QA-/RA-Beratung für die Medizinprodukte- und Pharmaindustrie
Aktualisiert am 10.08.2021
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 17.01.2021
Verfügbar zu: 100%
davon vor Ort: 100%
Individuelle Lösungen nach Kundenbedarf
English
Able to negotiate
German
Native Speaker

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

6 Jahre 5 Monate
2019-07 - heute

Selection of periodic or ongoing projects

  • PPE technical innovations management (e. g. GRAMM medical healthcare GmbH)
  • Clean room, product and personnel monitoring for uncoated and cytostatic coated catheter production including GMP training (e. g. B. Braun Melsungen AG)
  • Consulting for the selection of personal protective equipment for the Wuhan Medical Center due to the Corona epidemic outbreak in Wuhan (China)
  • Technical processing of EU patent applications (Companies confidential)
  • CAPA management of external sterile disposables manufacturing (e. g. Brainlab AG)
  • Preparation and MDR updating of technical documentations for regulatory approval purposes incl. 510 (k) – applications (e. g. Deltacor GmbH)
  • Internal GMP- und QMS compliance audit acc. contract manufacturing of selected medical devices incl. hygiene training (e. g. WILD GmbH)
various companies
6 Monate
2019-01 - 2019-06

Spare Parts Management of Temporary Cardiopulmonary Support Systems

  • Spare parts manager of temporary cardio-pulmonary support system components incl. QC test methods verification
  • Gap analysis and investigations of hygiene management in the QC test lab incl. heater-cooler devices
LivaNova Deutschland GmbH
München
6 Monate
2018-07 - 2018-12

SME Quality Management acc. EN ISO 13485:2016

  • QMS update with risk-based approach according to the requirements of EN ISO 13485:2016; elimination of audit deviations and preparation of the re-certification audit
  • Restructuring of processes for design transfer as well as supplier qualification and assessment
JOTEC GmbH (CryoLife Inc.)
Hechingen
4 Monate
2018-03 - 2018-06

CAPA Management of Temporary Cardiopulmonary Support Systems

  • CAPA manager in the electronic operations and manufacturing department of temporary cardiopulmonary support system components
  • Root cause analysis and investigations of soldering processes and testing systems for circuit boards
LivaNova Deutschland GmbH
München
6 Monate
2017-09 - 2018-02

SME Sterile Eye & Wound Care Solutions

  • Project manager and SME for DMF remediations/revisions of sterile (single use) eye & wound care solutions including accessories and supplies (European and EMEA markets)
  • Cooperation with external contract manufacturing partners
  • Consulting and review of marketing materials including international competition analysis
First Aid Equipment Manufacturer
Germany
7 Monate
2017-01 - 2017-07

Peritoneal Dialysis Systems

International Engineering Project Manager
International Engineering Project Manager
  • Responsible project manager and team leader at Global Research & Development (GRD) for the next generation of the homecare peritoneal dialysis system including hard- and software, accessories and supplies (European and South American market)
  • Cooperation with external contract development and manufacturing partners
  • Complete documentation reviews for the technical file to fulfill all relevant regulatory requirements
Fresenius Medical Care
Bad Homburg & Schweinfurt
3 Monate
2016-07 - 2016-09

SME in International Complaint Management of Drug-Device Combination Products

  • International investigation and CAPA handling of inhaler systems for asthma therapy
  • Document & database (SAP, TrackWise etc.) management to fulfill the regulatory requirements acc. 21 CFR part 11 compliance etc.
Boehringer Ingelheim Pharma GmbH & Co. KG
Ingelheim
3 Monate
2016-02 - 2016-04

SME in GMP Readiness for Swiss Health Authority Inspections

  • Remediation of technology transfer processes (solid dosage form pharmaceuticals production relocation) acc. national and international GMP standards (incl. ICH Q7-Q10, PIC/S, EU-GMP & WHO Guidelines)
  • Remediation of cleaning validations and risk assessment related to cross contaminations acc. actual EMA requirements (PDE concept)
Acino Pharma AG
Aesch/BL
1 Jahr 3 Monate
2014-09 - 2015-11

