Our Lead Consultants
Head of the Valicare site in Frankfurt am Main and your GMP expert for challenging consulting projects
Dr. rer. nat. Hans-Georg Eckert, Biologist
Senior GMP Consultant / Project Manager & GMP Auditor
> 20 years of professional experience and GMP consulting in the pharmaceutical and biotechnological industry
- Specialized on GMP requirements and problem solving in the pharmaceutical and biotechnology industry with more than 100 successfully completed consulting and compliance projects
- With special focus on GMP-compliant manufacturing of ATMPs(advanced therapy medicinal products) since 1997
- Formerly Head of Production (acc. to § 15 AMG/acc. to §. 12, para 1, sentence 3 AMWVH and EU GMP Guideline Part I, 2.7), Project Manager as person in charge of the Genetic Engineering Safety Ordinance (§ 15 GenTSV), holder of a permit to handle pathogenic substances (acc. to § 44 lfSG, incl. organisms with BSL 3 ** classification) and person in charge of pharmacovigilance
- More than 70 congress contributions as speaker and organizer
Core competencies: GMP consulting, concepts and solutions, project and quality management, execution of GMP audits, GAP analyses and GMP trainings
Leader of the expert team for qualification and validation projects and your GMP expert for audits
Eng. Mohsen Masoumi (Mechanical Engineering)
Senior GMP Consultant / Project Manager & APIC- Certified Third Party Auditor
> 30 years of professional experience in the pharmaceutical and chemical industry
- Planning, design, qualification and validation of GMP-compliant pharmaceutical equipment and facilities
- Execution of projects for the manufacturing of liquid, semi-solid and solid pharmaceuticals as well as sterile products in Germany and internationally
- Management of major projects in Germany and Asia, responsible for the complete GMP implementation up to the final GMP certification of authorities
- More than 100 GMP/quality audits worldwide and more than 300 qualification projects in pharmaceutical and chemical production: manufacturing, qualification and validation of finished pharmaceuticals, APIs, excipients, and food and feed
Core competencies: GMP consulting, project management qualification & validation, execution of GMP audits, GAP analyses and GMP trainings
Leader of the pharmaceutical quality systems & ATMP team. Your expert for the transfer into GMP standard.
Dr. rer. nat. Claudia Papewalis (Biologist)
Senior GMP Consultant / Project Manager, GMP & ISO 9001 Auditor & Quality Manager
24 years in cancer research and cell therapy and > 20 years of GMP experience with a focus on cell and gene therapy
- Expert for pharmaceutical quality systems, deviation and change management, risk management, self-inspection, batch record review, GMP-compliant pharmaceutical processes, sterile pharmaceuticals
- 9 years as production manager in cell therapy (acc. to Art.12 para 1, sentence 3 German AMWVH/EU-GMP Guideline Part I, incl. the application of manufacturing authorizations)
- Since 2016, responsible for >100 successfully completed GMP projects with focus on ATMPs
- Specialized on the implementation of GMP requirements for ATMP manufacturer and consulting and support from development to approval
- 38 scientific publications
Core competencies: Project- and quality management, pharmaceutical quality assurance systems, special GMP consulting on ATMPs, project and quality management, performance of GMP and ISO compliance audits and GMP training courses
