Resume/CV: Ing. Leo van den Besselaar

Size: px
Start display at page:

Download "Resume/CV: Ing. Leo van den Besselaar"

Transcription

1 Resume/CV: Ing. Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12, 1963 Home or correspondence address Street and number : Van Leeuwenhoeklaan 16 Postcode : 5252 CC City: Vlijmen Country : The Netherlands Tel. No. : +31(0) Mobile Phone no. : +31(0) Business details Part-time job (50%) TüV Rheinland Name of Organisation TüV Rheinland Nederland BV Address PO Box 541 Postcode : 7300 AM City: Apeldoorn Country: The Netherlands Tel. no. : +31(0) Fax no. : +31(0) Mobile Phone no. : +31(0) Part-time job, my own 1 st consultancy office Name of Organisation LBQ Address Street and number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Tel. no. : +31(0) Mobile Phone no. : +31(0) Part-time job, my own 2 nd consultancy office Name of Organisation GMP TopConsult BV Address Street and number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Tel. no. : +31(0) Mobile Phone no. : +31(0) CV-LvdB Page 1 of 6

2 Academic and Technical Qualifications Year Award Course Qualifying authority Yes Intermediate Vocational Education Analytical Chemistry Yes Higher Vocational Education Analytical Chemistry High School Eindhoven High School West Brabant 1999 Yes Total Quality Management High School West Brabant (Auditor) Year Award Course Qualifying authority 1998 Yes Internal Auditing I Dutch Normalisation Institute (NEN) 1998 Yes Internal Auditing II Dutch Normalisation Institute (NEN) 1998 Yes GMP Compliance auditing Pharmaceutical Compliance Associates, Stockholm 1999 Yes Internal auditing ISO 9001 High School West Brabant 2001 Yes ISO 9001:2000 Series Auditor / Lead Auditor Course BVQI 2003 Yes GMP Feed PDV Yes IRCA QMS Lead Auditor IRCA, Registration number NA Lean Six Sigma TNO Management Consultants 2008 Yes Lead Auditor IKM 3000, complaint management Foundation IKM Yes 3 Day GMP Conference Pharmatech 2009 NA Chain Management TNO Management Consultants 2010 Yes Integration OHSAS and ISO 9001 Dutch Normalisation Institute (NEN) 2010 Yes 3 Day GMP Conference Pharmatech 2010 Yes Social Responsibility ISO Dutch Normalisation Institute (NEN) CV-LvdB Page 2 of 6

3 Work Experience Year Job Title Company Chemical Analyst Diosynth BV (Akzo Nobel) Team leader Analytical Methodology Diosynth BV (Akzo Nobel) QC Manager Diosynth BV (Akzo Nobel) Quality Auditor Diosynth BV (Akzo Nobel) Quality System Manager Diosynth BV (Akzo Nobel) International Quality System Manager Diosynth BV (Akzo Nobel) Global QHSE Manager API-manufacturing Organon NV (Akzo Nobel) Interim Business Unit Manager TNO Certification BV Lead Auditor System Certification TNO Certification BV to day Lead Auditor System Certification TüV Rheinland Nederland Work Experience as consultant Year Job Title Company Certification Auditor ISO-9001, ISO-22000, HACCP, BRC, GMP-Feedsafety TNO Certification BV Certification Auditor GMP-Feedsafety KIWA Certification Supplier auditor pharmaceutical industry SQA Services (USA) to-day Consultant Quality Management & Audits LBQ to day Managing Director / Consultant GMP TopConsult BV to day Trainer Internal Auditing NEN to day Trainer Laboratory Management Avans High School Specific Auditing Experience - Internal audits I performed around the 40 internal audits within Diosynth BV covering all kinds of departments and activities. - I performed around the 100 supplier audits covering all kinds of products and services: contract laboratories, API-manufacturers, solvents, chemicals, equipment. - Guidance of customer audits For Diosynth BV I guided around the 50 customer audits for customers buying Biochemical, Chemical and Biotechnological API s. - Guidance of GMP inspections For Diosynth BV I guided 15 GMP inspections: - FDA inspections within Diosynth BV in the Netherlands and Diosynth SA in France. - MHRA inspection within Diosynth Ltd in Scotland. - Inspections of the Dutch authorities within Diosynth BV in the Netherlands. - Certification Audits - I performed around the 250 ISO-9001 / ISO / HACCP / BRC audits on behalf of TNO-Certification and TüV Rheinland Nederland BV. - I performed around the 70 GMP-Feedsafety audits on behalf of KIWA-Certification within the Feed-industry. CV-LvdB Page 3 of 6

4 References LBQ / GMP TopConsult Company Abalco Service Akzo Nobel Chemicals Avans High School Banner Pharmacaps Budelpack CML Europe FAMAR Nederland GlaxoSmithKline Janssen Animal Health Innogenetics Magma IT Solutions MSD Mondial Pack NEN Nutrilab Organon NV Pharma Consulting & Industries Pharmaceutical Services Pharmatech Peter Greven Schering-Plough Schouten SQA Services Van de Wiel Beveiliging Van Loosbroek Farma Consult Van Meeuwen Activity Internal audits / training / internal audits Internal audits / internal audits Interim Management CV-LvdB Page 4 of 6