International Customer Complaint Management

Team & Project Leader
Team & Project Leader
  • Investigations, CAPAs & technical risk assessments incl. interface to change control management for clinical (pre-analytical) laboratory automation systems according IVD Directive (Directive 98/79/EC), EN ISO 13485, EN ISO 14971 etc.
  • Handling of potential critical cases (PCCs) for the safety board of Roche Diagnostics
  • Document & database (SAP etc.) management to fulfill the regulatory requirements acc. 21 CFR part 11 compliance etc.
Roche PVT GmbH (Roche Diagnostics)
Waiblingen
6 Monate
2014-04 - 2014-09

Single & multiple use drug delivery systems

Head QA Medical Devices
Head QA Medical Devices
  • Single & multiple use drug delivery systems for injectable biopharmaceuticals (e.g. human growth hormones) and drug-device combination products
  • Management of device development reviews, risk assessments, packaging, sterilization and transport validations etc. according all international relevant standards and requirements incl. MDD (Directive 93/42/EC), EN ISO 13485, 21 CFR 820 etc.
  • Management of international device releases, deviations, complaints, CAPAs, internal & external audits incl. third parties (contract manufactures)
Sandoz GmbH (Novartis)
Kundl/Schaftenau
8 Monate
2013-08 - 2014-03

Risk assessment remediation of spine implants acc. EN ISO 14971

Senior CAPA & Risk Assessment SME Consultant
Senior CAPA & Risk Assessment SME Consultant
  • International complaint and CAPA management acc. FDA and EMEA standards, personnel training for root cause analysis techniques and risk assessment, packaging and sterilization validation
  • Continues process improvement for osteosynthesis implants and surgical instruments
  • Risk assessment remediation of spine implants acc. EN ISO 14971
DePuy Synthes (Johnson & Johnson)
Zuchwil/Oberdorf/Balsthal

Aus- und Weiterbildung

Aus- und Weiterbildung

1982 - 1989

Friedrich-Alexander-University Erlangen-Nürnberg (D)
Diplom-Physiker Univ. [Master of Science (M.Sc.) in Physics]


Aufgaben:

Basic Study in Chemistry / 1989 Thesis (Institute for Biomedical Engineering):
Investigation of the Electro reflectance and the Electrochemical Properties of n-Type Semiconducting
Oxide Electrodes on Titanium-Based Materials at the Oxide-Semiconductor/Electrolyte Interface


1975 - 1978

J. Pfrimmer + Co., Pharmaceutical Company, Erlangen (D)
Chemical Laboratory Assistant [Certificate of the Chamber of Industry and Commerce, IHK Nürnberg]


Aufgaben:

Vocational Training on Chemical Laboratory Assistant (Focus on analytical and pharmaceutical chemistry of amino acids, peptides, vitamins, carbohydrates, electrolytes etc., GMP of sterile enteral and parenteral solutions technology, Xylitol pilot plant production for astronaut food (NASA) etc., preparation of catgut and human dura mater implants with respect to the prevention of Creutzfeld Jakob disease (CJD) infections)

COURSES, CERTIFICATES, APPOINTMENTS:


03/2018

  • Certificate - Up-to-date Implementation Status of the EU Medical Device Regulation (EU MDR)
  • BVMed (MedInform) Conference, Köln (Germany)


03/2017

  • Actual Trends within the European Medical Device Regulation (EU MDR) ? MDR Implementation Recommendations ? Clinical Testing ? MDSAP
  • BVMed (MedInform) Conference, Bonn (Germany)


10/2011

  • V2011 ? Vacuum Coating and Plasma Surface Technology (Dresden)
  • EFDS ? European Society of Thin Films e. V., Dresden (Germany)


01/2011

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2011
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2010

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2010
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2009

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2009
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2008

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2008
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


11/2007

  • The Osteoblast (Würzburg)
  • Orthopedic University Clinic Würzburg, Prof. Dr. med. J. Eulert (Germany)


09/2007

  • Liability Issues for Manufacturers and Distributors of Medical Devices
  • EUROSPEC ? Institute of Equipment Safety and Quality Management, Darmstadt (Germany)


08/2007 ? 07/2010

  • Extension appointment as external medical device auditor/expert regarding EN ISO 13485 & MDD (Directive 93/42/EC)
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2007

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2007
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


