SlideShare una empresa de Scribd logo

FDA audit series part 5, dealing with the 483 or Warning Letter

•Descargar como PPTX, PDF•
•
Compliance Insight, Inc.
Compliance Insight, Inc.

Dealing with FDA 483 observations or warning letters

EmpresarialesTecnología
1 de 7
Part 5 – What to do with that 483
• You asked for it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 5 – What to do with that 483
When the audit is over, people typically want to go home…relax….take a vacation…anything but deal with the outcome. You have 15 days to respond (those are working days) You now have to get going on the response • Develop your team • Have a format for the response
You need people to work on the response – and management has to be involved in supporting you • People to assess what needs to be changed • People to write the response work • People to gather the data • Management should have a cover letter to the response
You have to resolve the observations systemically Include copies of any changes made – SOPs, batch records, etc. Include training copies as necessary Address how the product is acceptable (hopefully it is) – on the market currently, in operations now and how to control it in the future
As you put the document together, have it reviewed A new set of eyes may have questions that you didn’t see – working closely to a subject will blind you to some obvious issues Serious issues may warrant some legal review All of these things take time – people have to know the “drop dead” date for the response to be finalized. Delivery – return receipt!!! Copies to all pertinent parties
Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!

Recomendados

FDA audit series part 4, the closeout
FDA audit series part 4, the closeoutFDA audit series part 4, the closeout
FDA audit series part 4, the closeoutCompliance Insight, Inc.
 
FDA audit series part 2, what to do when the FDA arrives
FDA audit series part 2, what to do when the FDA arrivesFDA audit series part 2, what to do when the FDA arrives
FDA audit series part 2, what to do when the FDA arrivesCompliance Insight, Inc.
 
FDA audit series part 1, Preparing for the Audit
FDA audit series part 1, Preparing for the AuditFDA audit series part 1, Preparing for the Audit
FDA audit series part 1, Preparing for the AuditCompliance Insight, Inc.
 
Fda audit series part 3, while the fda is there
Fda audit series part 3, while the fda is thereFda audit series part 3, while the fda is there
Fda audit series part 3, while the fda is thereCompliance Insight, Inc.
 
The FDA just called, Now What?
The FDA just called, Now What?The FDA just called, Now What?
The FDA just called, Now What?MasterControl
 
Z 3d 1 - auditor-auditee partnership
Z 3d 1 - auditor-auditee partnershipZ 3d 1 - auditor-auditee partnership
Z 3d 1 - auditor-auditee partnershipRajeswaran Muthu Venkatachalam
 
Non conformity and corrective action
Non conformity and corrective actionNon conformity and corrective action
Non conformity and corrective actionRaghu Malayanuru
 
Being The Auditee
Being The AuditeeBeing The Auditee
Being The Auditeesnroberts0615
 

Recomendados

FDA audit series part 4, the closeout
FDA audit series part 4, the closeoutFDA audit series part 4, the closeout
FDA audit series part 4, the closeoutCompliance Insight, Inc.
 
FDA audit series part 2, what to do when the FDA arrives
FDA audit series part 2, what to do when the FDA arrivesFDA audit series part 2, what to do when the FDA arrives
FDA audit series part 2, what to do when the FDA arrivesCompliance Insight, Inc.
 
FDA audit series part 1, Preparing for the Audit
FDA audit series part 1, Preparing for the AuditFDA audit series part 1, Preparing for the Audit
FDA audit series part 1, Preparing for the AuditCompliance Insight, Inc.
 
Fda audit series part 3, while the fda is there
Fda audit series part 3, while the fda is thereFda audit series part 3, while the fda is there
Fda audit series part 3, while the fda is thereCompliance Insight, Inc.
 
The FDA just called, Now What?
The FDA just called, Now What?The FDA just called, Now What?
The FDA just called, Now What?MasterControl
 
Z 3d 1 - auditor-auditee partnership
Z 3d 1 - auditor-auditee partnershipZ 3d 1 - auditor-auditee partnership
Z 3d 1 - auditor-auditee partnershipRajeswaran Muthu Venkatachalam
 
Non conformity and corrective action
Non conformity and corrective actionNon conformity and corrective action
Non conformity and corrective actionRaghu Malayanuru
 
Being The Auditee
Being The AuditeeBeing The Auditee
Being The Auditeesnroberts0615
 
