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Guy DUCHENE

STERREBEEK

En résumé

PhD in Organic Chemistry and 30+ years experience within the international pharmaceutical industry:

- in process development and industrialization of APIs in the context of American and European standards;

- in technology transfers towards international companies specialized in outsourcing;

- in audits of outsourcing companies as back-up for manufacturing according to ICH Q7A.

- in evaluation of new processes and technologies;

- in Quality Assurance: GMP coaching / Deviations and CAPA management / FDA inspection preparation / Process validation


Currently:

GMP audits of pharmaceutical companies manufacturing Active Pharmaceutical Ingredients.

Mes compétences :
Consulting
Development
GMP
Audits

Entreprises

  • J&J - APIs Validation (CPV: Continued Process Validation) - FDA

    2015 - 2015 Implémentation de directives FDA: Continued Process Validation

  • POLYPEPTIDE LABORATORIES FRANCE - GMP Consulting

    Strasbourg 2014 - 2014 FDA inspection preparation

  • TAKEDA - Technology Manager Conversion Project Brussels

    Puteaux 2012 - 2013 Total compliance in pharmaceutical manufacturing
    Tech. Transfer of major products (including process validation).

  • TAKEDA - Technology Manager Conversion Project Brussels

    Puteaux 2012 - 2013

  • Ajinomoto - OmniChem - Production Support

    2011 - 2012 FDA inspection
    APIs Production

  • GD Pharmaceuticals Consulting - Consultant

    2010 - maintenant GMP Compliance Audits of pharmaceutical companies
    Active Pharmaceutical Ingredients Production

  • GD Pharmaceuticals Consulting - PhD in Chemistry

    2009 - maintenant GMP compliance audits of outsourcing companies, manufacturing APIs for a Belgian pharmaceutical company in collaboration with CLIVAN bvba.

  • UCB sa - Chemical Process Development

    COLOMBES 1981 - 2009 2006-2009: Director, in charge of continuous chemical development of marketed molecules in the Chemical Process Development and Industrialization (CPD&I) department.
    1997-2006: Responsible for industrial process optimization in the framework of global assistance to all UCB chemical plants, in the Process and Contact Engineering (PCE) department.
    1985-1997: Chemical Development Manager, responsible for the industrialization of new UCB products and the production of new chemical entities for clinical trials (Phase 2).
    1981-1985: Associate manager in support of Chemical Production of Active Pharmaceutical Ingredients (API).

Formations

  • Université Catholique De Louvain (Louvain La Neuve)

    Louvain La Neuve 1970 - 1977 Sciences: Chimie Organique

    1968-1970: Candidatures FNDP Namur
    1970-1972: Licence Chimie
    1972-1977: Doctorat

Réseau

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