally renowned as an expert in the field of OECD GLP, Mr. Beernaert started his own consultancy firm “EuroQAM” in 2009, providing quality and dependable advice and consultancy on all things GLP.

 

Target Group

  • Sponsor
  • Management
  • Study Director
  • Study Personnel
  • Principal Investigator
  • Quality Assurance Unit (QAU)

 

The course will be delivered in English

Interaction between trainer and trainees should be maximized to make the training successful

 

How to Register

Please send back the application form for seat reservation via contact@chemlinked.com
Registration Fee: 9,800 RMB for 5 days’ training (excluding accommodation, contact us for hotel reservation if necessary)