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Leadership For The FDA Inspection The Manager Review

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Mitchell Manning Sr.
Mitchell Manning Sr.

The document outlines an agenda for a leadership review presentation on preparing for and managing an FDA inspection. The agenda includes introductions to FDA inspections, critical cGMP elements, job performance scenarios and role plays, and a review section. Key points covered are the types of FDA inspections, how deficiencies are cited, leadership roles and responsibilities during inspections, readiness checks, and responding to 483 observations.

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Our Leadership for an FDA Inspection: The Managers’ Review Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators.
Agenda 1. Introduction to the FDA Inspection 2. Our Leadership of the FDA Inspection 3. Experiences from Inspections 4. Critical cGMP elements 5. Job performance - scenarios and role plays 6. Review/Wrap-Up/Questions
1. Introduction to the FDA Inspection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Introduction to the FDA Inspection A. Types of Inspections ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Introduction to the FDA Inspection C. How we get into trouble ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Introduction to the FDA Inspection D. The need for a successful inspection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Introduction to the FDA Inspection D. The need for a successful inspection cont’d ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Introduction to the FDA Inspection E. FDA Actions – if we don’t have a successful inspection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Introduction to the FDA Inspection F. The FDA’s Inspection Team ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection ,[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection E. Readiness Plan ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2. Our Leadership for the FDA Inspection F. Readiness Check contd
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],2. Our Leadership for the FDA Inspection G. Follow Up to Readiness Checks
2. Our Leadership for the FDA Inspection H. Where will the FDA look? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection I. Current Status and Next Steps ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection I. Current Status and Next Steps cont’d ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Our Leadership for the FDA Inspection J. Our Assessment Process ,[object Object],[object Object],[object Object],[object Object],[object Object]
3. Experiences from other inspections. ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
3. Experiences A. Do’s (continued) ,[object Object],[object Object],[object Object],[object Object],[object Object]
3. Experiences B. Don’ts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
3. Experiences B. Don’ts (continued) ,[object Object],[object Object],[object Object],[object Object]
3. Experiences C. Possible scenario ,[object Object],[object Object]
3. Experience C. Possible Scenarios ,[object Object],[object Object],[object Object],[object Object]
3. Experiences C. Possible scenarios ,[object Object],[object Object],[object Object],[object Object],[object Object]
3. Experiences C. Possible scenario ,[object Object],[object Object],[object Object],[object Object]
3. Experience C. Possible scenario ,[object Object],[object Object],[object Object]
3. Experience C. Possible scenario ,[object Object],[object Object],[object Object]
4. Critical cGMP Elements ,[object Object],[object Object],[object Object],[object Object],[object Object]
4. Critical cGMP elements cont’d ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5. Job Performance – Scenarios and Role Plays ,[object Object],[object Object]
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
5. Job Performance – Role Plays and Scenarios ,[object Object],[object Object],[object Object]
A. Discarding original data ,[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
B. OOS Investigations ,[object Object],[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
B. OOS Investigations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
C. First impressions ,[object Object],[object Object],[object Object],5. Job Performance – Scenarios and Role Plays
First Impressions are Lasting Impressions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
6. Review/Wrap-Up/Questions ,[object Object],[object Object],[object Object]
6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
[object Object],[object Object],[object Object],[object Object],6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],6. Review/Wrap-Up/Questions A. Responses to FDA-483 Observations
6. Review/Wrap-Up/Questions B. Managers Can. . . ,[object Object],[object Object],[object Object],[object Object]
6. Review/Wrap-Up/Questions C. FDA Reference Sources ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
I’m so glad the inspection is over. The FDA is gone. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Leadership For The FDA Inspection The Manager Review

  • 1. Our Leadership for an FDA Inspection: The Managers’ Review Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators.
  • 2. Agenda 1. Introduction to the FDA Inspection 2. Our Leadership of the FDA Inspection 3. Experiences from Inspections 4. Critical cGMP elements 5. Job performance - scenarios and role plays 6. Review/Wrap-Up/Questions
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