career

Granny and the Seven Deadly Sins Bears

Once there was a Granny who went in search of Seven Deadly Sins jokes.  Of course it was not long before Granny discovered that this was really much fun. What happened was that Granny soon discovered that Seven Bears were less trouble to deal with.

The conclusion Granny reached was that 

You cannot tell the real story without naming names …
So granny asked the first bear: what is your name good sir?

The bear gave Granny a quizical kind of look and replied:
My name is Greed.

G:And what is your story?
G:what do you mean?
G:Everyone has a story.

Greed then asked Granny which story she wanted to hear. Greed was the sort of bear that often made that sort of offer because he realized that many people would only listen to the sort of story they wanted to hear.

Not a story, An opera, said Granny, I wish you help me with my opera. Tell me how I go about building a great opera … One as great as … Hmmmm … The Divine Comedy

Do you realize, responded the Bear, how very Greedy you sound?
You are asking for too much. Why do you ask for something so impossible?

G:Why impossible?
G:Too big, too expensive, too difficult … You on the otherhand are too insignificant. Imagine trusting an unknown Granny with the resources to create something akin to the Divine Comedy!

Well then … Whwt if I start with something … Let’s say along the lines of Tartuffe? Wet my slippers on that first.

You are persistant!

Well, said the Granny, I’ve a lot of time to make up for and only so many years left … Besides who else is doing anything to provide jobs. Think of all the more jobs we could provide with some project like the Divine Comedy. We might even hire John Lennon … George Harrison … Johnny Cash … Chet Atkins …

But aren’t they all gone … Somewhere … How could you include them?

There is my point … Anything is possible if you dream big. And since they don’t need the money … We’ll donate it to my favourite cause … ME!

Granny … You are just plain greedy

Advertisement

Drugs RSVP

I checked my RSVP list George … You know the one that tells me what Topics I need to avoid in order not to be cosidered a social deviant … 

RSVP? … You know George … Religion, Sex, Politics …
V? Not sure about that one.

Anyway what I discovered is that nowhere do I find drugs on the RSVP list.
Drugs George … we can talk about drugs.
That’s what keeps the world together. 
How do I know? 
Well I suppose I must confess to my ignorance George.  It is really not something I know for sure.

I do not really know very much of anything for sure.  What I do is just poke around and eventually find a bit of information here and a bit of information there … Oh and from what I hear on the news … And why would I not believe what I hear?

So for the drugs I went to Duke University.
Nary a sign of drugs there.

Found a drug-related something called environmental monitoring in Toronto

And auditing … Even something here called Pharmaceutical Auditing … And what you can learn if you want to take a course 
Quote:”
regulatory requirements and quality standards as well as the ability to carry out in-depth audits of quality systems in the pharmaceutical industry.
…
four main components of the quality system: management controls, design controls, production and process controls, and corrective and preventive actions …”
And
“… how to plan, execute, report and close-down complicated and advance pharmaceutical, biopharmaceutical and supplier audits.”

Why would someone want to close-down an audit George … Am I wrong in thinking that an audit is something that keeps the world operating the way the world is supposed to operate?

Yes I am aware that a company usually gets a warning before auditors come in … That way they can clean up their act and keep everybody happy and nobody is the wiser … Isn’t that the way it works George?

But you know what … There really is a lot more to drugs than I ever realized … Something called “Pharmaceutical Regulatory Affairs”
Hmmmmm … What do you think George?

Something along the lines of 
“rules and regulations affecting pharmaceutical, biological, natural health products and medical devices.”

Some real important sounding stuff too
“international food and drug laws, regulations and guidelines … regulatory submissions and requirements … intellectual properties … pharmaceutical drug development 
…

Non-clinical studies … regulatory filings … human clinical trials …

Hnnnn wonder what this is: “global submission in the CTD format”

Ah hhhh here it is George
“marketing applications for drugs and biologics, known as the Common Technical Document (CTD) … finalized by the International Conference on Harmonization (ICH) in 2003.  Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe.”

Wonder what that ICH means … No George not itch … Nothing to do with being itchy … Well … Unless you have an allergy I suppose …
Then again I suppose there are companies that might be itching to get a new product out as soon as possible … You know what they say George “time is money”
No George I don’t think it has anything to do with running a business from prison. … Then again …

hmmmm good place to go to get letters after your name … Sounds real professional … Well like in all these new careers
CMW – certified medical writing
DM – document management

Wuuuuuu
Check this mouthful George
GRAC – global regulatory affairs compliance

Yep … Sure are one pile of new careers George … At least they might be careers …

FDA, CBER, IND, NDA, BLA, ANDA, ABLA …. No George … No idea what they mean … Sure sounds important though … Guess you need to be an insider to understand the arcane language.

Guess that’s enough drugs for today.