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-Berater/-Projektmanager & GMP-Auditor
Over 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
Dr. rer. nat. Carsten Börger (Chemist)
Senior GMP Project Manager and GMP Auditor
Over 15 years of professional experience in the pharmaceutical and biotechnology industry
- Qualification and validation of GMP-compliant pharmaceutical equipment (production and quality control)
- Specialized in the validation of computerized systems (CSV), cleaning validation, method validation, the establishment and optimization of GMP systems
- Formerly Head of Production (acc. to Art. 12, para 1, sentence 3 German AMWVH and EU GMP Guideline Part II)
- More than 30 scientific publications
- More than 100 GMP projects in pharmaceutical and biotechnological production: manufacturing, qualification and validation of finished pharmaceuticals, APIs and excipients
Core competencies: GMP consulting, project and quality 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 over 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
- 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
Senior GMP Consultant - Qualification
Dr. rer. nat. Mario Ramos (Biotechnologist)
Senior GMP Consultant / Project Manager
11 years of experience in applied cell therapy (ATMPs) and over 8 years of GMP experience
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Specialized in pharmaceutical QM systems, deviation and change management, risk management, GMP-compliant pharmaceutical processes, qualification of devices and equipment, validation of analytical methods, quality control, biodecontamination
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11 years of cell therapy experience (research & teaching in academia as well as head of quality control in industry for an ATMP (§ 13 AMG) and a tissue preparation (§ 20c AMG) including the application for manufacturing licenses)
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Over 24 successfully completed GMP projects since 2019 (consulting, training, qualification / validation)
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Specialized in consulting and implementation of GMP requirements for ATMPs (development to approval)
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22 scientific publications and congress contributions
Core competencies: Pharmaceutical QM systems, risk management, GMP processes, GMP consulting on ATMPs, quality control, implementation of qualifications and validations, GMP trainings
Senior GMP Consultant - Quality Management
Dr. rer. nat. Katherina Pfister (Biologist)
Senior GMP Consultant / Project Manager and ISO 9001 Quality Manager
9 years of professional experience in quality management and GMP consulting
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Specialized in the implementation and maintenance of (pharmaceutical) quality management systems, deviation and change management, CAPA, quality risk management, self-inspections, validation, GMP-compliant pharmaceutical processes
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Involved in over 100 successfully completed GMP projects since 2016, including over 20 in a management role
Core competencies: Project and quality management, GMP consulting with a focus on ATMP, development and maintenance of quality management systems through to certification, conducting self-inspections and GMP training courses
Senior GMP Consultant - Quality Management and Qualification
Dr. rer. nat. Christiane Müller-Hagen (Biochemist)
Senior GMP Consultant / Project Manager, ISO 9001 Quality Manager and Certified Auditor (DGQ ISO 190 11)
Senior GMP consultant/project manager, ISO 9001 quality manager and certified auditor (DGQ ISO 190 11)
25 years of professional experience in the pharmaceutical and biotechnology industry, including 13 years of quality management and GMP
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Focus on the implementation and maintenance of (pharmaceutical) quality management systems, deviation and change management, CAPA, quality risk management, audits and gap analyses
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Since 2017 QMB/deputy QMB of Valicare GmbH. Preparation and implementation of internal and external audits
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Since 2013, various GMP consulting, qualification and validation projects in chemical and pharmaceutical production
Core competencies: Quality and change management, ISO compliance audits, GMP projects, qualification & validation and QM training
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News
Stay up to date with the latest developments and news from the world of Good Manufacturing Practice (GMP), Advanced Therapy Medicinal Products (ATMP) and Valicare. Our overview provides you with valuable insights to always keep you informed and competitive.
GMP Compliance
Professional GMP compliance ensures the quality of drugs and active ingredients.
Cell and Gene Therapy
ATMPs offer new, promising therapeutic approaches for diseases that were previously considered incurable. However, the regulatory requirements are challenging.
Brochures
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Our Company
Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.