Seminar leader
Andreas Thurnheer,
BSc in Chemistry – Niutec AG
Arne Jaksch,
Dr. in Chemistry – JLSC GmbH
The Seminar will be in German.
Location and costs
Park Hotel Winterthur
Stadthausstrasse 4, 8400 Winterthur
CHF 890.- exkl. MwSt. / Attendees
Incl. coffee, drinks, refreshments during breaks,
Lunch, documents and certificate
Next appointment
Are you interested? Please do not hesitate to contact us.
Cleanliness according to EN ISO 19227 is a key issue in the production of medical devices.
EN ISO 19227 clearly establishes the general requirements for product cleanliness.
But how do you put EN ISO 19227 requirements into practice? And how do you adapt internal manufacturing and cleaning processes to these requirements?
In our seminars, we examine individual aspects, risks and methods, helping you to implement the requirements professionally and correctly.
TARGET GROUP
The seminar is aimed at employees in the areas of quality, regulatory affairs, compliance and production who deal with the planning, evaluation, supervision and documentation relating to the validation and monitoring of the cleaning process.
CONTENTS
- Requirements for the cleanliness of medical devices according to ISO 19227
- Identification of risks and creation of a cleanliness regime
- Worst case products
- Pollution categories
- Classification of processing aids into pollution categories
- Analytical methods for cleanliness according to ISO 19227
- Interpretation of the results and decision on appropriate measures
- Collective review of concrete practical examples
WHAT YOU GAIN
- Improvement in quality through simple concepts
- Differentiation of pollution categories
- Targeted use of cleanliness tests
- Quick decision-making tools based on simple parameters
- Identification of the risks associated with the cleanliness of the end product and establishment of appropriate control and monitoring measures
- Guaranteed correct implementation of regulatory requirements