11/2005

  • Tibetan Medicine for Chronic Diseases (Zürich, Switzerland)
  • University Hospital Zürich, Institute for Natural Medicine (CH), Licence: 1-222-1-05-P50


07/2004 ? 07/2007

  • Appointment as external medical device auditor/expert regarding EN ISO 13485 & MDD (Directive 93/42/EC)
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


11/2003

  • 2nd International Congress on Tibetan Medicine (Washington DC, USA)
  • Pro-Cultura, New York (USA)


09/2003

  • Global Summit on Medicinal Plants (Mauritius)
  • Century Foundation and Bangalore University (India)


05/2000

  • 6th World Biomaterials Congress (Honolulu, Hawaii, USA)
  • Society for Biomaterials (USA)


05/2000

  • Jubilee Congress 50 Years German Society for Craniomaxillofacial Surgery (Berlin)
  • German Society for Craniomaxillofacial Surgery (Germany)


06/1997

  • 1st Medical Device Forum (Weimar)
  • Medical Device Academy Dr. Müller-Lierheim GmbH (Germany)


03/1997

  • Medical Device Conference (Köln)
  • PTS Pharma Training Service, Arnsberg (Germany)


05/1996

  • 5th World Biomaterials Congress (Toronto, Canada)
  • Society for Biomaterials (USA)


04/1995

  • Conformity Assessment of Medical Devices (Lübeck)
  • PTS Pharma Training Service, Arnsberg (Germany)


10/1988 ? 04/1994

  • Appointment as Member of the Civil Protection Office (Nürnberg)
  • City of Nürnberg, Office for Civil Protection (Germany)


11/1986

  • Training Course for Technical Consultants & Experts in Staff Function for Civil and Military Nuclear, Biological and Chemical Accidents
  • Civil Protection School of the German Government, Ahrweiler (Germany)


06/1986 ? 10/1988

  • Appointment as Member of the Radiation Protection Commission acc. the Tschernobyl Nuclear Reactor Accident
  • City of Nürnberg, Office for Civil Protection (Germany)


12/1983

  • Training Course for Heads of the Department for Civil and Military Nuclear, Biological and Chemical Accident Reporting and Evaluation
  • Civil Protection School of the German Government, Ahrweiler (Germany)


10/1980

  • Training Course for Staff of the Department for Civil and Military Nuclear, Biological and Chemical Accident Reporting and Evaluation ? Part 2
  • Bavarian School for Civil Protection, Geretsried (Germany)


02/1979

  • Training Course for Staff of the Department for Civil and Military Nuclear, Biological and Chemical Accident Reporting and Evaluation ? Part 1
  • Bavarian School for Civil Protection, Geretsried (Germany)

Kompetenzen

Kompetenzen

Top-Skills

Individuelle Lösungen nach Kundenbedarf

Produkte / Standards / Erfahrungen / Methoden

PROFESSIONAL EXPERIENCE:
2003 - heute

Rolle: Medical Device, IVD and Pharma Technology, R&D, RA/QA & GMP Consultant (Executive)

Kunde: ViARATiO CONSULTiNG, Freiberg a. N./Murr (Germany)


Aufgaben:

  • Consulting focus on medical device technology, IVD´s, biotechnology for tissue engineering and pharmaceutical technology (incl. clean room production, packaging and sterilization technology)
  • External project manager, trainer, expert and auditor for medical devices acc. MDD (Directive 93/42/EC), IVD-D (Directive 98/79/EG), MDR (EU), IVDR (EU), EN ISO 13485, EN ISO 9001, EN ISO 17025 & US QSR (cGMP) acc. 21 CFR 820; pharma projects acc. 21 CFR 210/211, EU GMP -, ICH -, PIC/S - & WHO Guidelines
  • Mock audits for FDA readiness (incl. GMP, GxP) and internal or unannounced audits (e.g. acc. 2013/473/EU)
  • Complaint management of all ?escalation? levels, root cause analysis, FMEA, CAPA & change control
    processes; DQ, IQ, OQ & PQ incl. validation (e.g. clean room processes, packaging, sterilization, transport etc.)
  • R&D, RA & QA consulting incl. of drug-device combination (?borderline?) products, DMF/DHF evaluations, MDR updating of technical documentations for regulatory approval purposes etc.
  • Consulting in the field of radiation protection for healthcare industries acc. StrlSchG & StrlSchV (D)


