This webinar will provide an overview of the medical device packaging process from conception to testing by examining three critical elements of any medical device package validation plan:
1. Answering the question, Is it necessary to have a documented validation plan before testing begins? This includes touching on prototype design, raw materials, and product interactions with packaging.
2. Review of regulatory requirements for a documented validation plan, and key points to consider when designing, manufacturing, sterilizing, and testing your packaging validation plan. We will also explore the protocol and define what worst case means.
3. Look at possible test methods for validating your packaging, and discuss what would require a re-validation or at the very least documented justification.
This webinar is designed for individuals with minimal experience in the medical device market, who are unsure where to begin the medical device packaging process. Participants are encouraged to familiarize themselves with ISO 11607 parts 1 and 2 along with TIR 22.
