Company: Grand RapidsDate: 10/1/01 Product: Thumper cardiopulmonary resuscitator Your response to FDA-483 point #6 regarding 21 CFR Part 11 – Electronic Records is not adequate as explained in more detail below. 21 CFR Part 11 During the FDA inspection it was discovered that electronic records are used to establish the firm’s Complaint Files, 21 CFR...Read More
Upcoming Public Courses
No public courses are planned at this time.
If you would like to discuss a private, onsite course, please fill out the form below.