5 An overview of the performed Supplier Audits Company Country Product Chimica Sintetica Spain Active Pharmaceutical Ingredients Diosynth BR Brazil Active Pharmaceutical Ingredients Diosynth Inc USA Active Pharmaceutical Ingredients Diosynth LTD Scotland Active Pharmaceutical Ingredients Diosynth SA France Active Pharmaceutical Ingredients Euticals S.p.A. Italy Active Pharmaceutical Ingredients Finaf-92 Spain Active Pharmaceutical Ingredients Heumann Germany Active Pharmaceutical Ingredients Moehs SA Spain Active Pharmaceutical Ingredients Sanofi-Synthelabo France Active Pharmaceutical Ingredients SelocFrance France Active Pharmaceutical Ingredients Sifa Ltd Ireland Active Pharmaceutical Ingredients Sun Pharmaceuticals India Active Pharmaceutical Ingredients Bruno Bock Germany Acids Dex Plastomers The Netherlands Polymers DSM/DSI The Netherlands Pharmaceutical Intermediates Life Technologies Scotland Cell Cultures Linde Gas Benelux The Netherlands Liquid Gasses Miavit GmbH Germany Food & Feed Merck KGaA Germany Chemicals Protexin England Food & Feed PVS Chemicals Belgium Acids Analytico The Netherlands Contract Laboratory MTL Scotland Contract Laboratory Organon Teknika The Netherlands Contract Laboratory Saybolt Nederland BV The Netherlands Contract Laboratory SGS The Netherlands Contract Laboratory BASF Germany Solvents DOW Deutschland GmbH Germany Solvents Helm AG Germany Solvents Heybroek The Netherlands Solvents Univar Belgium Solvents Methanex Europe Belgium Solvents Methanor The Netherlands Solvents Alloga The Netherlands Storage & Distribution (Pharmaceuticals) Caldic Europoort BV The Netherlands Storage & Distribution (Solvents) Organon The Netherlands Storage & Distribution (Pharmaceuticals) Vopak The Netherlands Storage & Distribution (Solvents) ATMI Packaging Belgium Packaging Materials Bünder Glass Germany Injection Cartridges Foxboro The Netherlands Computer Systems PCLD Deventer The Netherlands Contract Manufacturing Octavius Hunt England Smoke Generators Pierre Guerin France Process Equipment CV-LvdB Page 5 of 6

6 CV-LvdB Page 6 of 6

van den Besselaar Mobile Phone no. : +31(0) 653796401 E-mail: leo.besselaar@lbqconsultancy.nl

van den Besselaar Mobile Phone no. : +31(0) 653796401 E-mail: leo.besselaar@lbqconsultancy.nl Resume/CV Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12, 1963

More information

1999 Yes Total Quality Management High School West Brabant. Year Award Course Qualifying authority

1999 Yes Total Quality Management High School West Brabant. Year Award Course Qualifying authority Resume/CV Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12, 1963

More information

How companies leverage quality and quality certifications to achieve competitive advantage

How companies leverage quality and quality certifications to achieve competitive advantage How companies leverage quality and quality certifications to achieve competitive advantage Eize de Boer Systems & Services Certification International Business Development Manager Pharma Supply Chain for

More information

GMP Pharma BV. Netherlands

GMP Pharma BV. Netherlands GMP Pharma BV Netherlands Connecting the European & Indian Pharmaceutical, Biotechnology and Biopharmaceutical Industry for parallel growth and solicitation. About Us: GMP Pharma BV is a multisource organization

More information

2015 SGS MALAYSIA PUBLIC TRAINING SCHEDULE

2015 SGS MALAYSIA PUBLIC TRAINING SCHEDULE SGS Always 2015 SGS MALAYSIA PUBLIC TRAINING SCHEDULE Provide experts who are real practitioners in their professional fields as tutors and facilitators. We constantly review, monitor and evaluate our

More information

Pivot Park Screening Centre participates in novel 196 million pan-european drug discovery platform

Pivot Park Screening Centre participates in novel 196 million pan-european drug discovery platform PRESS RELEASE Pivot Park Screening Centre participates in novel 196 million pan-european drug discovery platform Pivot Park Screening Centre in Oss will play an important role in a new pan-european drug

More information

Audit Report in the framework of the APIC Audit Programme

Audit Report in the framework of the APIC Audit Programme Audit Report in the framework of the APIC Audit Programme Company Location Address Country Subject of Audit Audit Date Auditor (lead) Co-Auditor(s) Participants Signature of Auditor(s) Lead Auditor Co-Auditor

More information

Unilever Supplier Qualification System (USQS) PI Supplier Information Pack SQA Audit

Unilever Supplier Qualification System (USQS) PI Supplier Information Pack SQA Audit Unilever Supplier Qualification System (USQS) PI Supplier Information Pack SQA Audit July 2013 Table of Contents Introduction... 2 Booking Your Quality Audit... 3 Step 1. Selecting your Audit House...

