The EU Medicinal Products GMP contains an Annex (11) on use of computerized systems. This annex identifies requirements for validation, electronic records, and use of third party software. In some instances it is more specific than FDA requirements. The new version at the link provided obsoletes the Dec 1998 version when it becomes effective June...Read More
This content is only available to our Standards Navigators subscribers. See our Subscribe page for information on subscriptions. Read the Swedish formal objection to the harmonization of ISO 13485. Sweden Formal Objection ISO13485 Medical DevicesRead More
This content is only available to Standards Navigators subscribers. See our Subscribe page for information on subscriptions. The Industry response to the Swedish objection to ISO 13485 can be found at the following link: Industryresponseto13485objection I had previously posted regarding the Swedish objection at this link: Read More
Need Your Input!
We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course? What are the least favored (not workable) months?