5th Annual Reach24H GLP Training Course -Quality Practise for the Development and Implementation of the GLP Principles

Date 08/27/2018-08/31/2018
Title5th Annual Reach24H GLP Training Course -Quality Practise for the Development and Implementation of the GLP Principles
OrganiserAgrochemical&Material Division(AMD Team), Reach24H Consulting Group
LocationHangzhou, China
Details

The understanding, development, implementation, follow-up and improvement of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. The GLP Principles are mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals and other products as required by national regulation or legislation.

A lot of actors (sponsors, management, study directors, study personnel, quality assurance staff and archivists) are involved in the development, implementation and follow-up of a GOOD LABORATORY PRACTICE (GLP) quality system. Therefore,  correct understanding and interpretation of the content of the principles of GLP and related documents are crucial before reliable data are produced with the purpose to register or license the test items of different origin.

The programme of this GLP training course will be focussed  to

  • Introduction to GLP, application and mutual acceptance of data
  • Management responsibilities
  • Performance and reporting of GLP studies
  • Quality Assurance Program

The organization of this GLP Training Course exists of presentations, questions and answers, individual exercises and group exercise cases.

The GLP workshop is an advanced GLP training course where it is recommended that participants have a basic knowledge and experience of the GLP  Principles to follow successfully this training course
 

  • Date: Aug. 27th ~ Aug. 31st, 2018 (Mon ~ Fri)
  • Time: 8:30 ~ 12:30, 13:45 ~ 17:30
  • Language: English&Chinese
  • Venue: Hua-Chen International Hotel  (Hangzhou, China)

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

ScheduleMorning Session (8:30 ~ 12:30)Afternoon Session (13:45 ~ 17:30)
Day 1

•Introduction
•Individual exercise about the knowledge of the GLP Principles
•History of GLP
•What is GLP
•Organization and responsibilities

Individual exercises and group case studies on the elements presented at the morning sessions:

•Define the critical control points;
•Indicate the requirements of GLP which are linked with;
•Make an analysis and an action plan;
•Prepare an answer;

Day 2

•Management of facilities
•Management of test systems:
•Management of test items;
•Management of documents

Day 3

•Management of archives
•Management of apparatus, materials and reagents;
•Validation of computerized systems(life cycle, validation process validation of spreadsheets);

Day 4

•Performance of studies(study protocol, deviations, amendments and raw data)
•Reporting of study results(content, approval, statement and distribution)

Day 5

•Quality Assurance Program(Planning, preparation, performing, reporting, corrective actions and follow-ups)

Trainer

Mr. Hedwig Beernaert

    Mr. Hedwig Beernaert

    Belgian GLP expert, consultant, GM of EuroQAM

Mr. Hedwig Beernaert was during 20 year member of the OECD and EU GLP steering group and has a lot of experience with the organisation of GLP training courses. He is very interactive with the participants and requires full commitment during discussions and individual and group exercises .

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)

How to Register

Please send back the application form for seat reservation via: amdChemlinked.com

Registration Fee: 1,650 USD for 5 days’ training (excluding accommodation, contact us for hotel reservation if necessary)

 

 

Further Information