1997 ? 2002

Rolle: Chief Executive Officer (CEO)

Kunde: OSSACUR AG, Oberstenfeld/Tübingen (Germany)


Aufgaben:

  • Biotechnology based medical devices (class III) and drug-device combination products for surgical orthopedics, dentistry & CMF osteosynthesis
  • Surface-modified resorbable biomaterials for the human in-situ tissue engineering (incl. bioceramics, collagen, bone & cartilage morphogenic proteins)
  • Contract development of antibiotics containing drug-device combination products for Aventis Pharma


1995 ? 1997 
Rolle: Vice President R&D Biomaterials (VP)

Kunde: Pfizer / Howmedica Leibinger GmbH, Freiburg i. B. (Germany) / Dallas (USA)


Aufgaben:

  • Biomaterials (resorbable bioceramics, bone cements, biopolymers etc.) and implants (stainless steel, titanium alloys etc.) for osteosynthesis and CMF surgery
  • Surface coatings of titanium implants, packaging and sterilization technologies


1990 ? 1994 
Rolle: Scientific Assistant Biomaterials Research (FMZ Department for Functional Materials in Medicine and Dentistry)

Kunde: Julius-Maximilians-University, Würzburg (Germany)


Aufgaben:

  • Surface modification and PVD plasma coating technology for medical implants
  • Biomechanical, electrochemical and physical medical device testing
  • Interface reactions of biomaterials in the biological environment

1985 ? 1989

Rolle: Department Manager Galenics & Pharmaceutical Technology/Engineering

Kunde: Pfrimmer Kabi GmbH & Co. KG, Erlangen/Plattling (Germany)


Aufgaben:

  • Production technology development of oxygen sensitive drugs in liquid application (dosage) forms as well as shelf life testing (incl. prevention of Maillard reactions in multi-component formulations)
  • Research in the field of new perfluorcarbon based blood substitutes
  • Packaging, HTST & microwave sterilization technology of parenteral medicinal products


EXPERIENCES AS ACADEMIC LECTURER AND SUPERVISOR:
1990 - 1994

Kunde: Julius-Maximilians-University Würzburg (Germany)
Rolle: Academic Lecturer and Supervisor (FMZ Department of Materials in Medicine and Dentistry)


Aufgaben:

  • B. Priessnitz: Introduction in Online-Retrieval with Different Databases and Practical Exercises at the Hosts DIMDI, Köln and STN International, Karlsruhe (Participants: Doctoral Candidates of Natural Sciences, Medicine and Dentistry)
  • B. Priessnitz: Crash-Course Liquid-Scintillation Spectroscopy in Biochemistry (Participants: Doctoral Candidates of Dentistry)
  • R. Thull, B. Priessnitz, Ch. Michel, J. Bill: Radiological Course for Dentists with Special Consideration of Radiation Protection (Participants: Students of Dentistry with Preliminary Medical Examination)
  • B. Priessnitz: Introduction in Scientific Digital Imaging with OPTIMAS and Practical Exercises (Participants: Doctoral Candidates and Post Doctors of Medicine and Dentistry)
  • B. Priessnitz: HP-BASIC Programming Course of the IEEE-Bus with Selected Examples in the Art of Electronic Measurement (Participants: Candidates with the Master of Science Graduation and Doctoral Candidates in Dentistry and Orthopedics)
  • B. Priessnitz: Biomechanical Calculations and FEM-Analysis with ANSYS (Software) in Dentistry and Orthopedics (Participants: Doctoral Candidates of Medicine and Dentistry)
  • B. Priessnitz: Creation of Computer-Supported Methods for Mechanical and Biomechanical Materials Testing with a ZWICK Universal Materials Testing Device (Participants: Doctoral Candidates of Medicine and Dentistry)
  • R. Thull, A. Handrejk, B. Priessnitz: Exercises in Scanning Electron Microscopy (SEM) and Micro - probe Analysis (Energy Dispersive X-Ray Spectroscopy / EDX) (Participants: Doctoral Candidates of Dentistry)
  • R. Thull, B. Priessnitz, A. Handrejk: Instruction to Independent Scientific Research (Participants: Doctoral Candidates of Medicine and Dentistry)