NON CONFORMANCE REPORTING (1)
NON CONFORMANCE REPORTING (1)NON CONFORMANCE REPORTING (1)
NON CONFORMANCE REPORTING (1)Ahsan Ghori
 
Root Cause Corrective Action
Root Cause Corrective ActionRoot Cause Corrective Action
Root Cause Corrective ActionUbersoldat
 
Corrective & Preventive Action
Corrective & Preventive Action Corrective & Preventive Action
Corrective & Preventive Action Praneet Surti
 
Day in the Life (DILO) of a Proactive Maintenance Manager
Day in the Life (DILO) of a Proactive Maintenance ManagerDay in the Life (DILO) of a Proactive Maintenance Manager
Day in the Life (DILO) of a Proactive Maintenance ManagerRicky Smith CMRP, CMRT
 
Planning and Scheduling Workshop
Planning and Scheduling WorkshopPlanning and Scheduling Workshop
Planning and Scheduling WorkshopProsygma
 
Operating Excellence is built on Corrective & Preventive Actions
Operating Excellence is built on Corrective & Preventive ActionsOperating Excellence is built on Corrective & Preventive Actions
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
 
CAPA (Corrective & Preventive Action) in Pharma Plant
CAPA (Corrective & Preventive Action) in Pharma PlantCAPA (Corrective & Preventive Action) in Pharma Plant
CAPA (Corrective & Preventive Action) in Pharma PlantM. Agung Sumantri
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesBangaluru
 
CAPA Pitfalls and Keys
CAPA Pitfalls and KeysCAPA Pitfalls and Keys
CAPA Pitfalls and KeysGeoff Habiger
 
8 Steps To Success In Maintenance Planning And Scheduling
8 Steps To Success In Maintenance Planning And Scheduling8 Steps To Success In Maintenance Planning And Scheduling
8 Steps To Success In Maintenance Planning And SchedulingRicky Smith CMRP, CMRT
 
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanPresentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanshravan dubey
 
Corrective actions and preventive actions
Corrective actions and preventive actionsCorrective actions and preventive actions
Corrective actions and preventive actionsANKUSH JADHAV
 
Tool Box Talk - Maintenance Planning and Scheduling
Tool Box Talk - Maintenance Planning and SchedulingTool Box Talk - Maintenance Planning and Scheduling
Tool Box Talk - Maintenance Planning and SchedulingRicky Smith CMRP, CMRT
 
Skills of a Proactive Maintenance Technician
Skills of a Proactive Maintenance TechnicianSkills of a Proactive Maintenance Technician
Skills of a Proactive Maintenance TechnicianRicky Smith CMRP, CMRT
 
How to know if your maintenance planning and scheduling is not effective
How to know if your maintenance planning and scheduling is not effectiveHow to know if your maintenance planning and scheduling is not effective
How to know if your maintenance planning and scheduling is not effectiveRicky Smith CMRP, CMRT
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesSushant Sardana
 
Day in the Life of a Proactive Maintenance Technician Article
Day in the Life of a Proactive Maintenance Technician ArticleDay in the Life of a Proactive Maintenance Technician Article
Day in the Life of a Proactive Maintenance Technician ArticleRicky Smith CMRP, CMRT
 
Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009roycohen
 
Ncr writing and_closure
Ncr writing and_closureNcr writing and_closure
Ncr writing and_closureoziel2015
 
New hire orientation good documentation practice presentation
New hire orientation good documentation practice presentationNew hire orientation good documentation practice presentation
New hire orientation good documentation practice presentationJennifer DePaolo
 
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...GMPTraining.com
 
The need for continual training program as a part of cGMP in pharmaceutical i...
The need for continual training program as a part of cGMP in pharmaceutical i...The need for continual training program as a part of cGMP in pharmaceutical i...
The need for continual training program as a part of cGMP in pharmaceutical i...shikha singh
 

Más contenido relacionado

La actualidad más candente

NON CONFORMANCE REPORTING (1)
NON CONFORMANCE REPORTING (1)NON CONFORMANCE REPORTING (1)
NON CONFORMANCE REPORTING (1)Ahsan Ghori
 
Root Cause Corrective Action
Root Cause Corrective ActionRoot Cause Corrective Action
Root Cause Corrective ActionUbersoldat
 
Corrective & Preventive Action
Corrective & Preventive Action Corrective & Preventive Action
Corrective & Preventive Action Praneet Surti
 
