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
Leader of the expert team for Computerized System Validation (CSV) and your CSV expert for consulting, audits, and training
Eng. Thomas W. Hoehle (Mechanical Engineering)
Senior CSV Consultant / Project Manager & CSV Auditor
Over 25 years of professional experience and senior CSV consultant in the pharmaceutical, biotechnological, and medical technical industry
- Specialized in the management of CSV projects and thus the validation of computerized systems and their supporting business and production processes in the life science industry
- Over 25 years of experience in IT, including as a software tester and test manager according to ISTQB as well as interim IT manager and head of qualification of IT infrastructures and their operation
- Specialized in quality management systems in the life science sector, including requirements management, risk management, deviation and change management
- Trainer for GAMP® 5 in the 2nd edition and CSV auditor also related to ISO 9001, ISO 13485, ISO 27001, and cyber security
Core competencies: Project, test and quality management, validation of computerized systems including their business and production processes, qualification of IT infrastructures including their operating processes, execution of CSV audits and CSV training courses
Leader of the expert team for Medical Devices (MDs) and Combinational products and your expert for regulatory compliance consultation
Dr. rer. medic. Christopher Spiegel (Biotechnology)
Senior Medical Device Consultant / Project Manager
10 years of professional experience and senior Medical Device Consultant in the pharmaceutical, biotechnological, and medical technical industry
- Specialized in MDR requirements, GAP analyses of the technical documentation of medical devices, risk management as well as writing, updating and reviewing the MDR dossier package
- 10 years of experience in the regulated industry including interim MDR expert team leader, material expert team, biocompatibility expert and life cycle manager
- Specialized in biocompatibility assessments (ISO 10993), design validation, cleanroom qualification and validation of environmental monitoring systems and automated manufacturing facilities
Core competencies: Medical device consulting, GAP analyses of technical documentation for MDR requirements, regulatory compliance, biocompatibility assessments (ISO 10993), risk management (ISO 14971)
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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.
GMP for ATMPs
ATMPs offer new, promising therapeutic approaches for diseases that were previously considered incurable. However, the regulatory requirements are challenging.
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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.