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

6 Jahre 5 Monate
2019-07 - heute

Selection of periodic or ongoing projects

  • PPE technical innovations management (e. g. GRAMM medical healthcare GmbH)
  • Clean room, product and personnel monitoring for uncoated and cytostatic coated catheter production including GMP training (e. g. B. Braun Melsungen AG)
  • Consulting for the selection of personal protective equipment for the Wuhan Medical Center due to the Corona epidemic outbreak in Wuhan (China)
  • Technical processing of EU patent applications (Companies confidential)
  • CAPA management of external sterile disposables manufacturing (e. g. Brainlab AG)
  • Preparation and MDR updating of technical documentations for regulatory approval purposes incl. 510 (k) – applications (e. g. Deltacor GmbH)
  • Internal GMP- und QMS compliance audit acc. contract manufacturing of selected medical devices incl. hygiene training (e. g. WILD GmbH)
various companies
6 Monate
2019-01 - 2019-06

Spare Parts Management of Temporary Cardiopulmonary Support Systems

  • Spare parts manager of temporary cardio-pulmonary support system components incl. QC test methods verification
  • Gap analysis and investigations of hygiene management in the QC test lab incl. heater-cooler devices
LivaNova Deutschland GmbH
München
6 Monate
2018-07 - 2018-12

SME Quality Management acc. EN ISO 13485:2016

  • QMS update with risk-based approach according to the requirements of EN ISO 13485:2016; elimination of audit deviations and preparation of the re-certification audit
  • Restructuring of processes for design transfer as well as supplier qualification and assessment
JOTEC GmbH (CryoLife Inc.)
Hechingen
4 Monate
2018-03 - 2018-06

CAPA Management of Temporary Cardiopulmonary Support Systems

  • CAPA manager in the electronic operations and manufacturing department of temporary cardiopulmonary support system components
  • Root cause analysis and investigations of soldering processes and testing systems for circuit boards
LivaNova Deutschland GmbH
München
6 Monate
2017-09 - 2018-02

SME Sterile Eye & Wound Care Solutions

  • Project manager and SME for DMF remediations/revisions of sterile (single use) eye & wound care solutions including accessories and supplies (European and EMEA markets)
  • Cooperation with external contract manufacturing partners
  • Consulting and review of marketing materials including international competition analysis
First Aid Equipment Manufacturer
Germany
7 Monate
2017-01 - 2017-07

Peritoneal Dialysis Systems

International Engineering Project Manager
International Engineering Project Manager
  • Responsible project manager and team leader at Global Research & Development (GRD) for the next generation of the homecare peritoneal dialysis system including hard- and software, accessories and supplies (European and South American market)
  • Cooperation with external contract development and manufacturing partners
  • Complete documentation reviews for the technical file to fulfill all relevant regulatory requirements
Fresenius Medical Care
Bad Homburg & Schweinfurt
3 Monate
2016-07 - 2016-09

SME in International Complaint Management of Drug-Device Combination Products

  • International investigation and CAPA handling of inhaler systems for asthma therapy
  • Document & database (SAP, TrackWise etc.) management to fulfill the regulatory requirements acc. 21 CFR part 11 compliance etc.
Boehringer Ingelheim Pharma GmbH & Co. KG
Ingelheim
3 Monate
2016-02 - 2016-04

SME in GMP Readiness for Swiss Health Authority Inspections

  • Remediation of technology transfer processes (solid dosage form pharmaceuticals production relocation) acc. national and international GMP standards (incl. ICH Q7-Q10, PIC/S, EU-GMP & WHO Guidelines)
  • Remediation of cleaning validations and risk assessment related to cross contaminations acc. actual EMA requirements (PDE concept)
Acino Pharma AG
Aesch/BL
1 Jahr 3 Monate
2014-09 - 2015-11

International Customer Complaint Management

Team & Project Leader
Team & Project Leader
  • Investigations, CAPAs & technical risk assessments incl. interface to change control management for clinical (pre-analytical) laboratory automation systems according IVD Directive (Directive 98/79/EC), EN ISO 13485, EN ISO 14971 etc.
  • Handling of potential critical cases (PCCs) for the safety board of Roche Diagnostics
  • Document & database (SAP etc.) management to fulfill the regulatory requirements acc. 21 CFR part 11 compliance etc.
Roche PVT GmbH (Roche Diagnostics)
Waiblingen
6 Monate
2014-04 - 2014-09

