GAMP 5: What to expect!

MEDICAL DEVICE 21 CFR PART 820 (The Regulations)
1

Hi All,

For those that haven’t already seen it, there is a presentation
currently available on the web from George Smith of the FDA about the
past, present, and future of Part 11. It’s from an ISPE conference in
2006 so is pretty recent and may wet your appetite until this most
recent presentation becomes available.

http://www.labcompliance.com/documents/FDA/Presentations/e-records-part11/g-328-georgesmith-06-03-part11.pdf
http://www.labcompliance.com/documents/FDA/Presentations/e-records-part11/g-328-georgesmith-06-03-part11.pdf

2

He gave the same speech with the same slides in September of 2005. see attached power point.

George Smith FDA.pdf:
Your file of 274.4 KB bytes exceeds the forum’s limit of 19.5 KB for this filetype.

PM me and I will send

3

it is good from ISPE

4

It’s my understanding that preparation for GAMP5 is already in progress (a preliminary draft is to be issued in mid-2007; a final draft is expected in 2008).

Can anyone confirm this?