Day in the Life (DILO) of a Proactive Maintenance Manager
Day in the Life (DILO) of a Proactive Maintenance ManagerDay in the Life (DILO) of a Proactive Maintenance Manager
Day in the Life (DILO) of a Proactive Maintenance ManagerRicky Smith CMRP, CMRT
 
Planning and Scheduling Workshop
Planning and Scheduling WorkshopPlanning and Scheduling Workshop
Planning and Scheduling WorkshopProsygma
 
Operating Excellence is built on Corrective & Preventive Actions
Operating Excellence is built on Corrective & Preventive ActionsOperating Excellence is built on Corrective & Preventive Actions
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
 
CAPA (Corrective & Preventive Action) in Pharma Plant
CAPA (Corrective & Preventive Action) in Pharma PlantCAPA (Corrective & Preventive Action) in Pharma Plant
CAPA (Corrective & Preventive Action) in Pharma PlantM. Agung Sumantri
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesBangaluru
 
CAPA Pitfalls and Keys
CAPA Pitfalls and KeysCAPA Pitfalls and Keys
CAPA Pitfalls and KeysGeoff Habiger
 
8 Steps To Success In Maintenance Planning And Scheduling
8 Steps To Success In Maintenance Planning And Scheduling8 Steps To Success In Maintenance Planning And Scheduling
8 Steps To Success In Maintenance Planning And SchedulingRicky Smith CMRP, CMRT
 
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanPresentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanshravan dubey
 
Corrective actions and preventive actions
Corrective actions and preventive actionsCorrective actions and preventive actions
Corrective actions and preventive actionsANKUSH JADHAV
 
Tool Box Talk - Maintenance Planning and Scheduling
Tool Box Talk - Maintenance Planning and SchedulingTool Box Talk - Maintenance Planning and Scheduling
Tool Box Talk - Maintenance Planning and SchedulingRicky Smith CMRP, CMRT
 
Skills of a Proactive Maintenance Technician
Skills of a Proactive Maintenance TechnicianSkills of a Proactive Maintenance Technician
Skills of a Proactive Maintenance TechnicianRicky Smith CMRP, CMRT
 
How to know if your maintenance planning and scheduling is not effective
How to know if your maintenance planning and scheduling is not effectiveHow to know if your maintenance planning and scheduling is not effective
How to know if your maintenance planning and scheduling is not effectiveRicky Smith CMRP, CMRT
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesSushant Sardana
 
Day in the Life of a Proactive Maintenance Technician Article
Day in the Life of a Proactive Maintenance Technician ArticleDay in the Life of a Proactive Maintenance Technician Article
Day in the Life of a Proactive Maintenance Technician ArticleRicky Smith CMRP, CMRT
 
Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009roycohen
 
Ncr writing and_closure
Ncr writing and_closureNcr writing and_closure
Ncr writing and_closureoziel2015
 
New hire orientation good documentation practice presentation
New hire orientation good documentation practice presentationNew hire orientation good documentation practice presentation
New hire orientation good documentation practice presentationJennifer DePaolo
 

La actualidad más candente (20)

NON CONFORMANCE REPORTING (1)
NON CONFORMANCE REPORTING (1)NON CONFORMANCE REPORTING (1)
NON CONFORMANCE REPORTING (1)
 
Root Cause Corrective Action
Root Cause Corrective ActionRoot Cause Corrective Action
Root Cause Corrective Action
 
Corrective & Preventive Action
Corrective & Preventive Action Corrective & Preventive Action
Corrective & Preventive Action
 
Day in the Life (DILO) of a Proactive Maintenance Manager
Day in the Life (DILO) of a Proactive Maintenance ManagerDay in the Life (DILO) of a Proactive Maintenance Manager
Day in the Life (DILO) of a Proactive Maintenance Manager
 
Planning and Scheduling Workshop
Planning and Scheduling WorkshopPlanning and Scheduling Workshop
Planning and Scheduling Workshop
 
Operating Excellence is built on Corrective & Preventive Actions
Operating Excellence is built on Corrective & Preventive ActionsOperating Excellence is built on Corrective & Preventive Actions
Operating Excellence is built on Corrective & Preventive Actions
 
CAPA (Corrective & Preventive Action) in Pharma Plant
CAPA (Corrective & Preventive Action) in Pharma PlantCAPA (Corrective & Preventive Action) in Pharma Plant
CAPA (Corrective & Preventive Action) in Pharma Plant
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
CAPA Pitfalls and Keys
CAPA Pitfalls and KeysCAPA Pitfalls and Keys
CAPA Pitfalls and Keys
 
