I believe I said you need to determine how critical the product is to Your functions as the first step? I much appreciate the discussion, thank you. Paula -->...
Paula Wehmeyer
paula@...
Jun 2, 2003 2:16 pm
8596
Fitquest: As part of your overall audit strategy, each and every vendor must be objectively evaluated to determine their supply of services or product that ...
Jonathan Andrus
jrandrus@...
Jun 2, 2003 2:16 pm
8597
IF you need to perform a vendor qualification there are ways other than an audit to do this, however, if it is possible to go on site, and feasible, then this...
Michael, My responses are interspersed. Thank you. --> Paula, --> I respectfully and strongly disagree. You described a --> current commonly --> used...
Paula Wehmeyer
paula@...
Jun 2, 2003 2:17 pm
8599
It would seem that the use of the drawings in electronic format is what is the Part 11 issue. You can state that everything is paper- based but the fact that...
Hi: I have to attend an interview which requires the foll skills "GMP background and Knowledge of Lab procedures" Can some one pls. help me in knowing what...
I am really confused by this!! If you had a GMP background and knowledge of Lab procedures - which would appear to be a pre-requisite to doing the job -...
Graham Tinsley
Graham_Tinsley@...
Jun 2, 2003 6:17 pm
8602
Hello All, Can anyone provide advice on whether internal elearning systems installed within a Pharmaceutical organization require electronic signatures? I've...
Hi! Can I get some questions and tips what the clients might ask on Analytical Lab Validation for Clean rooms and HPLCS systems (HP/ Agilent, waters etc., ) . ...
<pedantic mode on> There are no electronic signatures required by the FDA. If, however, you choose to create, maintain, archive etc etc electronic records ...
thnaks if you can throw some light on lab procedures this would help Graham Tinsley <Graham_Tinsley@...> wrote:I am really confused by this!! If you had a...
21CFR11 requires use of electronic signature if you are replacing a hand written signature. Note: Only Username and password is not a suffient use of...
If the predicate rule requires a signature by, for example, the quality unit, and you are using an electronic system, then an electronic signature may be...
Jonathan Andrus
jrandrus@...
Jun 2, 2003 8:47 pm
8608
I will take a stab at this.... If there is a predicate rule which is applicable to the system (a CFR regulation that you are subject to that talks about...
Graham Tinsley
Graham_Tinsley@...
Jun 2, 2003 8:47 pm
8609
Paula, Thanks for taking time to respond. I understand your suggested use of the questionnaire better now and appreciate the education. I generally support...
"if a record is required to be maintained by a predicate rule and you use a computer to generate a paper printout of the electronic records, but you...
Patrick, Allow me to back up Graham's comment. At www.hollisgroup.com/download.htm is the file "210-211-sigs" (way down at the end of the list) that recounts...
Thomas Quinn
tquinn@...
Jun 3, 2003 2:59 pm
8612
Graham, Not so fast, there buddy! Here's an interesting nit... (Gee, I get to put on my "Professional Witness" suit.) Actually, 21 CFR 211 states: § 211.25...
Thomas Quinn
tquinn@...
Jun 3, 2003 3:00 pm
8613
There is no requirement that I've seen in the US, Canadian, or EU GMPs for a signature on a training record. The closest you'll get is something like ...
James Vesper
jvesper@...
Jun 3, 2003 3:01 pm
8614
Graham, OUCH, that hurt. But as a friend once said, "There mighten be a grain of truth in that there pain." Terry ... would appear to be a pre-requisite to...
Do you really have the required background or are you just trying to give the appearance of having the background without actually being qualified? Remember...
Reedinger, Erik
erik.reedinger@...
Jun 3, 2003 3:02 pm
8616
Darn it all....diplomacy was never my strongest skill ;-) Thanks Erik for writing the answer more eloquently Graham ... From: Reedinger, Erik...
Graham Tinsley
Graham_Tinsley@...
Jun 3, 2003 3:58 pm
8617
<<Therefore, one could make a reasonable argument that your (somewhat cynical, I presume) observation that some companies will hire just about anybody while...
Graham Tinsley
Graham_Tinsley@...
Jun 3, 2003 3:58 pm
8618
Now Graham, don't let your blood pressure get to high. We all start somewhere. Kind Regards, Michael ... From: "Graham Tinsley" <Graham_Tinsley@...> To:...
Now if you boys don't stop fighting you'll have to go to bed without your dinner. I just read'em and reply where I can. Sticks and stone, sticks and stones....
Perhaps we could cut this person a little slack. Do we really belive he is saying "hey all you out there in pharma-land, tell me how to cheat in my...
Super Duck
super_duck@...
Jun 3, 2003 8:02 pm
8621
CAUTION: Remember that the Scope of 21CFR 211 states that it contains the MINIMUM current good manufacturing requirements and also remember that the...
SOMETIMES THE BEST WAY TO FIND OUT WHAT THE LAB PROCEDURES ARE ALL ABOUT IS TO LOOK AT YOUR COLLEGE NOTEBOOKS AND UNDERSTAND THE PROCESS TO WHY THE TEACHERS...
In light of the subject line above, I will attempt to be constructive here: As someone who has hiring responsibility, the question posted irks me as you may...
Reedinger, Erik
erik.reedinger@...
Jun 4, 2003 2:32 pm
8624
Bravo!! I will echo what I shared outside the forum to someone who was surprised and possibly quizzical about my rather cynical and abrupt response to the...
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