Hopefully we can continue on from here. Sorry about the interruption.

Originally posted by Marc
Hopefully we can continue on from here. Sorry about the interruption.

What did I miss, there seems to be some postings missing???:confused:

Yes, you are right IG. There are posts missing... See THE LATEST NEWS in the streamer at the top of the page for further info.

/Claes

Is the Jim = Tom = Nosmo thing or did he pull some other crap as well?

Originally posted by Claes Gefvenberg
Yes, you are right IG. There are posts missing... See THE LATEST NEWS in the streamer at the top of the page for further info.

/Claes

Claes-

I see the streamer, but I know there are also posting missing from this thread I was wondering what happened???

IG

Posts are not all that has vanished.

Look on the members list for Jim Wade, Tom Harris, and Nosmo King.

Don't know if it is related, but the Cove was down for some time over the weekend. Then, there's the "Latest News". I can't tell you for sure, but I think the split personality thing might have been the least of the transgressions...

1 or 2 of my posts are missing, too. I assume that they were removed because they were part of the bashing going on at the time. Personally, for the sake of peace, that's OK by me.

I have never seen Marc "take sides" during the rare (yeah, right) bickering that occurs here from time to time, so I assume that there is a lot more going on than we see. Besides, as has been pointed out before, its his sandbox, and what a sandbox it is.

Life goes on.

Craig

Originally posted by Mike S.
Is the Jim = Tom = Nosmo thing or did he pull some other crap as well?

Mike S.

So as not to de-rail this thread, let's move it to the "Terrorism" thread.:p :smokin:

No worries Energy. This particular thread was well and truly derailed already. I can understand that considering the recent events.

Originally posted by ISO GUY
Claes-

I see the streamer, but I know there are also posting missing from this thread I was wondering what happened???

Ah, ok. You'll have to ask Marc about the details, but to make a long story short: All of a sudden bashing, caused by the Jim = Tom = Nosmo business started popping upp all over the forums, and in this thread in particular. Marc decided that it was enough, put the site on hold, booted Jim, flushed some posts and rebuilt the database. If there is more, I don't know about it.

I also want to add a request: Let's get back to the business at hand...: Exchanging information and ideas and learning from each other.

/Claes

Sorry I just noticed, but hats off to forum news being displayed in the banner above the login feature. Outstanding!!!

Al...

Claes:

I agree, let's move on.

The fact is, with respect to your first post on this thread, we as Quality Professionals, are about to get overwhelmed with questions. Lets make sure the site is strong, and help our fellow, Cove deprived, Quality Professionals (they Will do a Google) get where they need to be. NOT to be registered, but to make their company better.

If anyone has felt that I acted badly in the recent troubles, email or PM me. Let's talk.

This site was instrumental in getting my company on the ISO2K bandwagon. Now its time to learn from others' questions, and try to help.


Craig

I have to apologize I was guilty of JW bashing. I should not have done it and I let it get the best of me. I agree lets get back to the question at hand. :truce:

You were not alone IG...

Ok, this is how this thread started out. On we go:

Originally posted by Claes Gefvenberg
I have posted this poll once before, earlier this year. I believe it's time for an update: What is your current situation concerning the transfer to ISO 9001:2000? The deadline is looming.

Current situation in Sweden:

Appr.4700 companies certified acc to ISO9001. Certifying bodies claim that appr. 30% of their customers have upgraded so far, and fear that they may not have the resources to take care of the stampede when it begins...

How about you?

We will not transfer
We have not started
We're working on it
Done it...

/Claes

I split these off from the original thread. The purpose of this site, and has always been, to share information. Over the last 2 years I let the site get away from me. In large part the properties of the forums software allowed this. But the over riding factor is that I got busy and neglected what was going on.

I deleted all posts by Jim Wade. I did so with hesitation as Jim did post some good information and arguements. On the other hand, Jim was here more often than energy and Al Dyer, which is saying a lot. Many of Jim's posts were laced with links to his site which was tolerable to some degree, but it was coming to a point where I really didn't appreciate it.

However, things took a turn where Jim took things to the nth degree by using multiple e-mail address and identities and was essentially baiting people. That, along with his general demeanor, formed the basis of my decision to eliminate as many traces of Jim as I could. Unfortunately, when I deleted Jim's Nosmo and Tom accounts I failed to delete associated posts first so many of those posts still exist.

Now - the future. In the future I will ban people who start personal attacks or bait people. My expectation is that in the 'business' end of the forums folks will be civil. I expect Al to stop with the cuss words and that goes for everyone. If you want to play around there are the forums under the 'Odds and Ends' group to play in.

I have asked the moderators to let me know if they see any trouble. They can act themselves or they can notify me.

However -- Anyone can let me know - each post in every thread has a 'Report this Post to a Moderator' link. It's fast and easy. Use it!

Too many people are reading others opinions and taking them personally. I just cannot tolerate this in the 'business' end of these forums any longer.

Thoughts of the week:

"Plays well with others...."
"I'm a professional. I'm above participating in verbal assualts."

Originally posted by Marc
On the other hand, Jim was here more often than energy and Al Dyer, which is saying a lot.

