Bernard Plau2018-09-12T14:37:06+00:00

Bernard Plau, PhD

CEO, Senior Consultant

As Akovia Consulting’s CEO and experienced Quality expert, Bernard brings a highly valuable input in guiding client to achieve their goals in compliance with pharmaceutical requirements and regulations. 

  • Akovia Consulting CEO & Scientific Director
  • Pharmaceutical Industry Quality & Process Expert
  • Chemistry R&D Expert
  • Ph.D. from the University of East Anglia (Norwich, UK)

About Bernard

Bernard is a chemist by training, graduated from Paris School of Chemistry. He then specialized in organic synthesis and got a Ph.D. from the University of Norwich (UK). After ten years as a discovery scientist and then five years in pharmaceutical development, he was offered a position as Site Quality Director and began a long career involved in GMP compliance for the manufacture and control of both active pharmaceuticals and drug products.

Bernard has been contributing to many patents and scientific publications and has a strong belief in good science as the necessary foundation for good quality. He was the recipient of awards for his scientific contribution and quality problem solving.

Thus for over 25 years Bernard has been involved in quality issues related to GMP, including being responsible for a large number of regulatory inspections, particularly FDA investigations where he has an exceptionally extensive expertise. Bernard was involved in many facets of Quality issues such as computer system implementation and prepared many seminars and lectures.

When he left the industry he was Corporate Director Quality for Sanofi-Aventis and has always volunteered in the promotion of Quality.

Work Experience

CEO and Scientific Director (2015)
  • Drug Product and API cGMP expert auditor and trainer
GMP / Process Expert (2011-2015)
  • Leaves sanofi in an early retirement plan (March 2011)
  • Participates to Associations (like ECTI, OTECI or Proqualliance) to train, audit & share
Quality Director for Chemical Syntheses for France & Hungary (2004-2011)
  • Manages Quality issues for 8 industrial sites manufacturing 175 different APIs
  • Passes more than 40 Regulatory Inspections (FDA, AFSSaPS, PMDA) with No or Minor Observations (including Biotech)
  • Trains industrial site personnel to ICHQ7, Validation, FDA Inspections
  • Participates to the organizing committee of SFSTP
  • Leads the implementation of an IS CAPA system
  • Leads in several quality topics (e.g. cleaning of equipment in API manufacturing, auditing, preparation to regulatory Inspections)
  • Contributes to joined analytical studies with Universities
  • Performs Supplier Quality Audits in many countries (mainly Asia, Americas)
  • Contributes to the improvement of complex production processes (won the 2011 sanofi-aventis Industrial Affairs Award for Innovation
Quality Director for APIs for France & Singapore (2001-2004)
  • Manages directly the Quality Operations (i.e. 300 FTEs) of 8 industrial sites manufacturing 140 different APIs
  • Creates a Site Analytical Support laboratory (20 FTEs) aimed at the validation of analytical methods, Low Molecular Weight Heparin & Taxoid counterfeits, Heparin sources differentiation
  • Starts-up an eCAPA software (9 industrial sites connected – 900 users)
  • Performs training at IFIS for the Pharmaceutical Sector
Quality Manager for Vitry, Villeneuve-la-Garenne, Le-Mans & Ploermel (1999-2001)
  • Manages Quality Operations of 40 different APIs
  • Creates the function “Regulatory Site Officer”
Quality Manager for New Projects (1996-1998)
  • Follows-up of New Projects (Phase III) to prepare PAIs both for DP & APIs
  • Prepares several PAIs (Docetaxel, Synercid)
Head of Research Laboratory (1986-1989)
  • Contributes to the selection of an NCE (RP60180) for Phase I project
  • Participates to molecular modelling of opiate derivatives
  • Builds the first data base for structure activity relationship
  • Optimizes a family of Phenothiazines as kappa agonists – 4 patents
Medicinal Chemist (1980-1985)
  • Designs several new molecular entities – 8 patents – 1 publication
  • Participates to the optimization of 3rd generation thiovinyl cephalosporins
  • Achieves the synthesis of oxacephalosporin derivatives (25 steps) for patent purposes

Expertise

  • GMP, GLP
  • Process development
  • Equipment qualification
  • CAPA system
  • Quality control
  • Validation methodology
  • Life cycle management
  • Regulatory documentation
  • HAP Quality & HSE constraints
  • Has been responsible for a large number of regulatory inspections by FDA and other agencies
  • Lead a worldwide IT CAPA project
  • Prepared many seminars and lectures about Quality in the Pharma industry (GMPs, ICH guidelines, FDA inspection, API manufacturing, Supplier audits, Risk management, HAP, Critical Parameters…)

Education

  • Ph.D. from the University of East Anglia (Norwich, UK)
  • M.Sc. from the University of East Anglia (Norwich, UK)
  • Engineer School diploma at ENSCP ParisTech*, Paris, Fr. (*École Nationale Supérieure de Chimie de Paris, a graduate school of chemical science and engineering)

Published Work