More information

A Workshop Case Study for API Lead Auditors

A Workshop Case Study for API Lead Auditors This is not just a training course but a comprehensive case study! Step 1 Prepare for the Audit ECA Step 2 The Opening Meeting at API Pharma Step 3 Performing the Audit at API Pharma Step 4 The Closing

More information

GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors

GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors GRADUATE CERTIFICATE IN GOOD MANUFACTURING PRACTICE (GMP) Plan your career for tomorrow and you will be ahead of your competitors This course is a distance-learning program that will culminate in a Graduate

More information

TÜV AUSTRIA CERT GMBH. Your partner for certifications and operational safety

TÜV AUSTRIA CERT GMBH. Your partner for certifications and operational safety TÜV AUSTRIA CERT GMBH Your partner for certifications and operational safety Independent quality certification and legal security from a single source Certificates as objective proof of quality, legal

More information

Your 4 th Emergency Service. Case Studies and Experience of Others

Your 4 th Emergency Service. Case Studies and Experience of Others Your 4 th Emergency Service Case Studies and Experience of Others Preparing for 2015 and beyond Where do we invest? Prevention and appraisal costs or failure costs? (BS6143) 2 Invest before it goes wrong

More information

GMP and QMS Regulation in Japan

GMP and QMS Regulation in Japan GMP and QMS Regulation in Japan Tomiko Tawaragi Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA) August 2 nd, 2014 1 st Brazil-Japan Seminar GMP/QMS GMP : Good Manufacture Practice

More information

Custom Synthesis. Reliable, Flexible and Competitive THE KEY SOLUTION PROVIDER A FINE CHEMICAL COMPANY. About ISOCHEM

Custom Synthesis. Reliable, Flexible and Competitive THE KEY SOLUTION PROVIDER A FINE CHEMICAL COMPANY. About ISOCHEM Custom Synthesis Reliable, Flexible and Competitive About ISOCHEM ISOCHEM manufactures products and offers services that meet the most recent and stringent regulatory standards of the Pharmaceutical industry.

More information

Contamination Control

Contamination Control This course will provide practice-oriented guidance and includes practical workshops and case studies Contamination Control Microbial Contamination Sources/Preventive Measures/ Disinfection Management

More information

Europe Pradaxa Market Report 2016

Europe Pradaxa Market Report 2016 Report Information More information from: https://www.wiseguyreports.com/reports/650908 Europe Pradaxa Market Report 2016 Report / Search Code: WGR650908 Publish Date: 22 September, 2016 Price 1-user PDF

More information

Elastomeric Closures for Injections

Elastomeric Closures for Injections Elastomeric Closures for Injections Including a visit to the production plant of Datwyler in Alken, Belgium Image: Datwyler Pharma 26-27 June 2013, Brussels, Belgium SPEAKERS: Dr Piet Christiaens Toxikon

More information

NSF International. A Global Leader in Public Health and Safety. EXCiPACT TM and (Draft) ANSI/NSF 363 : Perspective on a Global Excipient Certification

NSF International. A Global Leader in Public Health and Safety. EXCiPACT TM and (Draft) ANSI/NSF 363 : Perspective on a Global Excipient Certification NSF International A Global Leader in Public Health and Safety EXCiPACT TM and (Draft) ANSI/NSF 363 : Perspective on a Global Excipient Certification Koen Bontinck Corporate Vice President San Juan April

More information

Training services that add value

Training services that add value Training services that add value Your knowledge partner in training, certification & qualification. TÜV SÜD South Asia Training that adds value with certainty in knowledge The global shift towards a knowledge

More information

Providing Trusted and Innovative Solutions t o the Life Science Communities

Providing Trusted and Innovative Solutions t o the Life Science Communities Providing Trusted and Innovative Solutions t o the Life Science Communities Eurogentec Eurogentec is a leading supplier of trusted and innovative reagents, kits, specialty products and custom research/development

More information

TRAINING PROSPECTUS 2013

TRAINING PROSPECTUS 2013 TRAINING PROSPECTUS 2013 INTRODUCTION SGS is the global leader in Inspection, verification and certification. To reap the full benefits of systems certification and to add value to your products and processes,

More information

FAMI-QS Certification Rules for Operators. Rules for Operators

FAMI-QS Certification Rules for Operators. Rules for Operators Rules for Operators TABLE OF CONTENTS 1. Application for certification and FAMI QS associate membership...2 2. Assessment of operators...3 2.1. Audit planning...3 2.2. Frequency of audits and re certification...5

More information

Quality Management System Sigma-Aldrich Buchs Overview

Quality Management System Sigma-Aldrich Buchs Overview Sigma-Aldrich Production GmbH Industriestrasse 25 Postfach CH-9471 Buchs / Schweiz Tel. +41 / 81 755 25 11 Fax +41 / 81 756 54 49 fluka@sial.com Quality Management System Sigma-Aldrich Buchs Overview This

