Thanks Jim for starting this blog. We have had many discussions in the past about advancing ideas for networking, building relationships and our careers. Check out www.cgmps.com - my wife now owns it and she is driving this site. Lets get some of our past ideas rolling and turned into action - I firmly believe there is information overload in the biopharm industry and that a small group of individuals, possibly the ones using this blog, will and should lead efforts in the industry to establish clear and concise methods for establishing better work processes - some of which are outlined on www.compliancebasis.com.
First off, I would like to assemble a group of people (no more than 5) for publishing a white paper on the GMP Design Reviews and Type C Meetings with the FDA and GMP Guarantees from A/E firms. Is anyone interested?
Friday, February 11, 2005
Thanks Jim Duffy
Subscribe to:
Post Comments (Atom)
4 comments:
not to start quibbling, but how does an A/E provide a GMP guarantee when this issue is impacted by actual operation to the extent that it is?
Does the guarantee still mean anything if it starts having qulaifying clauses, or can this still become an acknowledged industry standard???
You're asking a private company to guarantee the actions of a notoriuosly fickle public agency...
and who is paying the fees that would justify taking on this risk?
Operating companies are buying on price...do you see this as "value added"?...a boring comment but, nontheless,you get what you pay for...
You're asking a private company to guarantee the actions of a notoriously fickle public agency...
and who is paying the fees that would justify taking on this risk?
Operating companies are buying on price...do you see this as "value added"?...a boring comment but, nontheless,you get what you pay for...
Second comment- this appears to be 2 separate topics...let's pick one...I suggest the Type C/ Design Review Meeting topic...
I'm thinking we post an outline in a post and go from there...
Post a Comment