3rd Annual Reach24H OECD GLP Training Course

Date 09/26/2016-09/30/2016
Title3rd Annual Reach24H OECD GLP Training Course
OrganiserAgrochemical&Material Division(AMD Team), Reach24H Consulting Group
LocationHangzhou, China
Details

Over the last several years REACH24h has successfully hosted an annual OECD GLP Training course here in China. Over the years our course has been greeted with widespread acclaim and this year we can offer an even better course with more in-depth treatment of certain topics and an environment that promises more intimate engagement with our GLP experts.

The five-day course will explain how to implement principles of the OECD GLP and is specifically designed for laboratory personnel involved in production of test results in line with GLP standards. The course addresses the practical implementation process, documentation strategies and maintenance of a robust GLP program. A number of discussions & cases will be included to help audience understand GLP requirements associated with QC/QA/Production Control Laboratories. The number of spaces is limited to 30 and this year’s course will include plenty of opportunities for question and discussion.

The course is supplemented with a comprehensive GLP training manual, which is also an excellent reference for later usage. Certificates of completion are given to course participants upon successful completion. At the end of the course, the participants will be able to grasp the basic tenets of GLP regulations related to a number of industry sectors and understand how to implement GLP regulatory compliance requirements including:

  • Ability to document operations and activities in accordance with OECD Principles of GLP
  • Delineate the roles and responsibilities of management, study director/principal investigator, QA, archivist, and more
  • Plan and conduct a study that meets the OECD Principles of GLP
  • Effectively record study raw data
  • Complete a study report that is compliant with the OECD Principles of GLP
  • Identify requirements of the OECD Principles of GLP in relation to multi-site studies

Course Schedule

  • Date: September 26th ~ 30th, 2016 (Mon ~ Fri)
  • Time: 9:00 ~ 13:00, 14:00 ~ 18:00
  • Venue: Hua-Chen International Hotel (Hangzhou)
  • language: English

Trainers

Prof. Alejandro Daniel Lucini Millan

    Prof. Alejandro Daniel Lucini Millan

   GLP Facility Manager/Technical Director of Microquim S.A

Prof. Alejandro Lucini is GLP Facility Manager/Technical Director of Microquim S.A (Argentina). He was also the guest expert invited by the US Department of Agriculture on GLP management of agrochemical and specializes in the pesticide regulatory process in Latin American regions. He has lectured and co-organized several international workshop/symposium on the implementation of OECD GLP principles and regulatory issues of plant protection product.

Dr. Michele Cavalleri

    Dr. Michele Cavalleri

    Eurofins Biolab Italy GLP Facility Manager

Graduated in Biology is Biocidal product Business Unit Manager and GLP Facility Manager in Eurofins Biolab - Milan (Italy) part of Eurofins Scientific, a  leading international group of laboratories providing a unique range of analytical testing services to the pharmaceutical, food, environmental and chemicals industries and to governments.

In this role he has gained a significant expertise and advanced skills that ensure process excellence for GLP facilities in compliance with GLP and OECD normative. He is also member of the European Committee CEN TC 216 that establishes standardized methods of efficacy test and requirements.  He has performed several training activities organized from the Eurofins Biolab Training Center offered to the main chemical/pesticide companies in Italy and China.

The latest successful training activity was performed on May 18th 2016 in Milan as lead speaker of the international Workshop “Efficacy testing of biocidal products. Claims and protocols according to international guidelines".

Course Program

Schedule

Morning Session

Afternoon Session

Day 1

GLP: What and Why Understanding the 10 principles of the OECD GLP MAD Program

The main roles of the GLP system:

•Regulatory Authority

•Monitoring Authority

•Test Facility

•Study Director

•Principal Investigator

•GLP Quality Assurance Unit

•Test Facility Management

•Relevant Test Facility Staff

Day 2

GLP and Study Documents

Study Plan

Draft Report

Final Report

Amendments and Deviations

SOP’s

Instructive

Technical Methodologies

and Study Guidelines

Regulatory Studies:

•Phy-chemical

•Toxicity

•Eco-Toxicity

•Other

Day 3

Internal Audits and

Inspections

Discussion, examples, and

questions

Day 4

•History of GLP

•OECD GLP harmonization

•The Mutual Acceptance of Data (MAD)

•Scope of GLP compliance

•Application of GLP

•Phys-chem studies in GLP – Concept of GLP Facility

•TEST FACILITY ORGANIZATION AND PERSONNEL

•TEST ITEM CHARACTERIZATION

•Test Facility Management’s Responsibilities
•Facilities
•Apparatus, Material and Reagents
•TEST SYSTEM
•STANDARD OPERATING PROCEDURES
•PERFORMANCE OF THE STUDY
•REPORTING OF STUDY RESULTS
•STORAGE and Retention of Records and Materials

Day 5

Planning a GLP study: from contract to study plan

•Contract for GLP activities

•Sample tracking

•Study registration

•Draft GLP Study plan

• GLP Study Plan

• Contacts

Main deviations

 

•Case STUDY 1: GLP analytical method validation

•Case STUDY 2: GLP accelerated stability study

 

Target Audience

The course is designed for anyone that needs to learn about GLP regulation, including, but not limited to: QA Personnel (GLP Auditors), Study Directors, Principal Investigators, Management, Scientists, Technicians, Facilities Personnel, and Archivists, with 0-2 years or more of experience.

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 AMD@chemlinked.com

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

Further Information