Single & multiple use drug delivery systems

Head QA Medical Devices
Head QA Medical Devices
  • Single & multiple use drug delivery systems for injectable biopharmaceuticals (e.g. human growth hormones) and drug-device combination products
  • Management of device development reviews, risk assessments, packaging, sterilization and transport validations etc. according all international relevant standards and requirements incl. MDD (Directive 93/42/EC), EN ISO 13485, 21 CFR 820 etc.
  • Management of international device releases, deviations, complaints, CAPAs, internal & external audits incl. third parties (contract manufactures)
Sandoz GmbH (Novartis)
Kundl/Schaftenau
8 Monate
2013-08 - 2014-03

Risk assessment remediation of spine implants acc. EN ISO 14971

Senior CAPA & Risk Assessment SME Consultant
Senior CAPA & Risk Assessment SME Consultant
  • International complaint and CAPA management acc. FDA and EMEA standards, personnel training for root cause analysis techniques and risk assessment, packaging and sterilization validation
  • Continues process improvement for osteosynthesis implants and surgical instruments
  • Risk assessment remediation of spine implants acc. EN ISO 14971
DePuy Synthes (Johnson & Johnson)
Zuchwil/Oberdorf/Balsthal

Aus- und Weiterbildung

Aus- und Weiterbildung

1982 - 1989

Friedrich-Alexander-University Erlangen-Nürnberg (D)
Diplom-Physiker Univ. [Master of Science (M.Sc.) in Physics]


Aufgaben:

Basic Study in Chemistry / 1989 Thesis (Institute for Biomedical Engineering):
Investigation of the Electro reflectance and the Electrochemical Properties of n-Type Semiconducting
Oxide Electrodes on Titanium-Based Materials at the Oxide-Semiconductor/Electrolyte Interface


1975 - 1978

J. Pfrimmer + Co., Pharmaceutical Company, Erlangen (D)
Chemical Laboratory Assistant [Certificate of the Chamber of Industry and Commerce, IHK Nürnberg]


Aufgaben:

Vocational Training on Chemical Laboratory Assistant (Focus on analytical and pharmaceutical chemistry of amino acids, peptides, vitamins, carbohydrates, electrolytes etc., GMP of sterile enteral and parenteral solutions technology, Xylitol pilot plant production for astronaut food (NASA) etc., preparation of catgut and human dura mater implants with respect to the prevention of Creutzfeld Jakob disease (CJD) infections)

COURSES, CERTIFICATES, APPOINTMENTS:


03/2018

  • Certificate - Up-to-date Implementation Status of the EU Medical Device Regulation (EU MDR)
  • BVMed (MedInform) Conference, Köln (Germany)


03/2017

  • Actual Trends within the European Medical Device Regulation (EU MDR) ? MDR Implementation Recommendations ? Clinical Testing ? MDSAP
  • BVMed (MedInform) Conference, Bonn (Germany)


10/2011

  • V2011 ? Vacuum Coating and Plasma Surface Technology (Dresden)
  • EFDS ? European Society of Thin Films e. V., Dresden (Germany)


01/2011

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2011
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2010

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2010
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2009

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2009
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2008

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2008
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


11/2007

  • The Osteoblast (Würzburg)
  • Orthopedic University Clinic Würzburg, Prof. Dr. med. J. Eulert (Germany)


09/2007

  • Liability Issues for Manufacturers and Distributors of Medical Devices
  • EUROSPEC ? Institute of Equipment Safety and Quality Management, Darmstadt (Germany)


08/2007 ? 07/2010

  • Extension appointment as external medical device auditor/expert regarding EN ISO 13485 & MDD (Directive 93/42/EC)
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


01/2007

  • Certificate ? Annual external medical device auditors/experts experience exchange meeting 2007
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


11/2005

  • Tibetan Medicine for Chronic Diseases (Zürich, Switzerland)
  • University Hospital Zürich, Institute for Natural Medicine (CH), Licence: 1-222-1-05-P50


