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Our Lead Consultants
Our Lead Consultants

GMP experts for pharma and biotech

Our lead consultants have long-term experience in consulting, audits, and training for GMP services as well as qualification and validation.

Head of the Valicare site in Frankfurt am Main and your GMP expert for challenging consulting projects

Dr. rer. nat. Hans-Georg Eckert (Biologist)

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 (Chemiker)

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)

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 Medical Devices (MDs) and Combinational products and your expert for regulatory compliance consultation

Dr. rer. medic. Christopher Spiegel (Biotechnology)

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)

Free first consultation now!

Free first consultation now!

 

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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Our customers are also interested in:

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.