More information

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry CLEANING VALIDATION Instructors Loh Kean Chong Rick Ng Date and Time

More information

Roche Finance Europe B.V. - Financial Statements 2013

Roche Finance Europe B.V. - Financial Statements 2013 Roche Finance Europe B.V. - Financial Statements 2013 0 Financial Statements 2011 Roche Finance Europe B.V. Management Report 1. Review of the year ended 31 December 2013 General Roche Finance Europe B.V.,

More information

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au

Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205. www.schweppesaustralia.com.au Schweppes Australia Head Office Level 5, 111 Cecil Street South Melbourne Victoria 3205 www.schweppesaustralia.com.au Quality Management Systems 1. Quality Management Systems develop, implement, verify

More information

BRC Food Safety and Quality Management System. New Issue 7

BRC Food Safety and Quality Management System. New Issue 7 New Issue 7 This is an ideal package for Food Manufacturers looking to meet BRC Global Standard for Food Safety (Issue 7 2015) for Food Safety Quality Management Systems. Our BRC Food Safety Quality Management

More information

Food Safety and Quality Management System

Food Safety and Quality Management System Introduction The company has planned, established, documented and implemented a food safety and quality management system for the site, which is maintained in order to continually improve its effectiveness

More information

Certification of management systems

Certification of management systems Certification of management systems A clear commitment to quality TÜV AUSTRIA CERT Certification of management systems: focus on continuous improvement These days, management systems are even more vital

More information

The Quality System for Drugs in Germany

The Quality System for Drugs in Germany The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute

More information

Indicative Training Catalogue

Indicative Training Catalogue You expect Added Value.not just one more boring seminar! Εκπαίδευση Training Ausbildung Indicative Training Catalogue ISSUE: JANUARY 2010-Α Phone: Head Office: 24 El. Venizelou Str, 153 41 Ag. Paraskevi,

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 13 May 2016 EMA/364968/2016 Procedure Management and Committees Support Active substance: desogestrel / ethinylestradiol Procedure no.: PSUSA/00000967/201509 30 Churchill Place Canary Wharf London E14

More information

APV/IPEC Europe Excipient Conference 2014

APV/IPEC Europe Excipient Conference 2014 APV/IPEC Europe Excipient Conference 2014 An update on regulatory and application developments 23 to 24 September 2014 Düsseldorf, Germany Course No. 3128 Marketing Düsseldorf Target Group This conference

More information

ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS AUDITOR/LEAD AUDITOR

ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS AUDITOR/LEAD AUDITOR Knowledge RECOGNITION Skills retention Further excellence behaviour Ability COMPETENCE QUALIFICATION ISO 9001 Training services SGS ACADEMY www.sgs.com sgs academy transforming people and businesses As

More information

sgs academy Further excellence

sgs academy Further excellence HOW CAN YOU AND YOUR BUSINESS GET THE RIGHT TRAINING TO CONTINUOUSLY DEVELOP? Knowledge transformation Skills SGS ACADEMY PHILIPPINES LEARNING AND DEVELOPMENT SOLUTIONS JULY DECEMBER 2016 sgs academy www.sgs.ph

More information

Reduce risk. Reduce cost. Raise performance.

Reduce risk. Reduce cost. Raise performance. Reduce risk. Reduce cost. Raise performance. Services for professional procurement. Be better informed, make better decisions. Procurement and supply chain risk management www.achilles.com Meeting your

More information

Rx-360 An International Pharmaceutical Supply Chain Consortium

Rx-360 An International Pharmaceutical Supply Chain Consortium Rx-360 An International Pharmaceutical Supply Chain Consortium Overview Rx-360 and the Audit Sharing Program September 2011 Rx-360 Members (Continuously updated list at www.rx-360.org) Manufacturers (24)

More information

Formic Acid Market by Types, Application & Geography - Global Trends, Forecasts to 2019

Formic Acid Market by Types, Application & Geography - Global Trends, Forecasts to 2019 Brochure More information from http://www.researchandmarkets.com/reports/2829861/ Formic Acid Market by Types, Application & Geography - Global Trends, Forecasts to 2019 Description: 'Formic Acid Market

More information

Aflatoxin Protocol Version October 2016

Aflatoxin Protocol Version October 2016 Aflatoxin Protocol Version October 2016 2 Sampling and testing of feed material The next protocol has conform Article 11.1 of GMP+ A1 General Regulations to be considered as section 2.4 of GMP+ BA4 Minimum

More information

ATM Security Training Middle East Riyadh, Saudi Arabia 23 rd & 24 th February 2013

ATM Security Training Middle East Riyadh, Saudi Arabia 23 rd & 24 th February 2013 ATM Security Training Middle East Riyadh, Saudi Arabia There are now over 2 million ATM s in use globally according to the ATM Industry Association and a recent report by RBR estimates that there will

More information

C h a r t 1 - KPNQwest Group

C h a r t 1 - KPNQwest Group C h a r t 1 - Group NV BIJLAGE / ANNEX 1 IP Services BV Services Finance BV financing moratorium: 30-05 bankruptcy: 25-09 09-2002 Assets Central Europe BV moratorium: 18-06 moratorium has ended Netherlands

