Haribabu S., Toxicologist & Subject Matter Expert and Kushalappa.M.D, Project Engineer will be conducting a free seminar on Biological Safety Evaluation and Packaging Testing for Medical Devices on April 18, 2018.
- Understand the principles governing the biological evaluation of medical devices based on risk management process.
- Implement the strategy and stepwise approach to identify the biological end points Biological risk/safety assessment based on toxicological end points
- Recent changes in the standards to fulfill regulatory requirements.
- Medical devices categorization based on Nature of contact Duration of contact Biocompatibility test methods based on ISO 10993 standards
- ISO 10993-Part 3
- ISO 10993-Part 4
- ISO 10093-Part 5
- ISO 10993-Part 6
- ISO 10993-Part 10
- ISO 10993-Part 11
- Packaging Testing for Medical Devices(ISTA 2 A and ISO 11607 Requirement)
Introduction to Biological Evaluation of Medical Devices
- Introduction of ISO 10993
- Biological Evaluation Steps
- Role of Material Characterization
- Toxicology risk assessment
- Basic three biocompatibility tests
- Sub-acute, chronic toxicity, Implantation
- FDA recommended end points
- Role of Sample preparation and extraction
Packaging Testing for Medical Devices(ISTA 2 A and ISO 11607 Requirement)
- Key terms and definitions
- Simulation of life cycle of a medical device
- Typical life cycle
- Regulations and Standards
- Packaging validation test -ISTA 2 A (International Safe Transit Association)
- Package Integrity Test
- Shelf-life study design
Who Should Attend?
- Medical device manufacturers
- Raw material suppliers
- R&D scientists
- Quality assurance managers
- Regulatory affairs managers
- Packaging material manufacturers
- Packaging material suppliers
Course Fee: Free on invite basis (limited seats).
Where: UL Quality Assurance Pvt. Ltd, A-12, Infocity 1, Sector-34, Gurugram-122001.
Click the link to register: http://connect.ul.com/Biocomp-Packaging-Gurugram_LP-Reg.html