This webinar provides a basic overview of considerations for establishing a test strategy and test plans for biocompatibility, sterilization and packaging of health care products. We emphasize the importance of this being done early on in the process. We will provide examples of some of the common mistakes which we have experienced regarding test strategies and plans over the years in working with health care product manufacturers. We will review the importance of developing a strategy which includes proper rationales and the involvement of scientific and regulatory experts. Lastly we present a practical example of developing a biocompatibility testing strategy including implementing rationales and test choices. The information in this webinar is based on the combined 33 years of industry experience of the presenters and is intended to help make the regulatory submission and testing processes as smooth as possible.
This webinar is intended for the following individuals:
- Product development engineers
- Quality engineers
- Regulatory specialists
- Those responsible for biocompatibility, microbiology and sterilization
- Those responsible for early stages of product development