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OECD GLP Training Course

25 Aug 2014 - 29 Aug 2014
Hangzhou, China
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Details

Chemlinked.com was launched in October 2012 by REACH24H Consulting Group to provide regulatory updates and in-depth analysis for the Chinese market. Since then, Chemlinked has become China’s premier compliance information and registration service provider with focusing on chemical regulations and safety assessments in China, Japan and South Korea. It has gained worldwide popularity among professionals in the chemical industry and has become an indispensable information and interaction platform covering the Asia-Pacific Region.

At REACH24H we are proud to invite Mr. Hedwig Beernaert, a veteran in OECD GLP with over 20 years expertise to offer training on GLP quality systems. Mr. Beernaert’s has been a constant in the world of OECD GLP and has been integrally involved in 200+ OECD sanctioned inspections.

The course is aimed at quality engineers and study personnel involved in all things GLP. The training course will provide a chance to meet one of the world’s foremost GLP experts. This training event is a rare opportunity to discuss practical issues involved in QA development, GLP implementation and preparation for GLP inspections.

The training is designed to provide participants with in depth knowledge on OECD principles of GLP. As per Mr. Beernaert suggestion the course will be limited to 20 people and take place over a period of 5-days to maximize training utility.

Course Details

  • Date: August 25th ~ 29th, 2014 (Mon ~ Fri)
  • Time: 9:00 ~ 13:00, 14:00 ~ 18:00
  • Venue: Sheraton Xixi Hotel, Hangzhou, China

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.

Training Overview & Course Schedule

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

  • Introduction
  • General GLP aspects
  • What is GLP?
  • Relationship between Receiving and Monitoring Authority
  • Scope of GLP: trends in the OECD GLP Principles
  • Legal Framework
    (Differences between OECD, USA and Japan)
  • Inspection preparation: how to survive an inspection?
  • Critical points concerning responsibilities of Sponsor
    - Test Facility Management (TFM)
    - Study Director (SD)
    - QA staff
    - Archivist
    - Study personnel
  • Master schedule of GLP studies

 

Day 2

  • Critical points QA Program
  • What is a processed based inspection?

Group exercise : performance and reporting a test facility inspection 

Day 3

  • Critical points of facilities: floor plan, separation of
    activities, environmental conditions, waste
    disposal, housekeeping
  • Critical points apparatus, materials and test
    systems: purchase, use of terms maintenance,
    calibration and validation
  • Critical points computerized systems
  • IT policy: responsibilities, training, security, SOPs, archiving
  • Master validation plan (DQ, IQ, PQ, OQ) of computerized systems

Day 4

  • Critical control points of test and reference items
  • Critical points standard operating procedures
    (SOPs)
  • Critical points archives
  • Critical points performance of a study

Day 5

  • Critical points reporting of a study

Group exercise: open discussion results case study final report

Target Group

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

The course will be conducted in English.

How to Register

Registration Fee: 9,800 RMB for 5 days’ training (excluding accommodation, contact us for hotel reservation if necessary)

To register for the course
Please send back the application form in the attachment by fax or email.

Attachment

Registered Organizations

Zhejiang Academy of Agricultural Sciences    NutriChem Beijing   CSERC Suzhou   Xishan Zhongke, Suzhou  FMC Shanghai

 Yifan Biotech   Yongnong Chemical

Shenyang Research Institute of Chemical Industry Laprode Analysis Co., Ltd.