Training Video on Pharmaceutical CAPA and Uncorrected Errors

[Alain]

I am writing and will be delivering a presentation on CAPA for the pharmaceutical company I work for.
Can anyone direct me to a short video dramatizing the consequences of not correcting and preventing manufacturing errors. I would also need to know where I could find some real life examples of uncorrected errors that led to serious problems to a company/product/public.



Alain

 

[Al Rosen]

Are these helpful?

Ford Pinto Fuel-Fed Fires

(broken link removed)

Some disasters attributable to bad numerical computing

 

[Alain]

Thanks for the quick answer Al!

Good examples with pretty serious consequences, would be great to have some drug errors as well. I will try google or dogpile.
Any place I could find a video on this?

This bulletinn board is amazing! I've been browsing through the different Forum topics. The conversation and the information available is impressive and practical.



Alain

 

[Al Rosen]

Thanks for the quick answer Al!

Good examples with pretty serious consequences, would be great to have some drug errors as well. I will try google or dogpile.
Any place I could find a video on this?

This bulletinn board is amazing! I've been browsing through the different Forum topics. The conversation and the information available is impressive and practical.



Alain

Try searching on phamaceutical product liability. Here are some.

Also try (broken link removed)

 

[AllanJ]

Good examples with pretty serious consequences, would be great to have some drug errors as well. I will try google or dogpile.
Any place I could find a video on this?



Alain

Though it is a personal view, few pharmaceuticals incidents are more scandalous than Thalidomide in the 1960s. The victims still live with the appalling consequences. I cannot think it is "great" to have drug errors.

There have been recent suggestions that Thalidomide ought to be release again but for alleged benefits. I find that highly alarming.

 

[QA7458]

Re: Seeking Training Video on Pharmaceutical CAPA and Uncorrected Errors

These are older incidents but they show why cGMP controls were put in place and are a good example of the consequences of not complying with cGMP.

Critical drug/medical product incidents and the resulting legislative responses (introduction of cGMP regulation):-

Apologies - I can't post links at present, you will have to cut and paste the further reading links into your browser.

Location/date - U.S.A./1938
Incident - 107 people died (mainly children)
Cause- Cough medicine contained diethylene glycol
Response – Food, drugs and cosmetics act
Further reading en.wikipedia.org/wiki/Diethylene_glycol#Mass_poisonings_attributed_to_DEG

Incident - Thalidomide tragedy 1962
Response – The medicines act 1968 and orange guide (Rules and guidance for pharmaceutical manufacturers and distributors – UK)
Further reading - en.wikipedia.org/wiki/Thalidomide#Side_Effects:_Birth_Defects

Location/date – UK (Devonport Hospital)/1972
Incident – 6 deaths due to contaminated IV fluid
Cause – Failure of terminal sterilization due to manufacturing faults

Location/date - U.S.A./1976
Incident –10,000 injuries (FDA report)
Cause - Faulty medical devices
Response – The medical device amendment 1976

Date - 1968
Incident – Therac incident, programmable radiation therapy killed 6 people
Cause – Software programming problem
Further Reading - en.wikipedia.org/wiki/Therac-25