The Ethics of Compliance: Current Good Manufacturing Practices (cGMPs) and the Food and Drug Administration (FDA) [email_address]

Learning Objectives Learn the seven values of cGMP compliance for the 21 st century Learn the two keys and four steps to successful cGMP inspections Review the five levels of leadership for cGMP compliance Learn to mindread the FDA Readiness team Learn to mindread the FDA Investigators Learn the top 10 things not to do during an FDA Investigation Learn the five keys for converting organizational values to cGMP ethics

Learn the seven values of cGMP compliance for the 21 st century

Learn the two keys and four steps to successful cGMP inspections

Review the five levels of leadership for cGMP compliance

Learn to mindread the FDA Readiness team

Learn to mindread the FDA Investigators

Learn the top 10 things not to do during an FDA Investigation

Learn the five keys for converting organizational values to cGMP ethics

The “Forrest Gump” Of SlideShare Willing To Share His Opinions, And Experience Enjoying Watching From the Sidelines Gifted at Using Your Watch To Tell You The Time Presenter Disclosure or, Truth In Presenting Mitch Manning is

The “Forrest Gump” Of SlideShare

Willing To Share His Opinions, And Experience

Enjoying Watching From the Sidelines

Gifted at Using Your Watch To Tell You The Time

Ethics Driven Consumer Protection The Seven Values of cGMPs for the 21 st Century Communication Education Harmonization Innovation Determination Reputation Documentation

The Seven Values of cGMPs for the 21 st Century

Communication

Education

Harmonization

Innovation

Determination

Reputation

Documentation

Ethics Driven Consumer Protection The Seven Values of cGMPs for the 21 st Century Communication Education Harmonization Innovation Determination Reputation Documentation

The Seven Values of cGMPs for the 21 st Century

Communication

Education

Harmonization

Innovation

Determination

Reputation

Documentation

Why Concern Ourselves With Values and Ethics? Attitude Expectations Approach Deployment Results Compliance Progress Work/Life Balance

Attitude

Expectations

Approach

Deployment

Results

Compliance

Progress

Work/Life Balance

Clear, Concise and Correct Quality Values and Ethics Guide people, procedures, and programs Provide the context for ethical behavior Are the grounding point for cGMP values Help clarify and separate right from wrong Shelter people in challenging times Motivate and inspire people in all situations

Guide people, procedures, and programs

Provide the context for ethical behavior

Are the grounding point for cGMP values

Help clarify and separate right from wrong

Shelter people in challenging times

Motivate and inspire people in all situations

Two Keys to CGMP Compliance Attitude – First Priority Aptitude – Second Priority Four Steps to Successful cGMP Inspections What Why How Execution

Four Steps to Successful cGMP Inspections

What

Why

How

Execution

A Borrowed Process Model for Ethical Behavior Added by Mitchell W. Manning, February 2, 2005

Organizing for cGMP Compliance: Four Cultural Elements of cGMP Compliance Language Technology Institutions Art

Four Cultural Elements of cGMP Compliance

Language

Technology

Institutions

Art

Eight Guiding Principles for Designing Ethics Into cGMP Compliance Quality values must be freely chosen from alternatives. Quality values must be consistent with the purpose of the systems based program, and the sponsoring organization. Quality values must be clear, concise and correct. Quality values must be actionable .

Quality values must be freely chosen from alternatives.

Quality values must be consistent with the purpose of the systems based program, and the sponsoring organization.

Quality values must be clear, concise and correct.

Quality values must be actionable .

Eight Guiding Principles for Designing Ethics Into cGMP Compliance Quality values must enhance performance . Quality values must be attractive and pride-giving . Quality values must be capable of being communicated . Quality values must be prominently displayed .

Quality values must enhance performance .

Quality values must be attractive and pride-giving .

Quality values must be capable of being communicated .

Quality values must be prominently displayed .

Personality, Procedure & Power Five Levels of Leadership for cGMP Compliance Gestalt Wisdom Persuasion Seduction Force

Five Levels of Leadership for cGMP Compliance

Gestalt

Wisdom

Persuasion

Seduction

Force

Who Is On Your Team? Shared Goals and Values Sense of Control and Accountability Free Agent Dead Weight Partner Loyalist 2 1 High High

Shared Goals and Values

Sense of Control and Accountability

How To Mind Read The FDA Readiness Team: Team Building On Personality Strengths Dominance Influence Conscientiousness Steadiness

Team Building On Personality Strengths

Dominance

Influence

Conscientiousness

Steadiness

Appreciate Human Diversity Know the team’s personalities 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

Know the team’s personalities

How To Mind Read The Investigator(s): Five Areas of Predictability Purpose of the “Visit” Team Composition Years of FDA Service Walk-Through Behaviors Requests

Five Areas of Predictability

Purpose of the “Visit”

Team Composition

Years of FDA Service

Walk-Through Behaviors

Requests

Why cGMP Inspections Fail: The Top Ten Things Not To Do Lie Cheat Steal Underestimate Over Promise Under Deliver Procrastinate Look Down Whine Avoid

The Top Ten Things Not To Do

Lie

Cheat

Steal

Underestimate

Over Promise

Under Deliver

Procrastinate

Look Down

Whine

Avoid

Converting Organizational Values to cGMP Compliance Ethics: Five Keys Illuminate Communicate Motivate Educate Administrate

Five Keys

Illuminate

Communicate

Motivate

Educate

Administrate

Quality Ideals of America’s Most Admired Companies Innovation Employee talent Use of corporate assets Social responsibility Quality of management Financial soundness Long-term investment value Quality of products and services Source: Fortune, magazine

Innovation

Employee talent

Use of corporate assets

Social responsibility

Quality of management

Financial soundness

Long-term investment value

Quality of products and services

Dominant Global Values Fast Cheap Perfect Personalized Unique

Fast

Cheap

Perfect

Personalized

Unique

When In Rome… The following remain our guiding principles: . Risk-based orientation . Science-based policies and standards . Integrated quality systems orientation . International cooperation . Strong public health protection Source: Final Report – Pharmaceutical cGMPs for the 21 st Century, September 2004. 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: Website: http://www.fda.gov/cder/gmp/gmp2004/CGMP%20report%20final04.pdf

The following remain our guiding principles:

. Risk-based orientation

. Science-based policies and standards

. Integrated quality systems orientation

. International cooperation

. Strong public health protection

Source: Final Report – Pharmaceutical cGMPs for the 21 st Century, September 2004.

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:

Website: http://www.fda.gov/cder/gmp/gmp2004/CGMP%20report%20final04.pdf

cGMP Quality Systems

Opportunities for Designing Ethics Into FDA Regulated Systems Based Programs Enabling Technology Development and Innovation Patient and Consumer Protection Protecting the Homeland – Counter terrorism Using Risk-Based Management Practices Empowering Consumers for Better Health Improving FDA’s Business Practices Source: Food and Drug Administration Progress and Priorities 2004, September 2004

Enabling Technology Development and Innovation

Patient and Consumer Protection

Protecting the Homeland – Counter terrorism

Using Risk-Based Management Practices

Empowering Consumers for Better Health

Improving FDA’s Business Practices

Back Ground Information www.fda. gov http://www.fda.gov/oc/crawford/default. htm http://www.fda.gov/oc/initiatives/reports/priorities2004.html http://www.fda.gov/oc/crawford/speeches.html http://www.fda.gov/opacom/hpview.html

www.fda. gov

http://www.fda.gov/oc/crawford/default. htm

http://www.fda.gov/oc/initiatives/reports/priorities2004.html

http://www.fda.gov/oc/crawford/speeches.html

http://www.fda.gov/opacom/hpview.html

Learning Objectives Learn the seven values of cGMP compliance for the 21 st century Learn the two keys and four steps to successful cGMP inspections Review the five levels of leadership for cGMP compliance Learn to mindread the FDA Readiness team Learn to mindread the FDA Investigators Learn the top 10 things not to do during an FDA Investigation Learn the five keys for converting organizational values to cGMP ethics

Learn the seven values of cGMP compliance for the 21 st century

Learn the two keys and four steps to successful cGMP inspections

Review the five levels of leadership for cGMP compliance

Learn to mindread the FDA Readiness team

Learn to mindread the FDA Investigators

Learn the top 10 things not to do during an FDA Investigation

Learn the five keys for converting organizational values to cGMP ethics

Designing Ethics Into cGMP Compliance to be the Frontline for Consumer Protection Conclusion Know what you want. Know when you have to have it. Know what you are willing to pay. Parting Advice Do the right thing. Do your very best. Do good for others.

Conclusion

Know what you want.

Know when you have to have it.

Know what you are willing to pay.

Parting Advice

Do the right thing.

Do your very best.

Do good for others.

Questions?

You Make The Call National Device Expert on Warning Letters National Drug Expert on 483s National Drug Expert on Validation Recall Coordinator on Recalls Investigator on PADE Investigations

National Device Expert on Warning Letters

National Drug Expert on 483s

National Drug Expert on Validation

Recall Coordinator on Recalls

Investigator on PADE Investigations