Robert G. Schwarz
GXP-TrainCon
Referent:innen
Marc Seegers
mdc
Specialities of cleaning validation in the field of medical devices (classes 2a, 2b, and 3)
Zielgruppe
This is for staff in quality management, regulatory affairs, development, production, and validation who are into cleaning validation for medical devices (including in vitro diagnostics). Combination products pose an additional challenge here in that they are either classified as medicinal products or as medical devices based on their primary functionality, and the topic cleaning validation must then be addressed accordingly.
Zielsetzung
The requirements regarding cleanliness level of medical devices in the context of manufacturing are less specific than those for pharmaceuticals due to the heterogeneity of this product group. This also has an impact on cleaning validation and the definition of acceptance criteria. Standards for various product types attempt to address this issue.
In principle, the basic approach of cleaning validation for medical devices is comparable to that for pharmaceuticals: developing the cleaning process, establishing analytical methods for identifying contamination from the manufacturing process, risk analysis to determine sampling locations and methods. Determination and justification of acceptance criteria. However, there is a significant difference in the determination of limit values. Acceptance criteria based on toxicological data (PDE) do not exist in the medical device sector based on product characteristics.
Formal steps like the creation of the validation protocol, its implementation, the evaluation of the samples, and the validation report are then comparable to those for medicinal products. However, there are no clear specifications in the medical device sector, e.g. who is responsible for cleaning validation, apart from the ultimate responsibility lying with the manufacturer.
The goal of this event is to give you an overview of the regulatory requirements from the perspective of a representative of a notified body. You will also learn about the parallels and differences between the cleaning validation of medical devices and pharmaceuticals. And you will receive specific tips on implementation, including how to determine possible acceptance criteria.
Programm
Fundamental Regulatory and Normative Requirements regarding theCcleaning of Medical Devices
- ISO 13485
- 21 CFR 820
- ASTM F3127
- ISO 8250 as a continuation of DIN TS 5343
- ISO 19227
Differences from Pharmaceuticals and practical approaches for Implementing Cleaning Validation in the Field of Medical Devices
- Differences from the regulations governing pharmaceutical manufacturing (Annex 15, FDA Guide to Inspection of Cleaning Validation, and other industry recommendations).
- Rationale for cleaning validation of medical devices
- Risk analyses in the context of cleaning validation of medical devices
- The crucial question: What are the acceptance criteria?
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 690,-
ECA Members EUR 590,-
EU GMP Inspectorates EUR 490,-
Non-ECA Members EUR 690,-
ECA Members EUR 590,-
EU GMP Inspectorates EUR 490,-
The conference fee is payable in Advance after receipt of invoice.
VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Sven Pommeranz, +49 (0) 62 21 84 44 47, pommeranz@concept-heidelberg.de.
Questions regarding organisation:
Ms Julia Grimmer, +49 (0) 6221 84 44 44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 14 April 2026, 13.30 - 16.30 h
All times mentoined are CEST.
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 490,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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