07/2004 ? 07/2007

  • Appointment as external medical device auditor/expert regarding EN ISO 13485 & MDD (Directive 93/42/EC)
  • LGA Intercert GmbH, Nürnberg (Notified Body No. 1275, Germany)


11/2003

  • 2nd International Congress on Tibetan Medicine (Washington DC, USA)
  • Pro-Cultura, New York (USA)


09/2003

  • Global Summit on Medicinal Plants (Mauritius)
  • Century Foundation and Bangalore University (India)


05/2000

  • 6th World Biomaterials Congress (Honolulu, Hawaii, USA)
  • Society for Biomaterials (USA)


05/2000

  • Jubilee Congress 50 Years German Society for Craniomaxillofacial Surgery (Berlin)
  • German Society for Craniomaxillofacial Surgery (Germany)


06/1997

  • 1st Medical Device Forum (Weimar)
  • Medical Device Academy Dr. Müller-Lierheim GmbH (Germany)


03/1997

  • Medical Device Conference (Köln)
  • PTS Pharma Training Service, Arnsberg (Germany)


05/1996

  • 5th World Biomaterials Congress (Toronto, Canada)
  • Society for Biomaterials (USA)


04/1995

  • Conformity Assessment of Medical Devices (Lübeck)
  • PTS Pharma Training Service, Arnsberg (Germany)


10/1988 ? 04/1994

  • Appointment as Member of the Civil Protection Office (Nürnberg)
  • City of Nürnberg, Office for Civil Protection (Germany)


11/1986

  • Training Course for Technical Consultants & Experts in Staff Function for Civil and Military Nuclear, Biological and Chemical Accidents
  • Civil Protection School of the German Government, Ahrweiler (Germany)


06/1986 ? 10/1988

  • Appointment as Member of the Radiation Protection Commission acc. the Tschernobyl Nuclear Reactor Accident
  • City of Nürnberg, Office for Civil Protection (Germany)


12/1983

  • Training Course for Heads of the Department for Civil and Military Nuclear, Biological and Chemical Accident Reporting and Evaluation
  • Civil Protection School of the German Government, Ahrweiler (Germany)


10/1980

  • Training Course for Staff of the Department for Civil and Military Nuclear, Biological and Chemical Accident Reporting and Evaluation ? Part 2
  • Bavarian School for Civil Protection, Geretsried (Germany)


02/1979

  • Training Course for Staff of the Department for Civil and Military Nuclear, Biological and Chemical Accident Reporting and Evaluation ? Part 1
  • Bavarian School for Civil Protection, Geretsried (Germany)

Kompetenzen

Kompetenzen

Top-Skills

Individuelle Lösungen nach Kundenbedarf

Produkte / Standards / Erfahrungen / Methoden

PROFESSIONAL EXPERIENCE:
2003 - heute

Rolle: Medical Device, IVD and Pharma Technology, R&D, RA/QA & GMP Consultant (Executive)

Kunde: ViARATiO CONSULTiNG, Freiberg a. N./Murr (Germany)


Aufgaben:

  • Consulting focus on medical device technology, IVD´s, biotechnology for tissue engineering and pharmaceutical technology (incl. clean room production, packaging and sterilization technology)
  • External project manager, trainer, expert and auditor for medical devices acc. MDD (Directive 93/42/EC), IVD-D (Directive 98/79/EG), MDR (EU), IVDR (EU), EN ISO 13485, EN ISO 9001, EN ISO 17025 & US QSR (cGMP) acc. 21 CFR 820; pharma projects acc. 21 CFR 210/211, EU GMP -, ICH -, PIC/S - & WHO Guidelines
  • Mock audits for FDA readiness (incl. GMP, GxP) and internal or unannounced audits (e.g. acc. 2013/473/EU)
  • Complaint management of all ?escalation? levels, root cause analysis, FMEA, CAPA & change control
    processes; DQ, IQ, OQ & PQ incl. validation (e.g. clean room processes, packaging, sterilization, transport etc.)
  • R&D, RA & QA consulting incl. of drug-device combination (?borderline?) products, DMF/DHF evaluations, MDR updating of technical documentations for regulatory approval purposes etc.
  • Consulting in the field of radiation protection for healthcare industries acc. StrlSchG & StrlSchV (D)


