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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 |
|---|---|---|
| 2023 | ||
| 23. November | Fundamentals of AQL Testing in Packaging Control | Full Seminar |
| 28./29. November | Qualitätsprüfung pharmazeutischer Packmittel (PM 1) |
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| 29./30. November | Entwicklung pharmazeutischer Packmittel (PM 2) |
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Past presentations
| Date | Seminar/Conference | My presentations |
|---|---|---|
| 2023 | ||
| 22./23. Mai | Jahrestagung "Pharma Packaging" |
|
| 2022 | ||
| 30. November + 01. December | Pharmaceutical Packaging Systems - Part 2 - Quality Control - Live Online Training |
|
| 29./30. November | ECA course Pharmaceutical Packaging Systems: Development |
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| 05./06. October | Design Controls for Drug - Device Combination Products |
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| 27./28. September | Pharmazeutische Packmittel aus Kunststoff (und Elastomeren) |
|
| 11. May | MEGRA Startup Medizinprodukte - Modul 06: "Risk Management und Vigilanz" |
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| 2.-4. February | Module 3: Regulatory Requirements for a New Active Substance: Quality |
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| 1. February | MEGRA Startup Medizinprodukte - Modul 2 "Technisches Dossier" |
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