IOPP recognizes that there are not a lot of educational materials, either coming from industry groups or within individual organizations.
So IOPP has decided to “reboot” the medical device technical committee to drive development of a new course they hope to launch in Chicago at PACK EXPO International next Fall.
Goals for this meeting, included:
Invite Involvement (beyond engineering to quality and marketing)
Drive Collaboration (between mfrs. as well as suppliers)
So far, the Fundamentals course includes nine components, but IOPP made it clear there will be additional elements added like labeling, etc.
Regulations, quality systems and standards
Materials and their forms (packaging and labels)
Design (inputs, risks, outputs)
Processes (sealing and sterilization)
Testing, validation and qualification
Troubleshooting CAPAs (corrective and preventive action) & remediations strategies
If you are interested in contributing to the discussion, contact Danette Casper@edwards.com.