T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

21 CFR part 11 Update

Posted by tjkuhn on February 27, 2009

Folks, it looks like some of our US regulations and guidance documents have been flagged for update by FDA….including everyone’s favorite, 21 CFR part 11 (source Cerulean’s email newsletter). I don’t anticipate major changes, just clarification on their intent.  Everyone enjoy your Friday.

New Guidance Agenda for 2009 Released by FDA

The FDA’s CDER has published its list of expected guidance documents and revised regulations to be issued this year (2009).

Readers of our 2009 forecast will find many items on the list familiar:

· 21 CFR Part 11

· Process Validation

· Adaptive Clinical Trial Design

· Contract manufacturing

· Various marketing, promotional and labeling guidance

· “Dear Healthcare Professional Letters” for recalls



2 Responses to “21 CFR part 11 Update”

  1. TJ, I’m flattered that you included this on your blog.

    If you’d like, I’d be more than happy to put you on my “keep me up to date on new publications and events by Cerulean” list. You won’t get more than an email or two a month, but it might be of interest to you see recent articles, etc.

    Let me know at your convenience. john


    • tjkuhn said

      Hi John,

      Thanks for stopping by. I just saw your comment now (over a month later) as it was hung up in my queue. I’d very much like to be on your list. Best,



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