More information

FSSC A Food Safety Management System

FSSC A Food Safety Management System FSSC 22000 A Food Safety Management System FSSC Harmonization Day 22 nd 23 rd October 2014 Amsterdam, The Netherlands Dr. Bizhan Pourkomailian, Director, Food Safety & Supplier Workplace Accountability

More information

Read the Questions Carefully

Read the Questions Carefully PHT. 463- (Quality Control of Pharmaceutical Dosage Forms) Midterm Exam I Dr. Ibrahim A. Alsarra s Section Part I Read the Questions Carefully TRUE OR FALSE: Indicate whether the statement is true or false

More information

Improving performance, reducing risk. Independent assurance - helping you manage food safety and sustainability risks

Improving performance, reducing risk. Independent assurance - helping you manage food safety and sustainability risks Improving performance, reducing risk Independent assurance - helping you manage food safety and sustainability risks The food industry faces rising food safety, environmental and social customer demands,

More information

Harmonizing Change Control Processes Globally

Harmonizing Change Control Processes Globally Quality & Compliance Associates, LLC Harmonizing Change Control Processes Globally President Quality & Compliance Associates, LLC When We Deal In A Global Environment, How Do We Design A System That Addresses

More information

Bureau of Standards Jamaica Quarterly Training Schedule July - September 2015

Bureau of Standards Jamaica Quarterly Training Schedule July - September 2015 Bureau of Standards Jamaica Quarterly Training Schedule July - September 2015 () The mission of the BSJ Training unit is to promote a culture of quality within the Jamaican society, by providing high and

More information

Pharmaceutical Quality Systems: US Perspective

Pharmaceutical Quality Systems: US Perspective Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical

More information

Quality Management Systems. Environmental Management Systems. Occupational Health & Safety. Information Security Management System

Quality Management Systems. Environmental Management Systems. Occupational Health & Safety. Information Security Management System Training Schedule July - December 2010 Course Descriptions Quality Management Systems IRCA ISO 9001:2008 Auditor/Lead Auditor Understanding the requirements of ISO 9001:2008 is the foundation of auditing.

More information

Public Training Schedule 2015

Public Training Schedule 2015 ISO 9001:2008 Quality Management Systems 1 2,500 12 27 (English ver.) 1 3,500 19 13 0.5 2,000 2 1 24 Internal Auditor 2 4,000 26-27 20-21 22-23 Internal Auditor (English ver.) 2 5,000 22-23 21-22 Internal

More information

European Biotech & Pharma Dr. Patrik Frei May 2014 Tokyo

European Biotech & Pharma Dr. Patrik Frei May 2014 Tokyo European Biotech & Pharma Dr. Patrik Frei May 2014 Tokyo 1 Overview 1. Venture Valuation 2. Trends in the EU Biotech & Pharma 3. Overview European Biotechs / Clusters 2 Valuation Valuation Mission Independent

More information

Agência Nacional de Vigilância Sanitária Anvisa Superintendência de Inspeção Sanitária SUINP Cooperation in Inspections Activities

Agência Nacional de Vigilância Sanitária Anvisa Superintendência de Inspeção Sanitária SUINP Cooperation in Inspections Activities Superintendência de Inspeção Sanitária SUINP Cooperation in Inspections Activities Japan, October 2015. ANVISA ANVISA was stablished by Federal Law 9.782/99. ANVISA s headquarter is located in Brasília,

More information

The Thales Group. Corporate Introduction THALES NEDERLAND B.V. PUBLIC. May. '09. ItTiN 2009 V02

The Thales Group. Corporate Introduction THALES NEDERLAND B.V. PUBLIC. May. '09. ItTiN 2009 V02 The Thales Group Corporate Introduction 1 THALES NEDERLAND B.V. THALES NEDERLAND B.V. AND/OR ITS SUPPLIERS. THIS INFORMATION CARRIER CONTAINS PROPRIETARY INFORMATION WHICH SHALL NOT BE USED, REPRODUCED

More information

Barco Limited liability company at 8500 Kortrijk, President Kennedypark 35. RCE Kortrijk with enterprise number 0473.191.041 V.A.T.

Barco Limited liability company at 8500 Kortrijk, President Kennedypark 35. RCE Kortrijk with enterprise number 0473.191.041 V.A.T. Barco Limited liability company at 8500 Kortrijk, President Kennedypark 35 RCE Kortrijk with enterprise number 0473.191.041 V.A.T.-liable VOTING RESULTS OF THE ANNUAL GENERAL MEETING OF SHAREHOLDERS HELD

More information

API Q2 Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries

API Q2 Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries API Q2 Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries A Service Providers Perspective How is API Q2 Different ISO

More information

Strategic Planning Presentation Enterprise Ireland Finance 4 Growth seminar, Cork, 10 th March 2015

Strategic Planning Presentation Enterprise Ireland Finance 4 Growth seminar, Cork, 10 th March 2015 Strategic Planning Presentation Enterprise Ireland Finance 4 Growth seminar, Cork, 10 th March 2015 Company Overview HQ in Cork with distribution hubs in Dublin & UK. 3 Divisions Chemicals, Paint and Food

More information

Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification

Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification European Compliance Academy Hamburg 26th 27th April 2010 Dr Iain Moore Certification Committee IPEC Europe

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 21 October 2015 EMA/827738/2015 Procedure Management and Committees Support Active substance: ondansetron Procedure no.: PSUSA/00002217/201502 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

More information

EU Capital Requirements Directive IV Article 89, Country by Country Reporting

EU Capital Requirements Directive IV Article 89, Country by Country Reporting EU Capital Requirements Directive IV Article 89, Country by Country Reporting 2013 Table of contents 03 Background 04 Disclosures for the year ended 31.12.13 04 Austria 04 Belgium 04 France 05 Germany

More information

We Know. You need to be certain. Every time. An NSF International Company

We Know. You need to be certain. Every time. An NSF International Company We Know. You need to be certain. Every time. An NSF International Company ScieNTiFic ANd TecHNicAl expertise NSF International is a global, independent public health and safety organization whose mission

More information

Knowledge. Further excellence. Learning & Development Solutions. sgs academy

Knowledge. Further excellence. Learning & Development Solutions. sgs academy Knowledge transformation Skills retention Further excellence behaviour enhanced performance expertise Ability HOW CAN YOU AND YOUR BUSINESS GET THE RIGHT TRAINING TO CONTINUOUSLY DEVELOP? SGS Academy Malaysia

More information

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation)

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Los Angeles, CA July 28th & 29th, 2016

More information

Curriculum Vitae. Contact information s. Education. Employments. Languages. Mobil:

Curriculum Vitae. Contact information s. Education. Employments. Languages. Mobil: Curriculum Vitae Contact information s Mobil: +45 3091 6335 E-mail: nasa@cgxp.eu Education 02.1994: M.Sc. Pharm. Royal Danish School of Pharmacy, Denmark Employments 03.2003 - GXP PharmAid, Consultant

More information

The APIC Audit Programme

The APIC Audit Programme The APIC Audit Programme Standardised Cost APIC-certified GMP Compliance A Third Party Audit Programme for API Manufactureres An Initiative of APIC in co-operation with CONCEPT HEIDELBERG A sector group

More information

22 nd May 2015. Ram M. Desai, Certification Manager / Local Product Manager - Climate Change Services (SEA-Region) - Copyright Bureau Veritas

22 nd May 2015. Ram M. Desai, Certification Manager / Local Product Manager - Climate Change Services (SEA-Region) - Copyright Bureau Veritas Energy Management Certification A way forward to Sustainable Business Launch of a series of Standards in Support of SS 50001 on Energy Management System 22 nd May 2015 Ram M. Desai, Certification Manager

More information

Data Integrity. Requirements for a GMP-compliant Data Life Cycle SPEAKERS:

Data Integrity. Requirements for a GMP-compliant Data Life Cycle SPEAKERS: Data Integrity Requirements for a GMP-compliant Data Life Cycle Comments on the new FDA Draft Guidance for Industry Data Integrity and Compliance with cgmp SPEAKERS: Bob McDowall R.D. McDowall Ltd. Karl-Heinz

More information

TRAINING TITLE: Internal Auditing Workshop (WORK-008)

TRAINING TITLE: Internal Auditing Workshop (WORK-008) TRAINING TITLE: Internal Auditing Workshop (WORK-008) OVERVIEW: GMP regulations worldwide as well as FDA and ICH guidances require that companies have in place an internal quality audit program. Auditing

More information

Experis Gas Mixtures. When accuracy, stability and reliability are a must

Experis Gas Mixtures. When accuracy, stability and reliability are a must Experis Gas Mixtures When accuracy, stability and reliability are a must Making the Difference For over 70 years, Air Products has enabled customers to become more productive, energy efficient and sustainable.

More information

NEW CHEMICAL ENTITIES

NEW CHEMICAL ENTITIES NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product

More information

Welcome to the ChemCon Company Presentation: 6 Steps to Success for our Customers!

Welcome to the ChemCon Company Presentation: 6 Steps to Success for our Customers! Welcome to the ChemCon Company Presentation: 6 Steps to Success for our Customers! The Founder s Vision 1992: Dr. Peter Gockel develops synthesis routes of future Active Pharmaceutical Ingredients at the

More information

DNA paternity and relationship testing services

DNA paternity and relationship testing services analytical quality measurement accuracy regulatory testing chemical measurement bioanalysis standards forensic testing DNA paternity and relationship testing services Contents 1 Why choose LGC to carry

More information

New Scientist/SRG Salary Survey 2013

New Scientist/SRG Salary Survey 2013 New Scientist/SRG Salary Survey 2013 Contents + Background + Objectives + Methodology + Executive Summary + Respondent Profile + Main Findings + Summary of Findings + Appendix Background & objectives +

