Lectures

Insights on Combination Products, Devices, and More

Lectures

Insights on Combination Products, Devices, and More

Lectures

Insights on Combination Products, Devices, and More

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.

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.

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.

I frequently serve as a speaker at conferences, seminars, and other events, delivering insightful lectures on a wide range of topics.

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:

Some of the subjects I cover include:

Some of the subjects I cover include:

Medical Devices and (Drug/Device) Combination Products

Medical Devices and (Drug/Device) Combination Products

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)

  • 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)

  • 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

Pharmaceutical Packaging

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

Specific Products and Technologies

Specific Products and Technologies

  • Pre-filled Syringes (PFS)

  • Medical Software / Medical Apps

  • Utilization of Radio Frequency Identification (RFID) in the Healthcare Environment

  • Pre-filled Syringes (PFS)

  • Medical Software / Medical Apps

  • Utilization of Radio Frequency Identification (RFID) in the Healthcare Environment

  • 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.

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

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

Upcoming presentations

Pharmazeutische Packmittel aus Kunststoff und Elastomeren

10./11. Oktober 2024

Mannheim

Concept Heidelberg

Presentations

Lieferantenqualifizierung

Regulatorische Anforderungen an Medizinprodukte

Prüfung von Packmitteln aus Kunststoffen in der Wareneingangskontrolle

Pharmazeutische Packmittel aus Kunststoff und Elastomeren

10./11. Oktober 2024

Mannheim

Concept Heidelberg

Presentations

Lieferantenqualifizierung

Regulatorische Anforderungen an Medizinprodukte

Prüfung von Packmitteln aus Kunststoffen in der Wareneingangskontrolle

Pharmazeutische Packmittel aus Kunststoff und Elastomeren

10./11. Oktober 2024

Mannheim

Concept Heidelberg

Presentations

Lieferantenqualifizierung

Regulatorische Anforderungen an Medizinprodukte

Prüfung von Packmitteln aus Kunststoffen in der Wareneingangskontrolle

Pharmazeutische Packmittel aus Kunststoff und Elastomeren

10./11. Oktober 2024

Mannheim

Concept Heidelberg

Presentations

Lieferantenqualifizierung

Regulatorische Anforderungen an Medizinprodukte

Prüfung von Packmitteln aus Kunststoffen in der Wareneingangskontrolle

Design Controls for Drug-Device Combination Products

15./16. Oktober 2024

Live Online Training

ECA

Presentations

Design Controls – An Introduction

EU Requirements for Drug-Device Combinations

Design Input, Design Output

Design Transfer

Design Changes

Design Controls for Drug-Device Combination Products

15./16. Oktober 2024

Live Online Training

ECA

Presentations

Design Controls – An Introduction

EU Requirements for Drug-Device Combinations

Design Input, Design Output

Design Transfer

Design Changes

Design Controls for Drug-Device Combination Products

15./16. Oktober 2024

Live Online Training

ECA

Presentations

Design Controls – An Introduction

EU Requirements for Drug-Device Combinations

Design Input, Design Output

Design Transfer

Design Changes

Design Controls for Drug-Device Combination Products

15./16. Oktober 2024

Live Online Training

ECA

Presentations

Design Controls – An Introduction

EU Requirements for Drug-Device Combinations

Design Input, Design Output

Design Transfer

Design Changes

Pharmaceutical Packaging Systems: Part 1 - Development

26./27. November 2024

Live Online Training

ECA

Presentations

Development of Drug/Device Combination Products

Pharmaceutical Packaging Systems: Part 1 - Development

26./27. November 2024

Live Online Training

ECA

Presentations

Development of Drug/Device Combination Products

Pharmaceutical Packaging Systems: Part 1 - Development

26./27. November 2024

Live Online Training

ECA

Presentations

Development of Drug/Device Combination Products

Pharmaceutical Packaging Systems: Part 1 - Development

26./27. November 2024

Live Online Training

ECA

Presentations

Development of Drug/Device Combination Products

Pharmaceutical Packaging Systems: Part 2 - Quality Control

27./28. November 2024

Live Online Training

ECA

Presentations

Defect Evaluation Lists

Technical Specifications

Shelf-life of Packaging Components

Pharmaceutical Packaging Systems: Part 2 - Quality Control

27./28. November 2024

Live Online Training

ECA

Presentations

Defect Evaluation Lists

Technical Specifications

Shelf-life of Packaging Components

Pharmaceutical Packaging Systems: Part 2 - Quality Control

27./28. November 2024

Live Online Training

ECA

Presentations

Defect Evaluation Lists

Technical Specifications

Shelf-life of Packaging Components

Pharmaceutical Packaging Systems: Part 2 - Quality Control

27./28. November 2024

Live Online Training

ECA

Presentations

Defect Evaluation Lists

Technical Specifications

Shelf-life of Packaging Components

Pre-filled syringes and injectable drug devices Europe

14.-16. January 2025

London, UK

SAE Media Group

Presentations

Impact of Medical Device Regulation on Drug-Device Combinations: A Current Overview

Pre-filled syringes and injectable drug devices Europe

14.-16. January 2025

London, UK

SAE Media Group

Presentations

Impact of Medical Device Regulation on Drug-Device Combinations: A Current Overview

Pre-filled syringes and injectable drug devices Europe

14.-16. January 2025

London, UK

SAE Media Group

Presentations

Impact of Medical Device Regulation on Drug-Device Combinations: A Current Overview

Pre-filled syringes and injectable drug devices Europe

14.-16. January 2025

London, UK

SAE Media Group

Presentations

Impact of Medical Device Regulation on Drug-Device Combinations: A Current Overview

Torsten Kneuss is an engineer near Berlin with 25+ years in the pharmaceutical industry, specializing in packaging, medical devices, and combination products. 

© Copyright 2023-2024, All Rights Reserved by Torsten Kneuss

Torsten Kneuss is an engineer near Berlin with 25+ years in the pharmaceutical industry, specializing in packaging, medical devices, and combination products. 

© Copyright 2023-2024, All Rights Reserved by Torsten Kneuss

Torsten Kneuss is an engineer near Berlin with 25+ years in the pharmaceutical industry, specializing in packaging, medical devices, and combination products. 

© Copyright 2023-2024, All Rights Reserved by Torsten Kneuss

Torsten Kneuss is an engineer near Berlin with 25+ years in the pharmaceutical industry, specializing in packaging, medical devices, and combination products. 

© Copyright 2023-2024, All Rights Reserved by Torsten Kneuss