Well, if you have an approved product or you are trying to get a product approved, you're going to get inspected. The depth of the inspection is always going...
I live a few blocks from the FDA, and while I have never worked there and I don't personally know anyone who does, I hear about the general issues for the...
Finally GAMP 5.0 document is available to download at www.ispe.com. Anyone had a chance to review the content?. Any significant difference from GAMP 4.0...
All, Thanks again for the quick response and all of the volunteers! Now for the tough stuff. What we need is some brave soul(s) to do a little "internal...
I concur. FDA plays a valuable role when allowed to do their job. I personally am glad that clinical trials are performed, black box warnings are assigned...
Young, Loretta
loretta.young@...
Mar 3, 2008 4:28 pm
17655
ISPE published a GAMP 4 to GAMP 5 summary which is accessible for free o nthe ISPE.org web site. Carl ... [Non-text portions of this message have been removed]...
At the GAMP5 launch, speakers said that ISPE is doing some work on having a uniform system or process for electronic documents. GAMP5 is only available on...
I Just spoke to a customer service rep. The e-purchase will be available later today (I was told) but I am not sure if it will be electronic versions or just...
Haven't you heard? The government only messes things up and free market economics will solve all of our problems!!! Okay, now that I am done laughing, I agree...
Begin rant. In this forum there's lots of great advice and opinion. Funny thing is that from my personal experience (emphasize MY experience) the quality you...
One of the reasons the current system is aimless and toothless is that the regulatory mandate has been far too broad for any single unit to look after. If I...
<snip> In recent years, the political forces at work in Washington DC have pushed the pendulum away from regulation and more toward an anything goes attitude....
I think all companies know how it should be done. The reality between that and what can be done is different. And in a lot of companies the people making those...
It's called risk assessment and prioritizing. Management doesn't know everything and that's why we have jobs. Also, this is why the FDA has reformatted...
Put more police officers out on the road and people slow down (at least when they are nearby). The industry will react to the level of enforcement or the lack...
Is the data (patient results) generated by the medical device considered to be e-records, and therefore required to comply with the 21 cfr Part 11? In other...
Dear Rant, My experience mirrors yours. I think the root cause for this is that management in industry simply does not perceive the true risk that is caused...
Did anyone attend the conference where they did the GAMP5 rollout presentation? Any report? At Your Service, Thomas Quinn, CISSP President, The Hollis Group,...
Review text and the exam are offerred by the Regulatory Affairs Professional Society (RAPS). www.raps.org RAPS, local chapters of RAPS and other professional...
We’ve literally built an industry around a reg that’s in limbo now. People were hired, jobs were created, but the cat (FDA) has left the building. And...
Siegfried, That's a little unfair. The ISPE use a service by Techstreet for their secure document delivery and it works fine. I find it a very reliable and...
I can tell you Jeff we continue to do risk assessments and we do prioritize. We also continue to educate and try to improve the systems. I certainly was not...
Andy, lucky you That was not quite my experience with a locked down laptop. Instructions from Thompson were: disable the firewall to enable download (I am ...
Short answer: NO Longer answer: Part 11 is intended to be used for devices covered by predicate rules (ie 820). These predicate rules are all associated with...
Please clarify the following situation. A laboratory instrument acquires data, process the data, and prints the report for reporting of information used to...
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