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The Ethics Of Compliance

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Mitchell Manning Sr.
Mitchell Manning Sr.

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

BusinessGesundheit & Medizin
1 von 29
The Ethics of Compliance: Current Good Manufacturing Practices (cGMPs) and the Food and Drug Administration (FDA) [email_address]
Learning Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],Presenter Disclosure or, Truth In Presenting Mitch Manning is
Ethics Driven Consumer Protection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ethics Driven Consumer Protection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why Concern Ourselves With Values and Ethics? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clear, Concise and Correct Quality Values and Ethics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Two Keys to CGMP Compliance Attitude – First Priority Aptitude – Second Priority ,[object Object],[object Object],[object Object],[object Object],[object Object]
A Borrowed Process Model for Ethical Behavior Added by Mitchell W. Manning, February 2, 2005
Organizing for cGMP Compliance: ,[object Object],[object Object],[object Object],[object Object],[object Object]
Eight Guiding Principles for Designing Ethics Into cGMP Compliance ,[object Object],[object Object],[object Object],[object Object]
Eight Guiding Principles for Designing Ethics Into cGMP Compliance ,[object Object],[object Object],[object Object],[object Object]
Personality, Procedure & Power ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Who Is On Your Team? ,[object Object],[object Object],Free Agent Dead Weight Partner Loyalist 2 1 High High
How To Mind Read The FDA Readiness Team: ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appreciate Human Diversity ,[object Object],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
How To Mind Read The Investigator(s): ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why cGMP Inspections Fail: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Converting Organizational Values to cGMP Compliance Ethics: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Quality Ideals of America’s Most Admired Companies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source: Fortune, magazine
Dominant Global Values ,[object Object],[object Object],[object Object],[object Object],[object Object]
When In Rome… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
cGMP Quality Systems
Opportunities for Designing Ethics Into FDA Regulated Systems Based Programs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source: Food and Drug Administration Progress and Priorities 2004, September 2004
Back Ground Information ,[object Object],[object Object],[object Object],[object Object],[object Object]
Learning Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Designing Ethics Into cGMP Compliance to be the Frontline for Consumer Protection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Questions?
You Make The Call ,[object Object],[object Object],[object Object],[object Object],[object Object]

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The Ethics Of Compliance

  • 1. The Ethics of Compliance: Current Good Manufacturing Practices (cGMPs) and the Food and Drug Administration (FDA) [email_address]
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  • 9. A Borrowed Process Model for Ethical Behavior Added by Mitchell W. Manning, February 2, 2005
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Hinweis der Redaktion

  1. FDA will also conduct its own evaluation studies. The Agency will explore and identify relationships between FDA actions and accomplishments under the CGMP Initiative, and subsequent improvements in public health. Examples of such actions and accomplishments are: the adoption of quality systems by industry; the use of risk factors to select inspection sites; and the review of the warning letter process. The studies will attempt to link such activities to their impact on regulated industry and on public health-related outcomes (e.g., improvement in drug quality). FDA also plans to validate the CGMP Initiative’s contributions to the Agency’s longterm goals and mission.