The Ethics Of Compliance

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A workshop on converting values to ethics in the industries regulated by the Food and Drug Administration.

Publié dans : Business, Santé & Médecine
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The Ethics Of Compliance

  1. 1. The Ethics of Compliance: Current Good Manufacturing Practices (cGMPs) and the Food and Drug Administration (FDA) [email_address]
  2. 2. Learning Objectives <ul><li>Learn the seven values of cGMP compliance for the 21 st century </li></ul><ul><li>Learn the two keys and four steps to successful cGMP inspections </li></ul><ul><li>Review the five levels of leadership for cGMP compliance </li></ul><ul><li>Learn to mindread the FDA Readiness team </li></ul><ul><li>Learn to mindread the FDA Investigators </li></ul><ul><li>Learn the top 10 things not to do during an FDA Investigation </li></ul><ul><li>Learn the five keys for converting organizational values to cGMP ethics </li></ul>
  3. 3. <ul><li>The “Forrest Gump” Of SlideShare </li></ul><ul><li>Willing To Share His Opinions, And Experience </li></ul><ul><li>Enjoying Watching From the Sidelines </li></ul><ul><li>Gifted at Using Your Watch To Tell You The Time </li></ul>Presenter Disclosure or, Truth In Presenting Mitch Manning is
  4. 4. Ethics Driven Consumer Protection <ul><li>The Seven Values of cGMPs for the 21 st Century </li></ul><ul><li>Communication </li></ul><ul><li>Education </li></ul><ul><li>Harmonization </li></ul><ul><li>Innovation </li></ul><ul><li>Determination </li></ul><ul><li>Reputation </li></ul><ul><li>Documentation </li></ul>
  5. 5. Ethics Driven Consumer Protection <ul><li>The Seven Values of cGMPs for the 21 st Century </li></ul><ul><li>Communication </li></ul><ul><li>Education </li></ul><ul><li>Harmonization </li></ul><ul><li>Innovation </li></ul><ul><li>Determination </li></ul><ul><li>Reputation </li></ul><ul><li>Documentation </li></ul>
  6. 6. Why Concern Ourselves With Values and Ethics? <ul><li>Attitude </li></ul><ul><li>Expectations </li></ul><ul><li>Approach </li></ul><ul><li>Deployment </li></ul><ul><li>Results </li></ul><ul><li>Compliance </li></ul><ul><li>Progress </li></ul><ul><li>Work/Life Balance </li></ul>
  7. 7. Clear, Concise and Correct Quality Values and Ethics <ul><li>Guide people, procedures, and programs </li></ul><ul><li>Provide the context for ethical behavior </li></ul><ul><li>Are the grounding point for cGMP values </li></ul><ul><li>Help clarify and separate right from wrong </li></ul><ul><li>Shelter people in challenging times </li></ul><ul><li>Motivate and inspire people in all situations </li></ul>
  8. 8. Two Keys to CGMP Compliance Attitude – First Priority Aptitude – Second Priority <ul><li>Four Steps to Successful cGMP Inspections </li></ul><ul><li>What </li></ul><ul><li>Why </li></ul><ul><li>How </li></ul><ul><li>Execution </li></ul>
  9. 9. A Borrowed Process Model for Ethical Behavior Added by Mitchell W. Manning, February 2, 2005
  10. 10. Organizing for cGMP Compliance: <ul><li>Four Cultural Elements of cGMP Compliance </li></ul><ul><li>Language </li></ul><ul><li>Technology </li></ul><ul><li>Institutions </li></ul><ul><li>Art </li></ul>
  11. 11. Eight Guiding Principles for Designing Ethics Into cGMP Compliance <ul><li>Quality values must be freely chosen from alternatives.  </li></ul><ul><li>Quality values must be consistent with the purpose of the systems based program, and the sponsoring organization.  </li></ul><ul><li>Quality values must be clear, concise and correct.  </li></ul><ul><li>Quality values must be actionable .  </li></ul>
  12. 12. Eight Guiding Principles for Designing Ethics Into cGMP Compliance <ul><li>Quality values must enhance performance . </li></ul><ul><li>Quality values must be attractive and pride-giving .  </li></ul><ul><li>Quality values must be capable of being communicated .  </li></ul><ul><li>Quality values must be prominently displayed . </li></ul>
  13. 13. Personality, Procedure & Power <ul><li>Five Levels of Leadership for cGMP Compliance </li></ul><ul><li>Gestalt </li></ul><ul><li>Wisdom </li></ul><ul><li>Persuasion </li></ul><ul><li>Seduction </li></ul><ul><li>Force </li></ul>
  14. 14. Who Is On Your Team? <ul><li>Shared Goals and Values </li></ul><ul><li>Sense of Control and Accountability </li></ul>Free Agent Dead Weight Partner Loyalist 2 1 High High
  15. 15. How To Mind Read The FDA Readiness Team: <ul><li>Team Building On Personality Strengths </li></ul><ul><li>Dominance </li></ul><ul><li>Influence </li></ul><ul><li>Conscientiousness </li></ul><ul><li>Steadiness </li></ul>
