As the medical device industry shifts toward more ethical and sustainable practices, the transition away from animal testing has become a pressing priority. The recent updates to USP Class VI (Section <88>) testing standards reflect this evolution, offering new guidance that significantly impacts both manufacturers and suppliers across the healthcare ecosystem.

This webinar will provide a comprehensive overview of the changes to USP Class VI, with a focus on the implications of eliminating animal testing and a new claim as pharmaceutical grade plastics in materials used for medical devices. Experts will break down the regulatory nuances, testing methodologies, and practical steps needed to remain compliant while embracing animal-free alternatives. Whether you’re involved in product development, quality assurance, or regulatory affairs, this session will equip you with the knowledge and strategies to successfully navigate the updated requirements.

Key Learning Points:

• Understand the Evolution of USP Class VI: Learn what’s changed in the latest updates, particularly around testing requirements.
• Compliance Pathways: Discover how to align your materials and processes with the new USP expectations and claim materials as pharmaceutical grade.
• Testing and Certification Strategies: Get clarity on testing protocols and documentation to ensure your products meet the updated USP Class VI criteria and new certifications.
• Impacts on the Supply Chain: Understand the upstream and downstream implications for suppliers and manufacturers—and how to communicate effectively across the value chain.
• Future-Proofing Your Products: Learn how embracing animal-free practices not only meets compliance but also supports sustainability, ethics, and global market trends.

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We serve over 3,000 customers across 12 facilities in the United States, Mexico, Asia and Europe. With a comprehensive array of over 900 laboratory tests and the expertise of Regulatory Compliance Associates, a recognized leader in life science consulting, we support our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.

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