REACH24H Consulting Group

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Displaying items by tag: Chemlinked

The Most Powerful Tools in Your AP Region Especially China Regulatory Compliance Arsenal

Please click here to view more information about Chemlinked.

What is ChemLinked?

ChemLinked which boasts a multidisciplinary team of scientists, compliance specialists and language experts was created by REACH24H CONSULTING GROUP to meet the massive and largely unanswered demand for quality & dependable Asia-pacific region especially China Chemical, Food, Cosmetic and Agrochemical regulatory and compliance information.

Online Regulatory Information Services

• News

Monitor, interpret and report regulatory updates

Expert Article

In-depth interpretation, authoritative compliance guidance and extensive hands-on compliance experience

• Pedia

Wikipedia-style webpages providing all the essential regulatory info needed to ensure regulatory compliance

• Webinar

Regular webinars to deliver compliance solutions and interaction with experts

• E-translation

High-quality English translations of key regulations/standards

• List Collection

Searchable database for related lists, inventories and catalogues

• Regulatory Database

On-line library enriched with must-know regulations/standards

• Country page

One-stop webpages for regulatory information based on the country

Other Value-add Services

Advertisement Service

On-demand Translation Service

One-to-one Consultancy Service

Tailored Regulatory Report Service

Regulatory compliance is the key to the door of the AP market and where regulatory compliance and experience is concerned…ChemLinked is Key.

Published in chemlinked
Date 25-29 Aug, 14
Title OECD GLP Training Course
Organiser Chemlinked
Location Hangzhou, China
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.

Published in Webinar & Seminar

With both the world’s largest population and the largest chemical production base, the social issues and potential risks inherent in chemical production, usage and trade take on greater significance in China. To address environmental and public health concerns, the government has taken huge steps to ensure safe and sustainable growth of China’s industry. A concerted effort from both national and regional fronts to improve the joint law enforcement activities of environmental protection, public security, health care and public hygiene, has been increasingly effective. The efficacy of this increased administrative enforcement has been multiplied by an overhauled legislative framework.

The webinar has successfully concluded !!

To assist companies to understand and comply with Chinese chemical regulations, REACH24H together with Chemlinked will broadcast a free Webinar on December 4, focusing on detailed interpretation of the technical difficulties, common problems in documentation and an overview of the latest legislative updates. Presentations will be prerecorded and broadcasted in high quality format. There will then be a live Q&A session during which our regulatory experts will answer questions.

Topics
1. Compliance with MEP Order 22: Measures for the Environmental Management of Hazardous Chemicals Registration (Trial)
*key components of the regulation
*affected companies and regulated product scope
*legal liabilities
*regulatory compliance know-how

2. China New Chemical Substance Notification: Latest Developments and Notification Procedure<
*sharing of most up-to-date notification strategy
>> Interpretation of notification strategy recognized by official guide
>> Interpretation of anticipated supervision approaches and partial data requirements
>> Important issues raised by authorities, e.g. intermediate new chemical substance management, registration certificate transfer and expert review
*post-notification duty
>> Understanding post notification obligations
>> Breaking down post-notification duties including initial activity report and highlights in annual reporting work
>> Tips on compliance where standard compliance procedures are unclear
*interpretation of regular notification procedure and noteworthy points
>> procedure dissection with reference to one “First-Band Notification” case
>> risk assessment report compilation requirements in comparison with EU REACH
>> exemption conditions of special substance
>> purity requirements of test sample
>> requirements in the tests carried out in China

3. Detailed Interpretation of SDS Self-Review Practice, according to the updated GB (National Standard)
*latest update of China GHS
*introduction of new SDS compilation guidance
*analysis and suggestions to incompliant SDS compilation based on real case
*detailed interpretation of review points by authority 
·Emergence phone call issues in China and NCEC service introduction

Presenter
Linda Li

Linda Lee graduated from Zhejiang University of Technology with a master degree, majoring in Environmental engineering and Chemical engineering. She has many years’ experiences in the practice of risk assessment of environmental protection and human health, completing risk assessment report for hundreds of substances during EU REACH registration. Being an expert in various areas of chemical regulatory affairs, Linda currently focus on chemical safety assessment (EU/REACH), risk assessment of new chemical substance (China/Measure on the Environmental Management of New Chemical Substances), risk assessment of Cosmetic Raw Materials (China), etc.

Mona Zhang
Ms. Mona Zhang joined REACH24H after graduating from the Department of Chemical and Biological Engineering, Zhejiang University. Ms.Zhang attained her Master’s degree in Environmental science for the study of the polymeric membrane and has a paper published on this topic in the Journal of Membrane Science. Mona is a core member of REACH24H’s new chemical substance notification Team and has managed more than 40 cases covering all notification types. She has rich experience in the data gap analysis for the regular notification.

Eric Sun
Mr. Sun is extremely experienced in classification and labeling (C&L) and compiling safety data sheets (SDS) in compliance with the requirements of China GHS. He regularly runs training programs on China GHS and hazardous chemical regulations for the international companies such as Würth Group, Vaillant GmbH, Coloplast A/S, Cardolite Corporation. Currently his focus is on hazardous chemical regulations in China, mainly the Regulations on the Control over Safety of Hazardous Chemicals” (Decree 591).

Contact Us
Jerry Yan
Email: Jerry.yan@cn.reach24h.com
Tel: 86 (0)571 8700 7546

REACH24H
REACH24H is a consulting company specialized in providing chemical regulatory consultancy and technical solution for chemical industries around the world. We have a team of more than 90 people serving more than 4000 clients from every continent. Our global locations in China, Ireland and Canada ensure our timely response to customers’ needs.
Founded in 2009, REACH24H is dedicated to developing cost-effective and efficient compliance projects for enterprises facing the major chemical regulatory barriers worldwide, including: EU REACH, EU CLP, Global GHS, China NCSN, China pesticide, China Cosmetics, US TSCA, Japan CSCL, Korea-REACH, etc.
REACH24H collaborates with clients to help them better recognize and understand their chemical regulatory obligations before entering into a foreign market. Our extensive cooperation with governments and industry associations keep us at the forefront of the latest chemical regulatory trends.

Chemlinked
ChemLinked is a unique platform providing access to the latest regulatory developments in Chemical Management in China. It provides our customers with breaking regulatory news, access to a comprehensive and user friendly regulatory database, all backed up by a bilingual team of scientific luminaries boasting a wealth of practical and technical experience.

Published in Webinar & Seminar
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