  16. 16. Appreciate Human Diversity <ul><li>Know the team’s personalities </li></ul>Being criticized for poor quality Quality Loss of personal privacy Thoroughness Conscientiousness Being asked to change Stability Loss of predictability Follow-through Steadiness Being rejected or disliked Approval Loss of approval Enthusiasm Influence Being taken advantage of Control Loss of control Initiative Dominance Fears Goals Stressors Strengths Personality
  17. 17. How To Mind Read The Investigator(s): <ul><li>Five Areas of Predictability </li></ul><ul><li>Purpose of the “Visit” </li></ul><ul><li>Team Composition </li></ul><ul><li>Years of FDA Service </li></ul><ul><li>Walk-Through Behaviors </li></ul><ul><li>Requests </li></ul>
  18. 18. Why cGMP Inspections Fail: <ul><li>The Top Ten Things Not To Do </li></ul><ul><li>Lie </li></ul><ul><li>Cheat </li></ul><ul><li>Steal </li></ul><ul><li>Underestimate </li></ul><ul><li>Over Promise </li></ul><ul><li>Under Deliver </li></ul><ul><li>Procrastinate </li></ul><ul><li>Look Down </li></ul><ul><li>Whine </li></ul><ul><li>Avoid </li></ul>
  19. 19. Converting Organizational Values to cGMP Compliance Ethics: <ul><li>Five Keys </li></ul><ul><li>Illuminate </li></ul><ul><li>Communicate </li></ul><ul><li>Motivate </li></ul><ul><li>Educate </li></ul><ul><li>Administrate </li></ul>
  20. 20. Quality Ideals of America’s Most Admired Companies <ul><li>Innovation </li></ul><ul><li>Employee talent </li></ul><ul><li>Use of corporate assets </li></ul><ul><li>Social responsibility </li></ul><ul><li>Quality of management </li></ul><ul><li>Financial soundness </li></ul><ul><li>Long-term investment value </li></ul><ul><li>Quality of products and services </li></ul>Source: Fortune, magazine
  21. 21. Dominant Global Values <ul><li>Fast </li></ul><ul><li>Cheap </li></ul><ul><li>Perfect </li></ul><ul><li>Personalized </li></ul><ul><li>Unique </li></ul>
  22. 22. When In Rome… <ul><li>The following remain our guiding principles: </li></ul><ul><li>. Risk-based orientation </li></ul><ul><li>. Science-based policies and standards </li></ul><ul><li>. Integrated quality systems orientation </li></ul><ul><li>. International cooperation </li></ul><ul><li>. Strong public health protection </li></ul><ul><li>Source: Final Report – Pharmaceutical cGMPs for the 21 st Century, September 2004. </li></ul><ul><li>Our findings have put the Agency on a path to restructure its oversight of pharmaceutical quality regulation, thereby developing the product quality regulatory system of the future. The following remain our guiding principles: </li></ul><ul><li>Website: http://www.fda.gov/cder/gmp/gmp2004/CGMP%20report%20final04.pdf </li></ul>
  23. 23. cGMP Quality Systems
  24. 24. Opportunities for Designing Ethics Into FDA Regulated Systems Based Programs <ul><li>Enabling Technology Development and Innovation </li></ul><ul><li>Patient and Consumer Protection </li></ul><ul><li>Protecting the Homeland – Counter terrorism </li></ul><ul><li>Using Risk-Based Management Practices </li></ul><ul><li>Empowering Consumers for Better Health </li></ul><ul><li>Improving FDA’s Business Practices </li></ul>Source: Food and Drug Administration Progress and Priorities 2004, September 2004
  25. 25. Back Ground Information <ul><li>www.fda. gov </li></ul><ul><li>http://www.fda.gov/oc/crawford/default. htm </li></ul><ul><li>http://www.fda.gov/oc/initiatives/reports/priorities2004.html </li></ul><ul><li>http://www.fda.gov/oc/crawford/speeches.html </li></ul><ul><li>http://www.fda.gov/opacom/hpview.html </li></ul>
  26. 26. Learning Objectives <ul><li>Learn the seven values of cGMP compliance for the 21 st century </li></ul><ul><li>Learn the two keys and four steps to successful cGMP inspections </li></ul><ul><li>Review the five levels of leadership for cGMP compliance </li></ul><ul><li>Learn to mindread the FDA Readiness team </li></ul><ul><li>Learn to mindread the FDA Investigators </li></ul><ul><li>Learn the top 10 things not to do during an FDA Investigation </li></ul><ul><li>Learn the five keys for converting organizational values to cGMP ethics </li></ul>
  27. 27. Designing Ethics Into cGMP Compliance to be the Frontline for Consumer Protection <ul><li>Conclusion </li></ul><ul><li>Know what you want. </li></ul><ul><li>Know when you have to have it. </li></ul><ul><li>Know what you are willing to pay. </li></ul><ul><li>Parting Advice </li></ul><ul><li>Do the right thing. </li></ul><ul><li>Do your very best. </li></ul><ul><li>Do good for others. </li></ul>
  28. 28. Questions?
  29. 29. You Make The Call <ul><li>National Device Expert on Warning Letters </li></ul><ul><li>National Drug Expert on 483s </li></ul><ul><li>National Drug Expert on Validation </li></ul><ul><li>Recall Coordinator on Recalls </li></ul><ul><li>Investigator on PADE Investigations </li></ul>

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