8 Steps To Success In Maintenance Planning And Scheduling
8 Steps To Success In Maintenance Planning And Scheduling8 Steps To Success In Maintenance Planning And Scheduling
8 Steps To Success In Maintenance Planning And Scheduling
 
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanPresentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravan
 
Corrective actions and preventive actions
Corrective actions and preventive actionsCorrective actions and preventive actions
Corrective actions and preventive actions
 
Tool Box Talk - Maintenance Planning and Scheduling
Tool Box Talk - Maintenance Planning and SchedulingTool Box Talk - Maintenance Planning and Scheduling
Tool Box Talk - Maintenance Planning and Scheduling
 
Skills of a Proactive Maintenance Technician
Skills of a Proactive Maintenance TechnicianSkills of a Proactive Maintenance Technician
Skills of a Proactive Maintenance Technician
 
How to know if your maintenance planning and scheduling is not effective
How to know if your maintenance planning and scheduling is not effectiveHow to know if your maintenance planning and scheduling is not effective
How to know if your maintenance planning and scheduling is not effective
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
Day in the Life of a Proactive Maintenance Technician Article
Day in the Life of a Proactive Maintenance Technician ArticleDay in the Life of a Proactive Maintenance Technician Article
Day in the Life of a Proactive Maintenance Technician Article
 
Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009Root Cause And Corrective Action Workshop Cinci Asq 2009
Root Cause And Corrective Action Workshop Cinci Asq 2009
 
Ncr writing and_closure
Ncr writing and_closureNcr writing and_closure
Ncr writing and_closure
 
New hire orientation good documentation practice presentation
New hire orientation good documentation practice presentationNew hire orientation good documentation practice presentation
New hire orientation good documentation practice presentation
 

Destacado

Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...GMPTraining.com
 
The need for continual training program as a part of cGMP in pharmaceutical i...
The need for continual training program as a part of cGMP in pharmaceutical i...The need for continual training program as a part of cGMP in pharmaceutical i...
The need for continual training program as a part of cGMP in pharmaceutical i...shikha singh
 
Good Manufacturing Practices Training by International Food Safety Consultancy
Good Manufacturing Practices Training by International Food Safety ConsultancyGood Manufacturing Practices Training by International Food Safety Consultancy
Good Manufacturing Practices Training by International Food Safety ConsultancyAtlantic Training, LLC.
 
Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing PracticesJorge Torres
 
What is GMP in India?
What is GMP in India?What is GMP in India?
What is GMP in India?InstantGMP™
 

Destacado (10)

Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
Training And Education Within Pharmaceutical Manufacturing Manupharma Summit ...
 
The need for continual training program as a part of cGMP in pharmaceutical i...
The need for continual training program as a part of cGMP in pharmaceutical i...The need for continual training program as a part of cGMP in pharmaceutical i...
The need for continual training program as a part of cGMP in pharmaceutical i...
 
Fda Inspection
Fda InspectionFda Inspection
Fda Inspection
 
21 cfr, parts 210 211
21 cfr, parts 210 21121 cfr, parts 210 211
21 cfr, parts 210 211
 
Good Manufacturing Practices Training by International Food Safety Consultancy
Good Manufacturing Practices Training by International Food Safety ConsultancyGood Manufacturing Practices Training by International Food Safety Consultancy
Good Manufacturing Practices Training by International Food Safety Consultancy
 
GMP Training
GMP TrainingGMP Training
GMP Training
 
Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing Practices
 
FDA Audit - The Do and Don't List
FDA Audit - The Do and Don't ListFDA Audit - The Do and Don't List
FDA Audit - The Do and Don't List
 
What is GMP in India?
What is GMP in India?What is GMP in India?
What is GMP in India?
 
