Dr. Andreas B. Meier
AT A GLANCE
More than 20 years’ experience in quality management and the development of sterile pharmaceuticals
Auditor with extensive experience in preparation and support of internal and performance of external audits
Profound knowledge of European and international GMP regulations as well as ISO standards
Experienced manager with pronounced team skills and a high level of motivation and assertiveness
Strategically orientated with an excellent grasp of business-related aspects
PROFESSIONAL EXPERIENCE
01/2019 – today
Healthcare Consultant | Berlin | www.m-vm.de
Globally active consultant for consulting services in the development of sterile drugs and medical devices, quality management (GMP and ISO), qualification and validation of equipment and processes, and approval/certification (especially CMC part) in the pharmaceutical and medical device industry.
Projects and successes
- Product Development of new products of solid and sterile semisolid forms
- Development management, validation management and preparation of non-clinical registration documentation for 11/2019 drugs approved in the USA ExEm® foam
- Preparation of technical documentation for several Class IIa and Class III medical devices and management of product certification audits.
- Management and implementation of external audits in D, UK and China
- Revision of the QM handbook and entire high-level QM documentation of a medium-sized pharmaceutical manufacturer for autologous cartilage tissue.
- CAPA / deviation management for companies in the Netherlands and UK.
- Extensive process and cleaning validations at a medium-sized pharmaceutical manufacturer.
- Elemental Impurity Assessment according to ICH Q3D.
- MDR certification of material medical devices of class IIb.
- Activity as PRRC according to Article 15 MDR.
04/2013 – 12/2018
Farco-Pharma GmbH | Cologne, Germany | www.farco-pharma.de
Global provider of products for urology and outpatient medical care
Turnover of €30 million | 30 employees
Head of R&D and quality management
Responsibility: budget up to €2 million | Managerial responsibility for 6 members of staff
- Development of new products
- Continuous improvement of the existing product portfolio as well as existing
production processes - Qualification of alternative suppliers for existing and new products, components, forms of packaging, etc.
- Professional management of the development processes as well as transfer of new products to series production
- Provision of non-clinical approval documents (CMC section)
- Management and performance of internal and external audits
- Maintenance of the QM manual and the entire documentation of the QM system
- CAPA / deviation management
- Responsible support for audits performed by national and international authorities, notified bodies and customers
- Introduction of corrective measures to rectify weaknesses
- Head of vigilance / pharmacovigilance
- Safety officer for medical products
- Release / rejection of medical products as the «person responsible for regulatory compliance»
Successes:
- Successful new development of own products such as InstillaGel Hydro®, Farco-fill Protect® or Instillamed®
- Successful development of new toll-manufactured products such as Jelido® in
Canada and ExEm® in the USA including the creation of the CMC approval
documents - Development of a globally patented sterilisation process and thus avoidance of
20% of process-related off-specification batches - Successful support of five master’s degree students and one PhD student
- Invention of products, processes and recipes and corresponding patent applications
05/1996 – 03/2013
Klosterfrau Berlin GmbH | Berlin, Germany | www.klosterfrauberlin.de
Company in the self-medication market active throughout Europe | 3 employees
Quality management
Since 01/12
Head of QM / GMP compliance
Since 03/08
Professional coordination of QM / GMP compliance
Since 07/00
Validation representative
Since 07/98
Quality management representative (QMB) pursuant to ISO 9001 and 13485
- Recipe development, stability testing, optimisation of production parameters
- Development and validation of analytical processes
- Project management of FDA approval
Successes:
- Preparation, execution and successful implementation of a pre-approval inspection by the FDA within three years
- Successful development of toll manufacturing for Suprasorb G, Dianatal and Prefert
- Product development of pre-filled sterile single-use syringes including recipe optimisation
- Set-up and development of a quality management -systems for Klosterfrau Berlin GmbH
- Achieved recipe stabilisation of the main product Instillagel® after analytical clarification of causes and thus created the prerequisite for cost-effective manufacturing
- Optimisation of the analytic process, thus achieving savings up to 2017 of €1.2 million
09/1994 – 06/1995
Co-author with Prof. Dr. J. Mulzer of “Chiral Auxiliaries in Organic Synthesis”
01/1989 – 11/1994
Free University of Berlin | Berlin, Germany | www.fu-berlin.de
- Research associate and assistant in the chemistry course for medical students
- Tutor in the chemistry course for medical students
03/1985 – 05/1989
Meinungsforschungsinstitut Marplan (a polling institute) | Offenbach, Germany | www.marplan.de
Freelancer
EDUCATION
10/1982 – 09/1994
Free University of Berlin | Berlin, Germany | Studies of chemistry
- Thesis under the supervision of Prof. Dr. H. Kurreck (08/88 – 07/89)
“Synthesis of vitamin B2 derivatives and ESR/ENDOR investigation of the anion radicals in inverse micelles” - PhD under the supervision of Prof. Dr. J. Mulzer (12/89 – 09/94)
„Synthesis of homochiral proline derivatives as building blocks for peptidomimetics”
1975 – 1981
Abitur (university entrance level exams) at the Hans-Carossa-Gymnasium (secondary school) | Berlin, Germany
PUBLICATIONS
- Synthesis of Enantiopure 1,2-Didehydropyrrolidine, D-Proline, and Oxazoline Derivatives via Staudinger-Aza-Wittig Cyclisation of γ-Azido Aldehydes:
(J. Mulzer, A. Meier, Synthesis 1996, 123–132)
- Synthesis of Cis- and Trans-3-Hydroxy-D-Proline and (+)-Detoxinine:
(J. Mulzer, A. Meier, J. Org. Chem. 1996, 61, 566-572)
- Steam Sterilization of Pre-Filled and Blistered Ready-to-Use Syringes:
(A. Meier, V. Meßmer, Pharmind 2006, 11, 1318–1319)
- Steam Package – Terminal Steam Sterilization of Pre-Filled and Blistered Syringes in their Final Package, The Universe of Syringes & Injection Devices
(23–25 October 2006, Bethesda, MD: A. Meier, H. Miething)