Lectures - Insights on Combination Products, Devices, and More

Lectures by Torsten Kneuss
Photo by Nathan Dumlao / Unsplash
If you are seeking a speaker for your conference, seminar, or any other event within my areas of expertise, I would be delighted to participate. Please feel free to reach out to me, and I will gladly discuss how I can contribute to making your event a success by providing valuable insights to your participants.

I frequently serve as a speaker at conferences, seminars, and other events, delivering insightful lectures on a wide range of topics. Some of the subjects I cover include:

  • Medical Devices and (Drug/Device) Combination Products
    • Development and Design Control (in compliance with ISO 13485/21 CFR Part 820.30)
    • Quality Management (in accordance with ISO 13485/21 CFR Part 820), including Post-Market Surveillance and Vigilance requirements
    • Risk Management (following ISO 14971)
  • Pharmaceutical Packaging
    • Regulatory Compliance Requirements
    • Development Processes
    • Quality Control (e.g., Specifications, Defect Evaluation Lists, AQL, Test Methods, Planning and Conducting Incoming Goods Inspection)
  • Specific Products and Technologies
    • Pre-filled Syringes (PFS)
    • Medical Software / Medical Apps
    • Utilization of Radio Frequency Identification (RFID) in the Healthcare Environment

My presentations are available in either the German or English language.

Upcoming presentations

Date Seminar/Conference My presentations
01. February Glass Packaging Systems - Current & Upcoming Requirements, Challenges and Solutions
  • Requirements for Glass Containers used in Combination Products

Past presentations

Date Seminar/Conference My presentations
29./30. November Entwicklung pharmazeutischer Packmittel (PM 2)
  • Entwicklung von Combination Products
  • Festlegung von Spezifikationen und Auswahl von Prüfmethoden
28./29. November Qualitätsprüfung pharmazeutischer Packmittel (PM 1)
  • Lieferantenqualifizierung – Praxisorientierte Vorgehensweise zur Anerkennung von Packmittel-Lieferanten
  • Festlegung von Prüfungsumfängen auf Basis von Risikoanalysen
23. November Fundamentals of AQL Testing in Packaging Control Full Seminar
22./23. May Jahrestagung "Pharma Packaging"
  • Herausforderungen bei Verpackungen von Kombinationsprodukten
30. November + 01. December Pharmaceutical Packaging Systems - Part 2 - Quality Control - Live Online Training
  • Defect Evaluation Lists
  • Technical Specifications
  • Shelf-life of Packaging Components
29./30. November ECA course Pharmaceutical Packaging Systems: Development
  • Development of Drug/Device Combination Products
05./06. October Design Controls for Drug - Device Combination Products
  • Design Controls – An Introduction
  • Design and development planning / Scope of DC
  • EU Requirements for Single-Integral products
  • Design Input
  • Design Transfer
27./28. September Pharmazeutische Packmittel aus Kunststoff (und Elastomeren)
  • Regulatorische Anforderungen an Medizinprodukte
  • Lieferantenqualifizierung
  • Prüfung von Packmitteln aus Kunststoffen in der Wareneingangskontrolle
11. May MEGRA Startup Medizinprodukte - Modul 06: "Risk Management und Vigilanz"
  • ISO 14971 und ISO/TR 24971 - Einführung
2.-4. February Module 3: Regulatory Requirements for a New Active Substance: Quality
  • Pharmaceutical Packaging
1. February MEGRA Startup Medizinprodukte - Modul 2 "Technisches Dossier"
  • Technisches Dossier
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