1997 ? 2002

Rolle: Chief Executive Officer (CEO)

Kunde: OSSACUR AG, Oberstenfeld/Tübingen (Germany)


Aufgaben:

  • Biotechnology based medical devices (class III) and drug-device combination products for surgical orthopedics, dentistry & CMF osteosynthesis
  • Surface-modified resorbable biomaterials for the human in-situ tissue engineering (incl. bioceramics, collagen, bone & cartilage morphogenic proteins)
  • Contract development of antibiotics containing drug-device combination products for Aventis Pharma


1995 ? 1997 
Rolle: Vice President R&D Biomaterials (VP)

Kunde: Pfizer / Howmedica Leibinger GmbH, Freiburg i. B. (Germany) / Dallas (USA)


Aufgaben:

  • Biomaterials (resorbable bioceramics, bone cements, biopolymers etc.) and implants (stainless steel, titanium alloys etc.) for osteosynthesis and CMF surgery
  • Surface coatings of titanium implants, packaging and sterilization technologies


1990 ? 1994 
Rolle: Scientific Assistant Biomaterials Research (FMZ Department for Functional Materials in Medicine and Dentistry)

Kunde: Julius-Maximilians-University, Würzburg (Germany)


Aufgaben:

  • Surface modification and PVD plasma coating technology for medical implants
  • Biomechanical, electrochemical and physical medical device testing
  • Interface reactions of biomaterials in the biological environment

1985 ? 1989

Rolle: Department Manager Galenics & Pharmaceutical Technology/Engineering

Kunde: Pfrimmer Kabi GmbH & Co. KG, Erlangen/Plattling (Germany)


Aufgaben:

  • Production technology development of oxygen sensitive drugs in liquid application (dosage) forms as well as shelf life testing (incl. prevention of Maillard reactions in multi-component formulations)
  • Research in the field of new perfluorcarbon based blood substitutes
  • Packaging, HTST & microwave sterilization technology of parenteral medicinal products


EXPERIENCES AS ACADEMIC LECTURER AND SUPERVISOR:
1990 - 1994

Kunde: Julius-Maximilians-University Würzburg (Germany)
Rolle: Academic Lecturer and Supervisor (FMZ Department of Materials in Medicine and Dentistry)


Aufgaben:

  • B. Priessnitz: Introduction in Online-Retrieval with Different Databases and Practical Exercises at the Hosts DIMDI, Köln and STN International, Karlsruhe (Participants: Doctoral Candidates of Natural Sciences, Medicine and Dentistry)
  • B. Priessnitz: Crash-Course Liquid-Scintillation Spectroscopy in Biochemistry (Participants: Doctoral Candidates of Dentistry)
  • R. Thull, B. Priessnitz, Ch. Michel, J. Bill: Radiological Course for Dentists with Special Consideration of Radiation Protection (Participants: Students of Dentistry with Preliminary Medical Examination)
  • B. Priessnitz: Introduction in Scientific Digital Imaging with OPTIMAS and Practical Exercises (Participants: Doctoral Candidates and Post Doctors of Medicine and Dentistry)
  • B. Priessnitz: HP-BASIC Programming Course of the IEEE-Bus with Selected Examples in the Art of Electronic Measurement (Participants: Candidates with the Master of Science Graduation and Doctoral Candidates in Dentistry and Orthopedics)
  • B. Priessnitz: Biomechanical Calculations and FEM-Analysis with ANSYS (Software) in Dentistry and Orthopedics (Participants: Doctoral Candidates of Medicine and Dentistry)
  • B. Priessnitz: Creation of Computer-Supported Methods for Mechanical and Biomechanical Materials Testing with a ZWICK Universal Materials Testing Device (Participants: Doctoral Candidates of Medicine and Dentistry)
  • R. Thull, A. Handrejk, B. Priessnitz: Exercises in Scanning Electron Microscopy (SEM) and Micro - probe Analysis (Energy Dispersive X-Ray Spectroscopy / EDX) (Participants: Doctoral Candidates of Dentistry)
  • R. Thull, B. Priessnitz, A. Handrejk: Instruction to Independent Scientific Research (Participants: Doctoral Candidates of Medicine and Dentistry)

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