FDA - READ THIS : QUALITY ISSUES ARE BAD IN NOVARTIS

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Too bad I stayed home this morning and could not see the faces of my colleagues, nor hear their comments...

As this morning we got the boss's SPIN on the inspection....and spin it is !!!
wow...Patrice, you can really spin anything into something ! You got the Midas Touch !

Major findings from the inspection speak of a culture of total disregard to Quality and Compliance. EMEA found poor quality controls in case processing; and CAPA commitments, impact analysis. In addition, poor management of local Risk Management Plans, incomplete unblinidng of studies, lack of retrospective reconciliation of ADRs, ect, and ect....

And that was after 3 weeks of us working like slaves, 24/7 in order to mop the house, dust all the cabinets, and shred all the evidence.....

What a SPIN !!!
He must be a DJ on Crack to spin so good !

The truth....we suck at Quality and Compliance - because all Sr Management cares about is timelines, pipeline and meeting the numbers.
 






The EMEA inspections are weak and won't actually shut anyone down. They will slap you hand, but let you keep on keepin' on.

Meanwhile, the above mentioned findings are accurate and desperately need to be addressed. Sadly, action will only occur when the FDA threatens to stop shipments through a warning letter or other method.

Good luck with all that. Someone will have to take the hit...so stay out of the crosshairs! Best method is for everyone to agree in advance who to blame and then when the brown stuff starts flying all of the fingers will point to the same person. Who should we select and on what basis?
 
























i am embarrased to be part of this company
these compliance violations have been piling up - and our senior management has consistently ignored them, at all levels : CPO, Region and Global

and now...they are pushing and pulling everyone to correct the mistakes

i am seriously thinking of leaving - just wish there was an offer...any offer to jump ship
 






Anonymous said:
Want to know ?

These are the facts:

2 First-Time Clinical Protocols were NOT filed with the FDA as required.
In addition, 5 Clinical Trial Extensions were NOT filed, either.

16% of Protocol Amendments were NOT filed.... that's a whopping 219 Amendments !!!

10% of all Investigators were not checked - that's 1041 investigators....bet some rotten apples were among them.

and 70% of ALL Transfer Obligations were not filed ( or 359 of these !!! )

Were Patients hurt ?

YES.

For example, in one case:
SOPs for Protocol Interactive Voice Response System were not followed.
As a result, during a trial, patients were started at a higher dose, kept at a higher dose, and not titrated downwards.
These group of patients, who trusted Novartis with their lives, experienced Adverse Events which would have been totally avoided if, if, if....someone would have care enough to follow the Standard Operating Procedures.

Why all this happenned ?

Because, all the focus have been in "speed" ,"innovation", "LEAN"....

What are they going to do about it ?

JAJAJA...running like headless rats to "dot the i's and cross the t's"...
and on August 30th, our "fearless" senior managers are meeting with the FDA to BEG FOR MERCY....and show them all the nice things they have done to remedy the situation.

Oh !
Forgot to tell you.....obviously, some heads will roll in the process...
Many heads will roll
Unfortunately, those managers who are truly responsible for the problem are not only staying, but getting promoted.
Click to expand...

Just the tip of the iceberg.

"Reuters, July 15, One fly in the ointment, however, was that Novartis' cancer drug Afinitor failed in a late-stage study in advanced carcinoid tumours"

just wait and see
 






Anonymous said:
Want to know ?

These are the facts:

2 First-Time Clinical Protocols were NOT filed with the FDA as required.
In addition, 5 Clinical Trial Extensions were NOT filed, either.

16% of Protocol Amendments were NOT filed.... that's a whopping 219 Amendments !!!

10% of all Investigators were not checked - that's 1041 investigators....bet some rotten apples were among them.

and 70% of ALL Transfer Obligations were not filed ( or 359 of these !!! )

Were Patients hurt ?

YES.

For example, in one case:
SOPs for Protocol Interactive Voice Response System were not followed.
As a result, during a trial, patients were started at a higher dose, kept at a higher dose, and not titrated downwards.
These group of patients, who trusted Novartis with their lives, experienced Adverse Events which would have been totally avoided if, if, if....someone would have care enough to follow the Standard Operating Procedures.

Why all this happenned ?

Because, all the focus have been in "speed" ,"innovation", "LEAN"....

What are they going to do about it ?

JAJAJA...running like headless rats to "dot the i's and cross the t's"...
and on August 30th, our "fearless" senior managers are meeting with the FDA to BEG FOR MERCY....and show them all the nice things they have done to remedy the situation.

Oh !
Forgot to tell you.....obviously, some heads will roll in the process...
Many heads will roll
Unfortunately, those managers who are truly responsible for the problem are not only staying, but getting promoted.
Click to expand...

hmmm
 
























most of you sound like all you have are hammers in your toolbox cause you're treating every thing like a nail. Get back to work & just be glad you have enough free time to read cafepharrma. It's not the huge nuclear meltdown some people suggest. A mess yes but not a crisis or disaster. Calm down.
 






























All true. This weeks staff meeting in my group highighted the tales of our lack of compliance. Onco is in deep doodoo. Internal CQA audits found that there are also problems in Genmeds, but not to the same magnitude as Onco. CQA and DRA have installed defibrillators incase of an emergency....its bad. I guess onco will not be the special place it used to be. They will now be required to follow SOPs like the rest of NVS. Can't use the burocratic excuse of the past to speed things up.

Novartis is planning to come clean with the FDA. Don't know when but management better take the jet there and fast before the FDA gets wind of it. Believe me Sr. management has been told to go and represent, and they are going to bend over and beg for forgiveness. The oversights in quality and lack of following SOPs and regulations are unbelieveable from what I heard. Its as if preschoolers were running these clinical programs instead of professionals. Due to this disaster, jobs are being created under the term "quality". Each TA will have heads of quality assigned and will start building a staff to monitor and clean up the mess. This is all a roost to provide details to the FDA that we know we F'ed up and this is the plan....see aren't we a good company.

I agree with the posting about spin master DJ Patrice. He can spin anything. Its amazing he hasn't puked from vertigo. And watch out for the red haired clown who heads up MSO. Shes like teflon blames everyone for her incompetence. She blamed the sales organization for not following RMP implementation when the Health authorities came down on the recent exjade disaster. Can't wait until someone sees her true colors and the ax falls on her.
 






...if there is someone to blame is the Head of Development....for NOT PAYING attention to the quality issues....

When is Epstein going to change Management in Development ?

I bet he is waiting for the approval of the MS drug, before pulling the plug on Mundel.

BUt it might be too late....
 












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