Packaging Validation of Medical Devices – Impact of the Revisions of ISO 11607 & Suitable Strategies
The medical device industry is a fast changing environment that is continuously adapting to the constant challenges within the medical landscape. One such challenge is designing an evaluation plan for fulfilling the requirements for a suitable and validated packaging system using package testing that will comply with FDA or international health and safety regulations. The webinar will mainly focus packaging systems for sterile products; however, several test models are suitable to be used for packaging of non-sterile products.
During this webinar, our experts will provide:
- An overview of different testing standards;
- The status and expectations of the FDA;
- Discussion on the new international standard ISO 11607-1 and -2, which will be issued soon.
As the revised standards will be immediately valid after publication, manufacturer should be prepared regarding the changes of the revised standards as compared to the previous documents in order further supply sterile medical devices meeting the new standards.
Who should attend?
Managers, directors, engineers and scientists responsible for research and development, product development, quality assurance and regulatory compliance.
View our Past Webinars
- Chemical Characterization and Toxicological Risk Assessments: A Smart Approach to Biological Evaluation
- Sterility Validation 101: Ensuring a robust sterilization validation program from start to finish
- Biocompatibility Testing of Combination Devices - New Regulatory Guidance
- Developing a Comprehensive Tool Kit for Microbial Identification
- Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies
- Best Practices for Extractables and Leachables Testing