More information

Computerised Systems in Analytical Laboratories

Computerised Systems in Analytical Laboratories ECA Certified Computer Validation Manager Course* New EU Annex 11 and Chapter 4 Requirements will be covered Computerised Systems in Analytical Laboratories Foto: DRK The Electronic Analytical GMP : Integrating

More information

BUREAU VERITAS KSA TRAINING CALENDER 2016 (Jul - Dec)

BUREAU VERITAS KSA TRAINING CALENDER 2016 (Jul - Dec) 1 2 3 4 5 6 version) - IRCA Awareness - IRCA Internal Auditing - IRCA Lead Auditor Transition - IRCA END VENUE TIMINGS DURATION LANGUAGE 24-Jul-16 28-Jul-16 Khobar 09:00 AM - 05:00 PM 5 days ENGLISH 5300

More information

Total Product Lifecycle Solutions from NSF Pharma Biotech. Experts in pharma training, consultancy, auditing and analytical testing.

Total Product Lifecycle Solutions from NSF Pharma Biotech. Experts in pharma training, consultancy, auditing and analytical testing. Total Product Lifecycle Solutions from NSF Pharma Biotech Experts in pharma training, consultancy, auditing and analytical testing www.nsf.org About Us NSF Pharma Biotech is a major global provider of

More information

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon Company profile Company profile ChemCon offers outstanding chemical services

More information

TUV HELLAS IS: COMPANY PROFILE PRESENTATION OF ACTIVITIES

TUV HELLAS IS: COMPANY PROFILE PRESENTATION OF ACTIVITIES COMPANY PROFILE PRESENTATION OF ACTIVITIES TUV HELLAS IS: Subsidiary wholly owned by TUV NORD Operating in Greece since 1987 One of the most reliable Inspection and Certification Organizations in the Country

More information

Job profile Asset manager - NL. PLY Energy Nederland B.V.

Job profile Asset manager - NL. PLY Energy Nederland B.V. Job profile Asset manager - NL PLY Energy Nederland B.V. February 2015 Job Profile Location Move abroad Job type Working hours Asset Manager The Netherlands Groningen, The Netherlands Optional, and willingness

More information

CERTIFICATE. with the organizational units/sites as listed in the annex

CERTIFICATE. with the organizational units/sites as listed in the annex CERTIFICATE This is to certify that with the organizational units/sites as listed in the annex has implemented and maintains a Quality Management System. : Development, production and sales of plastic,

More information

2Technical Support 3Formulation Development 4Proof of Concept 5 GMP Services 6Advanced Drug Delivery 1EUDRAGIT Products Evonik. Power to create.

2Technical Support 3Formulation Development 4Proof of Concept 5 GMP Services 6Advanced Drug Delivery 1EUDRAGIT Products Evonik. Power to create. GMP Services Solutions for Clinical Sample Manufacturing 1 EUDRAGIT Products 2 Technical Support 3 Formulation Development Proof of Concept 4 5 GMP Services 6 Advanced Drug Delivery Evonik. Power to create.

More information

Public trainings, In-house seminars, webinars Personal qualification on ISO 26262

Public trainings, In-house seminars, webinars Personal qualification on ISO 26262 AFSP AFSE FUNCTIONAL SAFETY AUTOMOTIVE TRAINING AND PERSONAL QUALIFICATION Public trainings, In-house seminars, webinars Personal qualification on ISO 26262 THE SGS GROUP SGS-TÜV GmbH THE EXPERTS is the

More information

Eclipse Premium VINYL

Eclipse Premium VINYL Eclipse Premium HOMOGENEOUS FLOORCOVERING VINYL > Harmonised colour range > Classic non-directional design > PUR reinforced Easy low-cost maintenance > Favourable initial cost > No additional surface treatment

More information

Shaping the futur. Together. 1 Präsentation TÜV Rheinland

Shaping the futur. Together. 1 Präsentation TÜV Rheinland Shaping the futur. Together. 1 Nearly 140 Years of Innovation. Your advantage: our experience. 2009 1872 Entrepreneurs take the initiative and set up the DÜV to ensure the safety of their manufacturing

More information

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry PROJECT MANAGEMENT: RENOVATION OF RESEARCH LABORATORY FOR CELL CULTURE

More information

Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments:

Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments: Sample SUPPLIER AUDIT REPORT Supplier / Factory Name: Address: Date of Visit: Tel: Fax: Suppliers Representative(s) : Name Position 1 2 3 Company status: Products supplied: Comments: The suppliers signature

More information

AXA Belgium Finance (NL) B.V.

AXA Belgium Finance (NL) B.V. AXA Belgium Finance (NL) B.V. interim financial statements June 30, 2009 Statutory seat: Utrecht Address: Ginnekenweg 213 4835 NA BREDA Breda, August 30, 2009 Table of contents Interim financial statements

More information

Guidance for Industry: Starting Material Supplier Management

Guidance for Industry: Starting Material Supplier Management Guidance for Industry: Starting Material Supplier Management Version 1.0 Drug Office Department of Health. Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. Selecting and

More information

Global supply chain quality improvements with certification and what can be done beyond

Global supply chain quality improvements with certification and what can be done beyond Global supply chain quality improvements with certification and what can be done beyond - TÜV Rheinland Industrie Service GmbH TÜV Rheinland: 140 years of tradition and innovation Your advantage: our experience.

