Webinar

START 5 Webinar

The live webinar focuses on the latest aspects of biocompatibility and ethylene oxide sterilization (EO/EtO) requirements. It is suitable for people responsible for the quality, regulatory, R&D, vigilance, clinical evaluation, and management of medical device manufacturers.

The live webinar is for all, who want to find state-of-the-art approaches and requirements, and most important: how to handle them!

The biocompatibility part which takes 2h, will answer the following questions:

What are the requirements of MDR, ISO 10993, Notified Bodies and Competent Authorities?
Biological Evaluation Plan (BEP), Biological Evaluation Report/Biological Risk Assessment (BER/BRA) – how to waive some testing using it?
How to prepare samples for testing? How many samples are needed? How do I need to be prepared?
What is the role of ISO 17025 and GLP?
Which tests are needed for my medical device?
ISO 10993-18 chemical characterization (extractables & leachables) – how to handle that?
How to plan extraction strategy and solvent selection?
What is the role of Analytical Evaluation Threshold (AET) calculation and analytical uncertainty factor?
Toxicological evaluation ISO 10993-17 – is it always necessary?
How long does biocompatibility testing take?
Which changes in medical devices require additional testing?
A new standard revision – do I need to test my product again?
What are the biocompatibility testing requirements in various countries?

The EO sterilization part which takes 1h, will answer the following questions:

What basic knowledge of microbiology is necessary for you?
What are the advantages and disadvantages of EO sterilization?
What is the flow of a typical EO sterilization process?
What is the influence of critical parameters on the effectiveness of EO sterilization process
How to validate EO sterilization process?
How to calculate D-value?
How to create appropriate PCDs?
How to determine half-cycle dwell time?
How to determine residuals level?
What challenges can you expect during EO process validation?

Webinar price is 100 € (the price does not include VAT tax)

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Dr. Łukasz Szymański

Ph.D. in medical sciences
35 publications in scientific journals with an impact factor
Principal investigator or co-investigator in >10 scientific projects
Head, principal investigator, or co-investigator in >10 R&D projects
Evidence-based Toxicology, Johns Hopkins University
Polish Society of Toxicology member
Principle GLP Investigator
OECD Expert Group member in immunotoxicology
Certified Internal Auditor ISO 19011
Notified Body Technical Expert

Dr. Damian Matak

Ph.D. in medical sciences, M.Sc. and Eng. in biotechnology, postgraduate degrees in management, clinical trials, evidence-based toxicology
Member of Polish Society of Toxicology, I Local Ethical Committee
Expert of OECD Group in immunotoxicology, Foundation for Polish Science, National Centre for Research and Development, Medical Research Agency
Author or co-author of >15 scientific articles and book chapters
Recipient of >10 scientific awards
Inventor of III-class medical devices, experienced in the certification process
CEO of ISO 17025-accredited, and GLP-certified laboratories specialized in comprehensive medical device testing: chemistry, biocompatibility, microbiology & sterility, reprocessing validation, packaging validation, and aging

Dr. Andrzej Decewicz

Medical degree, Specialty – gynecology, obstetrics, cytology, ultrasonography
10+ Years of medical practice
30+ Years of medical industry practice including sterilization and validation
Experienced in clinical evaluation and risk management
Experienced in the validation of EO sterilization process
Experienced in the design and development of medical devices
Inventor of 14 patented medical devices or improvements
CEO of medical devices manufacturer

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