Monday, February 24, 2020

A Poster: Selling Your Proposal

Have you ever wondered why the Sales and Marketing Departments walk out of the boardroom with a bag full of money after they made their pitch, but board members only see you and your Quality Unit presentation as the bearer of bad news?

I have seen it too many times to count. The Quality Unit has a legitimate business-impacting proposal  that is worthy of serious consideration, but the presentation of their proposal takes the listener into an unfamiliar world and is unable to make the business connection.

Perhaps effective communication is a core competency of the Sales and Marketing Departments, while the Quality Unit relies on the tired arguments of regulatory requirements and the threat of an FDA 483.

Don't get me wrong. Compliance with regulatory requirements is the price of admission into the pharma industry. But that is no reason for putting very little effort into selling  your proposal in a way that is compelling--or swamping the boardroom with a 20-page PowerPoint of endless detail and data.

One underlying principle for making a compelling case to management is to make it simple and direct. In fact, the higher the level of management the simpler and more direct it needs to be.


Here are a few points to consider when developing a proposal:


1.    The general purpose of any proposal is to persuade the readers to do something.

2.    Make the reader understands that the solution is practical and appropriate.

3.    Build the case by demonstration of logic and reason in the approach taken in the solution.

4.    Facts must lead logically and inevitably to the conclusion and/or the solution presented.

5.    Evidence should be given in a descending order of importance, beginning with the most important evidence and ending with the least important.

6.    Any questions the reader might pose should be anticipated and answered in a way that reflects the position of your proposal.

7.    Consider all sides of the argument—providing other alternative solutions to the problem, but showing how the one chosen is superior to the others included.

8.    Answer questions about what you are proposing, how you plan to do it, when you plan to do it, and how much it will cost.

9.    Ascertain the level of knowledge that your audience possesses and take the positions of all your readers into account.

10. Use the materials and language to appeal to the technical level of the reader.  Be concise and direct.


Now--How to structure your proposal.

Consider structuring your proposal using the SPIN method. This method is based on SPIN Selling by Neil Rackham. The SPIN acronym stands for Situation, Problem, Implication and Need. 

Here is a simple poster that illustrates using the SPIN approach. Use it not only to structure your next proposal, but give this your the next staffer that brings you a problem without thinking through how best to address it.

Remember, your added value is your insight to resolving the problem, not just escalating problems to the next level. The same goes for those who report to you.

Hope this helps!




The QA Pharm
John E. Snyder











Saturday, February 15, 2020

Answers to the CGMP Quizzes

Greeting dear followers:

I decided to post the answers to the eleven CGMP quizzes rather than for you to request them. If you are just now starting to study the quizzes, you are on your honor :)

I would still love to hear from you and how your have used these quizzes with your team. Not required, but drop me a note at snyderjohn@mac.com or leave a comment.

Cheers!
The QA Pharm






Sunday, January 5, 2020

Weekly CGMP Quiz 11: Part 211 Subpart K Returned and Salvaged Drug Products. Use with Your Team for Training Credit!

This is the eleventh and final quiz on CGMPs that have appeared weekly here at QA Pharm. I hope you found these quizzes useful in enhancing your CGMP knowledge.

Also, each quiz has had one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all eleven quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

ANSWER KEY: It came to my attention that posting the answer key would allow scrolling ahead for answers before working sequentially through the quizzes.   So....

To obtain the ANSWER KEY. Please send an email to me at snyderjohn@mac.com. Put "ANSWERS" in the subject line. Though not required, I'd love to hear how you used the quizzes with your team or personally.

You will not be put on a mailing list! You will not receive further email from me! I promise. I hate spam too! I'm just trying to be fair in providing the answers.

Click on image below:


Sunday, December 29, 2019

Weekly CGMP Quiz 10: Part 211 Subpart J Records and Reports. Use with Your Team for Training Credit!

This is the tenth of eleven quizzes on CGMPs that will appear about weekly here at QA Pharm. Try it yourself and use as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all eleven quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

Click on image below: