Intriguing things that capture our imagination.
During our work, research, and travel, we find a variety of articles, websites, and information that might interest you. Here’s an ever-expanding list that you can sort by topic.
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22 March 2016
21 December 2015
Visualizing data
A fascinating website with lots of information about data visualization from graphs to data maps to “infographics” can be found at flowingdata.com. Check out the books by the site’s owner, Nathan Yau, that are available at Amazon. Warning: you might find yourself spending a lot of time here!
09 December 2015
Error checking
The Wall St Journal (Saturday, 5 Dec 2015, page A2) published an interesting article on how long numbers can include checks to determine if the number is valid or not. The article describes how check digits can confirm a number that is entered. If the check digit isn’t valid, it indicates that an incorrect number was entered.
“Here is a simple example of how they work: A product is identified with a three-digit identification number. The sum of all the digits plus a fourth number—the check digit—must equal a multiple of 10. If the identification number is 123, then the check digit must be 4. “You would attach 4 because 1 + 2 + 3 is 6, and 6 + 4 is 10. When the number is received, if it is not a multiple of 10, you know something happened.” The problem might be a typo, a transmission glitch, or possibly an attempt to fake a valid number.
The system is a bit more complex, however. An algorithm is created to prevent an incorrectly entered sequence like “456” having the same result as the proper sequence of “654”. In this case the position of a number is given a value and each digit is multiplied by that positional value.
Quite clever. It’s a great example of detecting errors before they can cause problems!
09 December 2015
FREE book download: Pharmaceutical and Vaccine Quality Illustrated
A colleague and friend, Dr. Umit Kartoglu who works at WHO headquarters in Geneva, has self-published an excellent reference book on words and terms used in pharma, biopharma, and vaccines. AND it’s a free download as a pdf. You need to get this!
Pharmaceutical and Vaccine Quality Illustrated by Dr. Umit Kartoglu
04 December 2015
Bacteria and Nespresso Coffee Makers: Something new to worry about?
Fascinating article about bacterial contamination that was found in Nespresso coffee makers. A good reason why coffee should not be allowed in drug production areas (or micro labs)! Nature: Scientific Reports – Coffee makers and bacteriome
04 December 2015
Warning Letter citation concerning training
A Sandoz site received a Warning Letter that included a citation on lack of training…
3. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions, and that training in current good manufacturing practice is conducted by qualified individuals (21 CFR 211.25(a)).
During interviews with our investigators, your contract employee who trains other contract employees on good documentation practices was unable to explain the material he was required to present during training. In addition, while a significant number of your contract employees do not speak English, you only provided English training materials to these employees.
We also found an employee’s failing equipment qualification training assessment form in the trash, yet that employee’s official file showed passing results. According to your company policies, personnel with failing scores must be retrained, but your firm was unable to provide evidence of retraining in the employee’s official record.
According to your response of September 22, 2014, department heads are now responsible for training their contractors. Your response is inadequate, as you failed to assess how critical operations were affected by unqualified personnel.
You have not demonstrated that you have provided employees with appropriate resources and training to make sure that they are qualified for the operations they performed. Falsification and manipulation of employee training records is unacceptable.
20 November 2015
Two Einstein quotes…
If you can’t explain it simply, you don’t understand it well enough.
We cannot solve our problems with the same thinking we used when we created them.
14 October 2015
e-Signatures and (dis)honesty
The Wall Street Journal on 14 Oct 2015 reported on a series of seven studies that found that people are more willing to be dishonest when electronically signing a document.
In one study, participants were instructed to perform math problems to obtain raffle tickets. Researchers cross-checked the papers and found that those who used traditional hand-written signatures all reported their results honestly. Of those who signed electronically, 18 percent cheated. The lead researcher concluded that using handwritten signatures deter people from cheating but e-sigs do not.
Link: http://www.wsj.com/articles/the-lies-e-signatures-tell-1444788405?mod=WSJ_TechWSJD_moreTopStories
13 October 2015
Ontario and Canada Financial Support for Training
A recent Toronto Globe and Mail article pointed to several sources for training grants.
The Canada Job Grant (CJG) [http://actionplan.gc.ca/en/initiative/canada-job-grant] is a six-year training grant available across Canada. From 2014 to 2020, businesses can apply for their provincial variant of the program (ie. Canada-Ontario Job Grant [http://www.mentorworks.ca/blog/governmentfunding/ 2015-09-canada-ontario-job-grant-ontario-business-grants-for-training/]) .
“FedDev Ontario [http://www.feddevontario.gc.ca/eic/site/723.nsf/eng/home] has dedicated funding to established Ontario manufacturers looking to carry out in-house or third-party training projects that willlead to improved productivity and export sales performance.”
Link to article: http://www.theglobeandmail.com/report-on-business/small-business/starting-out/how-your-company-can-get-a-training-grant/article26709486/
12 October 2015
Quality Metrics – Comment period extended
FDA has given industry until 27 November 2015 to provide comments on the draft Request for Quality Metrics guideline. Comments can be made using the website: www.regulations.gov and search for the title of the guideline.
21 September 2015
MOOCs and Open Education Around the World
A book about MOOCs – coedited by a friend and mentor, Tom Reeves.
Find the book on Amazon
21 September 2015
Patient Safety – Quality Improvement Module
An interesting website / resource on the topic of human error reduction from the healthcare perspective.
See the module on Duke University Medical Center
21 September 2015
Pfizer completes Hospira takeover
Pfizer completes Hospira takeover and outlines $800m a year cost saving plan.
21 September 2015
Quality Events, Interviews, and Brian Williams
The troubles that Brian Williams had with the changing details of his helicopter experience can be explained, in part, by how we store and re-store our memories.
Download a PDF copy of James Vesper's article, Quality Events, Interviews, and Brian Williams.
21 September 2015
The Coolest Cars at the Planet’s Biggest Motor Show
Need a new car? Save the Porsche Mission for me…
See Wired
21 September 2015
Are College Lectures Unfair?
Research is showing that “active learning” with more structure, feedback, and interaction is a better way of transferring knowledge for many people than lectures.
See NY Times