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 Address Street / number : Van Leeuwenhoeklaan 16 Postcode : 5252 CC City: Vlijmen Country : The Netherlands Tel. no. : +31(0)735117891 Mobile Phone no. : +31(0)653796401 E-mail: leo.besselaar@lbqconsultancy.nl Business details Owner and Consultant Name of Organisation LBQ Address Street / number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Mobile Phone no. : +31(0)653796401 E-mail: leo.besselaar@lbqconsultancy.nl Internet: www.lbqconsultancy.nl Owner and Consultant Name of Organisation GMP TopConsult Address Street / number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Mobile Phone no. : +31(0)653796401 E-mail: leo.besselaar@gmptopconsult.nl Internet: www.gmptopconsult.nl Partner and Consultant Name of Organisation MP-M Business Navigators Address Street / number: Varenmos 12 Postcode: 3904 JX City: Veenendaal Country: The Netherlands Tel. no. : +31(0)318503015 Fax no. : +31(0)318503073 Mobile Phone no. : +31(0) 653796401 E-mail: leo.van.den.besselaar@mp-m.nl Internet: www.mp-m.nl CV-LvdB-01-2012 Page 1 of 6
Academic and Technical Qualifications Year Award Course Qualifying authority 1981-1983 Yes Intermediate Vocational Education Analytical Chemistry 1986-1990 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 2003-2006 Yes IRCA QMS Lead Auditor IRCA, Registration number 1183697 2008 NA Lean Six Sigma TNO Management Consultants 2008 Yes Lead Auditor IKM 3000, complaint management Foundation IKM 3000 2008 Yes 3 Day GMP Conference Pharmatech 2009 NA Chain Management TNO Management Consultants 2010 Yes Integration OHSAS 18001 and ISO 9001 Dutch Normalisation Institute (NEN) 2010 Yes 3 Day GMP Conference Pharmatech 2010 Yes Social Responsibility ISO 26000 Dutch Normalisation Institute (NEN) 2011 Yes Risk Management ISO 31000 Dutch Normalisation Institute (NEN) 2011 Yes Cosmetics GMP ISO 22716 SGS CV-LvdB-01-2012 Page 2 of 6
Specific knowledge of Standard and Guidelines Standard / Guideline ISO 13485 ISO 22716 EFfCI EXCIPACT TM IPEC ICH Q7 ICH Q10 Standard / Guideline ISO 22000 HACCP EFMC Standard / Guideline ISO 9001 ISO 9004 ISO 14001 ISO 17025 OHSAS 18001 ISO 26000 ISO 31000 Medical Devices / Cosmetics / Pharmaceuticals Medical Devices Cosmetics Good Manufacturing Practices GMP Guide for Cosmetic Ingredients Pharmaceutical Excipients : GMP and GDP Good Manufacturing Practices Guide for Pharmaceutical Excipients Active Pharmaceutical Ingredients Good Manufacturing Practices Pharmaceutical Quality System Food & Feed Safety Food Safety Management Systems Food Safety Management Systems European Feed Manufacturers Guide Sundries Quality Management Systems Managing for sustained success of an organization Environmental Management Systems Testing & Calibration Laboratories Management Systems Occupational Health & Safety Management Systems Social Responsibility Risk Management Systems Work Experience Year Job Title Company 1985-1988 Chemical Analyst Diosynth BV (Akzo Nobel) 1988-1992 Team leader Analytical Methodology Diosynth BV (Akzo Nobel) 1992-1998 QC Manager Diosynth BV (Akzo Nobel) 1998-1999 Quality Auditor Diosynth BV (Akzo Nobel) 1999-2002 Quality System Manager Diosynth BV (Akzo Nobel) 2002-2004 International Quality System Manager Diosynth BV (Akzo Nobel) 2004-2005 Global QHSE Manager API-manufacturing Organon NV (Akzo Nobel) 2005-2006 Interim Business Unit Manager TNO Certification BV 2006-2008 Lead Auditor System Certification TNO Certification BV 2009-2011 Lead Auditor System Certification ISO 9001, ISO22000, HACCP TüV Rheinland Nederland CV-LvdB-01-2012 Page 3 of 6
Work Experience as consultant Year Job Title Company 2003- to-day Owner and Consultant LBQ 2005- to day Owner and Consultant GMP TopConsult 2005- to day Trainer Internal Auditing NEN 2008- to day Trainer Laboratory Management Systems Avans High School 2012- to day Partner and Consultant MP-M Business Navigators Specific Auditing en Inspection Experience Type of audits/inspections Internal audits System Certification Audits Customer Audits GMP Inspections Activities Performance of ± 100 internal audits within different kind of companies Performance of ± 100 supplier audits covering all kinds of products and services: contract laboratories, cosmetic and API-manufacturers, solvents, chemicals, equipment Performance of ± 400 system certification audits based on ISO 9001,ISO 22000 and HACCP, ISO 22716, GMP+ Feed Safety Guidance of ± 50 customer audits for customers of Diosynth BV buying Biochemical, Chemical and Biotechnological API s Guidance of 15 GMP inspections for Diosynth BV: - FDA inspections 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. CV-LvdB-01-2012 Page 4 of 6
References LBQ / GMP TopConsult Company Activity Abalco Service Akzo Nobel Chemicals Avans High School Banner Pharmacaps Brabant Plant Budelpack CBF / internal audits CML Europe Eli Lilly FAMAR Nederland GlaxoSmithKline Janssen Animal Health Innogenetics Internal audits / training / FDA project KIWA Certification System Certification GMP+ Feed Safety Magma IT Solutions Medic MSD Mondial Pack NEN Nestlé Nutrition / FDA project Nutrilab / internal audits Organon NV Pharma Consulting & Industries Pharmaceutical Services Pharmatech Peter Greven Red Swan Schering-Plough Schouten Internal audits SQA Services SGS / System Certification ISO 22716 TüV Rheinland Nederland System Certification ISO 9001, ISO 22000, HACCP United Drug Packaging Group Van de Wiel Beveiliging / internal audits Van Loosbroek Farma Consult Van Meeuwen Interim Management Vion Food Group - SONAC / FDA project CV-LvdB-01-2012 Page 5 of 6
Examples 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 Miavit GmbH Germany Animal Health Products Protexin Ltd England Animal Health Products Provimi Lld England Animal Health Products VTA GmbH Germany Cosmetic 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 Merck KGaA Germany Chemicals 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-01-2012 Page 6 of 6