With expertise gathered from more than 25 years in responsible positions in the healthcare sector, Dr Stefan Kettelhoit offers practical consulting on an equal footing..

Experience

Dr Stefan Kettelhoit holds a doctorate in pharmacy and has worked in management at international pharmaceutical companies, start-ups and SMEs – with responsibility for product development, process auditing and corporate development.

As a freelancer and qualified person according to §15 AMG, he audits quality management systems and assumes responsibility for the release of medicinal products on behalf of customers. A special field is the pharmaceutical requirements for cannabis ingredients (THC, CBD) and cannabis flowers.

In addition, Dr Kettelhoit advises manufacturers of non-active medical devices with special regard to "intelligent care and digitalisation". His range of services includes consulting and auditing on MDD/MDR requirements of the conformity assessment procedure as well as project management for the corresponding processes.

His market knowledge in the fields of pharmaceuticals, medical technology, analytics and nursing care allows him to offer competent, sustainable consulting based on his practical experience.

 

Publications

  • Industrielle Herstellung von Glasspritzen / Von der Glasröhre zur anwendungsfertigen Spritze, PharmInd, 70, Nr. 10 2008, p 1261-1269
  • API Manufacturing: Complying with International GMP Regulations, Pharma Asia June 1st, 2009
  • GMP for Active Pharmaceutical Ingredients: Judging the Audit Quality from the Audit Report, PharmInd, 72, Nr. 2 (2010)
  • Compliance of APIs with International GMP Regulations, Pharma, Sep. 2011, 8-10 (2011)
  • Risk-Based Auditing of Active Pharmaceutical Ingredient Manufacturers – Recommendations for standards and minimal requirements, PharmInd, 74, Nr. 6 (2012)
  • Achieving More Effective and Efficient GMP Auditing, Pharmaceutical Technology, Feb. 2013
  • GMP-Zertifikate, Pharmind 12/2013, 1978-1979 & GMP-Berater / LOGFILE Nr. 26/2013
  • Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen, GMP-Berater / LOGFILE Nr. 41/2013
  • Audits & Inspections - Do’s and Don’t’s, China Medi Trade, May 2014, pp. 22-26
  • Audits bei Lohnherstellern, Pharm. Ind. 76, Nr. 4, 544–550 (2014)
  • folgende Kapitel im GMP-BERATER:
    20.C Zulassungsdokumentation von Wirkstoffen: EDMF/ASMF und CEP

Competences

QM consulting

  • Consultation regarding the implementation of quality management systems
  • Assumption of responsibility as Qualified Person according to § 15 AMG
  • Creation of SOPs
  • Risk assessment
  • Etc.

Professional experience

  • Canopy Growth
    Interim-Management / Qualified Person according to §15 AMG
  • Hermann Bock GmbH (nursing care beds and intelligent care)
    Shareholder, General Manager
  • Johann-Wilhelm-Ritter-Klinik (specialist clinic for dermatology)
    General Manager
  • blue inspection body GmbH (inspection body for GMP Audits)
    Founder, shareholder, General Manager
  • Sepaserve GmbH (analytics and bioscience)
    Founder and shareholder
  • Implanta AG (medical technology)
    Head of Development and Production
  • Bayer AG (pharmaceuticals)
    International Project Manager

Patents

  • EP-761210 – Controlled release pharmaceutical prodn. esp. for dihydro-pyridine – by mixing drug, cellulose ether, polyvinyl lactam (co)polymer etc. without solvent, shaping and heating
  • WO-9921535 – Single-chamber osmotic pharmaceutical release system
  • WO-9915172 – Controlled release moxifloxacin antibacterial formulations
  • DE-10344537 –  Stent implantation catheter for stents that can be hardened by irradiation
  • D-Anmeldung – Stent implantation catheter (2)Stentimplantationskatheter (2)
  • EP-3067033A1 – Bed, particularly hospital and/or nursing care bed, with DECT interface
  • EP-3287111A1 – Bed, particularly hospital and/or nursing care bed