All posts by Pam

Phase 1 Virtual Pharma cGMP

Together with Diane McGuire (PharmAcumen Consulting, Inc), I’ve authored an article to help Phase 1 US-only virtual manufacturers decide how much of a cGMP quality system they need – by examining laws, regulations and guidance. We’d love to get feedback on this topic. Have we missed anything? Gone too far? Leave a comment below, use the comment section at Outsourced Pharma, or drop me a line directly at pasmith@pharmintellectconsulting.com

https://www.outsourcedpharma.com/doc/does-a-phase-virtual-biopharma-company-need-a-cgmp-quality-system-0001

Do the right thing

If you can live by Wharton’s rules, you don’t need a business coach.  Yes, it’s from 1992 and states “Always use pencils, pens and paper which will photocopy.”  That only adds to the charm.

WHARTON’S RULES – SHORT LIST

  1. Do the Right Thing
  2. The Truth Must be Told, But Tact is Allowed.
  3. There is Always a Way.
  4. The World is Not Fair
  5. Keep Your Sense of Humor
  6. It is Better to Ignore Some Things
  7. Conceptual Thinking is Essential, Entertaining and much Easier than Implementation.  Unfortunately, Only Implemented Ideas Pay Off.
  8. Find the Right People and Trust Them, But Check Up Every Once in a While
  9. Use Your Initiative.  Mistakes are Allowed.
  10. Grow Subordinates As Fast As You Can.
  11. Solve Your Own Problems, and Train Subordinates to Solve Theirs.
  12. If the Boss is Making a Mistake, you are Obligated to Tell  Him So, but Not Necessarily in Public.
  13. If Your Boss is No Good, Get A New One.
  14. You Can Spot the Bureaucrat: He’s the One Who Doesn’t Really Care.
  15. It is Nearly Impossible to Save Other People from Themselves.
  16. Go See What is Going On.
  17. Don’t Decide Until You Have To, But Decide Then.
  18. Time is of the Essence in Personnel Matters.
  19. Group Supervisors Don’t Get To Have Morale.
  20. Organization is Not Architecture.  It is Deployment Of Resources.
  21. Rewards and Punishment Must Flow Through the Chain of Command.
  22. Never Lose Your Temper, Except on Purpose.
  23. If a Meeting is Proceeding to the Result you Prefer, or if it is Totally Beyond Redemption, Keep Your Mouth Shut.
  24. Let Your Opponent Underestimate You.
  25. Never Give Your Opponent a Clear Shot.
  26. Leave Your Opponent a Way Out.