Who Should Attend: This is a recommended annual training course. It is designed for anyone who works at a biopharmaceutical firm. Senior, junior, technical, administrative, regulatory, manufacturing doesn’t matter. We should all know the rules and hear why they are important and how they are currently being interpreted.
Click on the titles below to learn more about each session. When live sessions are available, sign up anytime and receive links to recordings of any individual sessions or all eight sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course.
Each 90-minute session is just $362 per session or $2898 for all eight sessions! Great group discounts are available.
FREE EXCERPT! Want a preview of Session 1 from the GXP Course?
Click HERE to watch an excerpt from Session 1 anytime.
Content:
● PHS and FD&C Act, FDA structure and its relationship to drug life cycles (development thru post-marketing)
● Rules…Regulations…Guidances: What and Where
● GMPs 210 and 211; The Subsections A – C: Including organization and personnel; training issues, and facilities
Content:
● Anatomy of an FDA Inspection
● Review of past years inspection trends
● In-depth look at the top 4 inspection issues
● Case studies of current 483s and warning letters
COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.
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