Towns Questions Johnson & Johnson
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A "voluntary recall" is a "step" in the right direction.
Recalls are not a "means" of determining product "quality but are a means to determine "inadequate quality". If the company does not "fix" the problem, they will consistently have problems. In turn, the “consistent problems” shows a problem validation.
The foundation of "validation" is the "test method". It appears they have a problem with their test methods.
QuidnuncCBH 1 year ago
If you cannot watch the entire video, I suggest you watch from 0:00 to 3:04 and then 6:45 to 8:06
QuidnuncCBH 1 year ago
Although the below book discusses "Sterile Products", it provides a general overview as well. Of course, the FDA website is quite valuable as well. If you would like an example of searching the FDA databases, please visit my Conversations for a Better World Article:
"A technical perspective on women’s liberation through the Pill"
QuidnuncCBH 1 year ago
As a Chemical Engineer in the pharmaceutical industry, I discovered the following Validation book (1) The committee should know that the laboratory "Test method" is considered the "foundation" of Validation and Validation should be the foundation of "quality" control.
Employee "turnover" is often considered a "red flag" when considering quality. As the below reference book mentions, there is a trend of procrastination.
Validation of Pharmaceutical Process, Sterile Products. F. Carleton
QuidnuncCBH 1 year ago
I hhave contacted Oversight Office to ask them to investigate my Mothers death! She took tylenol es ion October 16. She was admitted to hospital the 17'th. She underwent two major surgeries, her heart stoped, she was in a medicallly induced coma for a week, she had major organ failre, and was on dialysis for over a month, although she was in hospital two months at which time she died on December 12. I am firmly convinced that whatever was in Tylenol was cause of her death.
annroberson1 1 year ago
If all these changes occurred, are there enough people left to fix any problems. What do they know. Are they qualified? With downsizing, are there enough people to continue any "quality" activties?
lifeinnm 1 year ago