Speakers: Monica Grekula & Lina Burman, Biocompatibility Experts
Date: February 20th & 22nd 2024, Online
Duration: 6 hours | 2x 8:00 – 11:00 AM (EST), 2:00 – 5:00 PM (CET)
About the Speakers:
Monica Grekula – ERT (European Registered Toxicologist), MSc Applied Toxicology, MSc Pharma
Monica has over 25 years of experience in the field of medical devices, mainly within biological evaluation, in all phases of class I – class III medical devices, as well as combination products. With experience in full life-cycle risk management, setting up procedures and leading teams, Monica has been involved in different development projects, both within pharma and medical devices. Active within standardization, ISO 10993 and ISO 18562 series.
Lina Burman – PhD in Polymer Technology with a focus on the evaluation of migration and degradation behavior of polymeric materials
Lina has over 15 years of experience in the medical device industry working mainly with biological evaluations and toxicological assessments, of which 10 years as part of the development team of breathing gas pathway-related devices. She has been responsible for the evaluation of class I – class III devices for the EU and US markets. In addition, Lina is experienced in clinical evaluations, environment-related requirements, failure evaluations, chemical characterization, and QMS. She is also active in standardization, ISO 10993 and ISO 18562 series.
Training Objectives:
By attending this training, you will develop a basic understanding of biocompatibility-related issues and requirements and you can reduce the risk of:
Time-consuming and costly mistakes when choosing materials;
Having to re-do testing;
Biocompatibility-related adverse events following material changes;
Deviations related to material changes at audits; and
Questions at filing to notified body and authorities.
The course will improve your understanding of biocompatibility to:
Ensure timely consideration of biocompatibility-related aspects during development;
Facilitate discussions with those responsible for biological evaluation and test houses; and
Ease reviewing of biocompatibility-related documentation for regulatory purposes or clinical evaluations.
The course also provides a good introduction to the area if you will be working with biological evaluations and you are new to the field.
Training Content:
Day 1:
- Definition and connection to other processes – risk management, clinical evaluation, quality system process (ISO 14971, ISO 14155, ISO 13485) and Design Development
- ISO 10993-1 general principles and process
- Endpoints of concern and product-specific hazards
- Information needed for biological evaluation, incl. choice of chemical information or chemical analysis
- Overview ISO 10993 remaining standards
- Changes that trigger the update of evaluation and case studies
- Group exercise
Day 2:
- Basics to think about in material selection and dealing with suppliers
- Basics to think of when setting up tests with test house
- Biological testing
- Chemical characterization
- Key points to be covered due to the EU MDR 2017/745 GSPR
- What notified bodies want to see
- Global aspects
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment
- Participants will receive a training certificate stating the inclusion of measurement of the effectiveness of the training
Who Should Attend:
This course is for beginners and covers basic needs – Suitable for those who need a basic understanding, e.g. working as project managers, R&D engineers, regulatory managers, quality engineers, sustaining engineers, and/or involved in vigilance investigations and clinical evaluations, as well as beginners within biological evaluations.
Price:
EUR 620 including course material and certificate.