More information

Triodos Bank. Business Banking change of account operator form.

Triodos Bank. Business Banking change of account operator form. Triodos Bank. Business Banking change of account operator form. This form enables you to add or remove account operators and authorised enquirers to your Triodos Bank account(s). ou can choose how these

More information

Two ways to be Unique. General Imaging

Two ways to be Unique. General Imaging Two ways to be Unique General Imaging Premium Performance and Point-of-care Ultrasound Efficient Hospital Organization In today s hospital organization, Efficiency and Productivity are of paramount importance.

More information

20-21 May 2015, Lisbon, Portugal. Highlights. Speakers:

20-21 May 2015, Lisbon, Portugal. Highlights. Speakers: Speakers: Dr Afshin Hosseiny Chair of the ECA Expert Working Group on GDP, Tabriz Consulting Comply with the new EU GDP Guideline Dr Martin Egger Pharmaserv Dr Daniel Müller GMP/GDP Inspector All participants

More information

Pharmaceuticals Production Services Boehringer Ingelheim. Our expertise in world-class contract manufacturing for your success

Pharmaceuticals Production Services Boehringer Ingelheim. Our expertise in world-class contract manufacturing for your success Pharmaceuticals Production Services Boehringer Ingelheim Our expertise in world-class contract manufacturing for your success Successful partnership Dr Wolfram Carius Head of Corporate Division Pharmaceuticals

More information

Management, Supply and Quality Assurance of Clinical Trials

Management, Supply and Quality Assurance of Clinical Trials Speakers Brigitte Bastyns Johnson&Johnson Rita Hattemer- Apostel Verdandi AG Andreas Jungk Lawfirm Jungk Helena Lindberg GCP Inspector, Swedish Medical Products Agency Dr Claudio Lorck AbbVie Dr Andreas

More information

What is your proposed tax status? (Please tick). PAYE Own Limited Company Individual UTR Number. Company No: UTR No:

What is your proposed tax status? (Please tick). PAYE Own Limited Company Individual UTR Number. Company No: UTR No: REGISTRATION PACK. is a specialist Recruitment Consultancy providing resource solutions to the Rail, Infrastructure, Construction and Engineering Sectors. Our primary objective is to help connect the right

More information

BRC/IOP A new standard for the Food Packaging Sector Siobhan Walsh Bsc., Food Supply Chain Specialist, Team BDS

BRC/IOP A new standard for the Food Packaging Sector Siobhan Walsh Bsc., Food Supply Chain Specialist, Team BDS BRC/IOP A new standard for the Food Packaging Sector Siobhan Walsh Bsc., Food Supply Chain Specialist, Team BDS Siobhan Walsh has over 12 years experience implementing a range of systems and standards

More information

Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers

Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005 Quality Management System - integrating GMP (ICH

More information

H. Ammerlaan + 31 (0)79 345 8274

H. Ammerlaan + 31 (0)79 345 8274 Informal document No. 16 (126th WP.29, 12-15 March 2002, agenda item 4.1.) UN ECE Transportdivision Secretariat - Mr. J. Jerie Palais des Nations 1211 Geneva 10 Zwitserland Transmitted by the representative

More information

SEG-A-086. Service and Support Chromatography Sum Parameters Biotechnology Mass Spectrometry Spectroscopy Software Testing Machines

SEG-A-086. Service and Support Chromatography Sum Parameters Biotechnology Mass Spectrometry Spectroscopy Software Testing Machines SEG-A-086 Service and Support Chromatography Sum Parameters Biotechnology Mass Spectrometry Spectroscopy Software Testing Machines Why Shimadzu Service and Support? Complete Peace of Mind Post-sales service

More information

For the latest information on VHP publications, visit our website: www.vanharen.net.

For the latest information on VHP publications, visit our website: www.vanharen.net. Other publications by Van Haren Publishing on IT Management Van Haren Publishing specialises in titles on Best Practices, methods and standards within IT and business management. These publications are

More information

CCP Recruitment 2015 Salary Survey

CCP Recruitment 2015 Salary Survey CCP Recruitment 2015 Salary Survey Technical & Engineering 2 Pharmaceutical & Medical Devices 3 Accountancy Industry & Support 4 Office Administration 4 Human Resources & Training 5 Supply Chain 6 Information

More information

Brand Quality with Asian Advantages

Brand Quality with Asian Advantages Brand Quality with Asian Advantages ScinoPharm Taiwan, Ltd. No.1, Nan-Ke 8th Road, Tainan Science Park, Shan-Hua, Tainan, 74144, Taiwan TEL : 886-6-505-2888 FAX : 886-6-505-2898 Email Contact : mkt@scinopharm.com

More information