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)
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