We're here because we love you!;)

Anyway, my previous place of employment has laid off again. As most of you know, they canned the ISO effort and me. They are now pursuing GMP. I believe it is Good Manufacturing Practices?. My understanding is that this "System?" is widely recognized in the Pharmaceutical industry. That it is, in some ways, more stringent than ISO. Any thoughts on their accomplishing this with less people, no Consultants and a total failure at implementing the basics of ISO, except on paper. Any experienced GMP practioners out there? :smokin:

I didn't say it is bad. just said you two live here....

Anyway, you might want to start a new thread in the appropriate forum with regard to GMPs. I can't recite the history but there may be a couple of GMPs. The one I remember was from the Navy - some admiral - back in the late 1970's *I think*. I know there is a 'modern' set of GMPs which, as you state, are associated with the pharmaceutical industry.

Energy:

Try the FDA and medical Devices thread.

GMPs Good Manufacturing Practices are also associated with medical devices. The government regulation is 21cfr820 also referred to as the Quality system Regulation (QSR). The pharmaceutical gmps are in a different part.

You can find either by doing a search at this site
code of federal regulations (http://www.access.gpo.gov/nara/cfr/cfr-table-search.html)

Perhaps we should move future discussions to the appropriate forum/thread.

Originally posted by Al Rosen
Energy:
Perhaps we should move future discussions to the appropriate forum/thread.

Because this thread was about ISO, basically, I simply asked if anybody, with the right experience, thought GMP was as difficult to obtain/comply with as ISO. Look at my original post on this subject. Marc suggested I start a thread on it. Personally, I hope my ex-employer falls right on their deceptive faces. Wish them all kinds of luck. Just not the right kind. Aww-Fugettaboutit.:agree: :smokin:

I would rather face my ISO registrar/auditor than an FDA Inspector.

The QSR/GMP is harmonized with 9000:1994 but is more proscriptive. It's the government regulating.

GMP/ISO very similar, GMP does have a few more requirements, is it harder to comply with GMP than ISO IMHO I would say no.

AL was right, I would rather have an ISO audit than and FDA inspection. The one thing with FDA is depending on your product or service will dictate how often you see them. I know some companies that have never had an FDA inspection and others that see them every year. They will make sure you are crossing your t's and doting your i's.

I may be wrong but Pharm GMP is 21 CFR Part 58.

I recently worked with a company to merge GMP 820 with ISO 9K2K. 820 is bulit around 1994, but with a few differences. It wasn't too hard to comply with both.

As a side note, this company was a medical computer company. It had the rigidness of a medical company combined with the loosness of a software company. Quite unique and fun!

I hope my ex-employer falls right on their deceptive faces

Now Bill, you must move beyond your pain and anger. Until you do, your past employer still has you. Breath deeply, go fishing and release the chains of your past. You can be free, grashopper, you can be free! (although you do have the right to charge for your services).

The pharmaceutical gmps are in 21cfr211.

I know we're a long way away in Oz, and as significant as ant snot (except for swimming, sailing, cycling, golf, etc - any sport with the word WORLD in it that includes participants from outside of America really), but have you heard about PAN PHARMACEUTICALS?

This local company went BANG over-night when it was discovered that they weren't following their own procedures, weren't complying with legislation, in fact they fudged lab results so everything appeared sound when they were audited by the TGA/FDA (who ever the **** it is).

They made an enormous range of products from vitamins to prescription drugs. And they made them under label for other manufacturers and distributors. The distributors have the some product manufactured by different companies in the same containers, and aren't required to disclose the manufacturer on packaging. Thus the distributors using PAN as a supplier didn't know PAN product from non-PAN product, and had to pull the lot off of shelves across the country.

I'm glad that's one company that doesn't appear on my CV.

Originally posted by db

Now Bill, you must move beyond your pain and anger. Until you do, your past employer still has you. Breath deeply, go fishing and release the chains of your past. You can be free, grashopper, you can be free! (although you do have the right to charge for your services).

I have a couple of fishing buddies there and do not really wish financial harm to them. I won't forget Christmas of 2002, though. This company makes equipment that purifies water for some Pharmaceutical companies. It's interesting that they think that this is obtainable. Probably because there is no Internal Auditing to a standard? No training? No evaluation of competency? I'm surprised, that's all. If it's in synch with 9004, non mandatory guidelines, it may be easier to pull off. Anyway, Dave, time heals all wounds. The scars remain. Thanks all for the insight. Back to topic?:agree: :smokin:

Originally posted by db

Now Bill, you must move beyond your pain and anger. Until you do, your past employer still has you.

I just have to post this. When I got the hammer, there were 50. 4 more made it 45. They just did another 15. Oops. We're down to 30. They can kiss my grits. Sorry. Didn't mean to sound so vindictive!:p :smokin:

I was "downsized" by a company several years ago. I'm sorry to say that I took great pleasure in the fact that not too much later the induhvidual responsible for me losing my job was sacked, and I came back as a consultant (OK, you're right - I'm not sorry). I have done a fair amount of work for them since then, and this week they are going through their ISO 9001:2000 upgrade audit. :D