Basics of FDA GMP Training
Basics of FDA GMP TrainingBasics of FDA GMP Training
Basics of FDA GMP Training
 

Similar a FDA audit series part 5, dealing with the 483 or Warning Letter

Case Study: Product Development Redesign for Life Science client
Case Study: Product Development Redesign for Life Science clientCase Study: Product Development Redesign for Life Science client
Case Study: Product Development Redesign for Life Science clientChief Innovation
 
A Study of Innovation by Phil Wheat
A Study of Innovation by Phil WheatA Study of Innovation by Phil Wheat
A Study of Innovation by Phil Wheatiasaglobal
 
Managing yourself: how to be productive with your time
Managing yourself: how to be productive with your timeManaging yourself: how to be productive with your time
Managing yourself: how to be productive with your timeJo Alcock
 
Root Cause Analysis: Think Again! - by Kevin Stewart
Root Cause Analysis: Think Again! - by Kevin StewartRoot Cause Analysis: Think Again! - by Kevin Stewart
Root Cause Analysis: Think Again! - by Kevin StewartASQ Reliability Division
 
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENTREGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENTMichael Swit
 
20-MOD 8 Self and Work Management-20-07-2023.ppt
20-MOD 8 Self and Work Management-20-07-2023.ppt20-MOD 8 Self and Work Management-20-07-2023.ppt
20-MOD 8 Self and Work Management-20-07-2023.pptabhichowdary16
 
Chapter 5 successful problem solving & task mgt
Chapter 5 successful problem solving & task mgtChapter 5 successful problem solving & task mgt
Chapter 5 successful problem solving & task mgtNasz Zainuddin
 
Understanding the Disciplinary Action Process
Understanding the Disciplinary Action ProcessUnderstanding the Disciplinary Action Process
Understanding the Disciplinary Action ProcessG&A Partners
 
Getting in Shape for 2018: Product Management Best Practices
Getting in Shape for 2018: Product Management Best PracticesGetting in Shape for 2018: Product Management Best Practices
Getting in Shape for 2018: Product Management Best PracticesProductPlan
 
Successful EHR Implementation - Strategy & Tips
Successful EHR Implementation - Strategy & TipsSuccessful EHR Implementation - Strategy & Tips
Successful EHR Implementation - Strategy & TipsJames Muir
 
20 Tools of Six Sigma.pptx
20 Tools of Six Sigma.pptx20 Tools of Six Sigma.pptx
20 Tools of Six Sigma.pptxminhajulislam90
 
Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...
Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...
Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...Dakiry
 
EngManagement - Lecture 7.pptx
EngManagement - Lecture 7.pptxEngManagement - Lecture 7.pptx
EngManagement - Lecture 7.pptxshayanzafar2
 
Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...
Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...
Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...Kevin Perry
 

Similar a FDA audit series part 5, dealing with the 483 or Warning Letter (20)

Case Study: Product Development Redesign for Life Science client
Case Study: Product Development Redesign for Life Science clientCase Study: Product Development Redesign for Life Science client
Case Study: Product Development Redesign for Life Science client
 
Project Management for the Curious 2
Project Management for the Curious 2Project Management for the Curious 2
Project Management for the Curious 2
 
A Study of Innovation by Phil Wheat
A Study of Innovation by Phil WheatA Study of Innovation by Phil Wheat
A Study of Innovation by Phil Wheat
 
Managing yourself: how to be productive with your time
Managing yourself: how to be productive with your timeManaging yourself: how to be productive with your time
Managing yourself: how to be productive with your time
 
Root Cause Analysis: Think Again! - by Kevin Stewart
Root Cause Analysis: Think Again! - by Kevin StewartRoot Cause Analysis: Think Again! - by Kevin Stewart
Root Cause Analysis: Think Again! - by Kevin Stewart
 
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENTREGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT
REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT
 
Kaizen
KaizenKaizen
Kaizen
 
Erp implementation
Erp implementationErp implementation
Erp implementation
 
20-MOD 8 Self and Work Management-20-07-2023.ppt
20-MOD 8 Self and Work Management-20-07-2023.ppt20-MOD 8 Self and Work Management-20-07-2023.ppt
20-MOD 8 Self and Work Management-20-07-2023.ppt
 
Chapter 5 successful problem solving & task mgt
Chapter 5 successful problem solving & task mgtChapter 5 successful problem solving & task mgt
Chapter 5 successful problem solving & task mgt
 
Understanding the Disciplinary Action Process
Understanding the Disciplinary Action ProcessUnderstanding the Disciplinary Action Process
Understanding the Disciplinary Action Process
 
Getting in Shape for 2018: Product Management Best Practices
Getting in Shape for 2018: Product Management Best PracticesGetting in Shape for 2018: Product Management Best Practices
Getting in Shape for 2018: Product Management Best Practices
 
Scrum Basics
Scrum BasicsScrum Basics
Scrum Basics
 
Successful EHR Implementation - Strategy & Tips
Successful EHR Implementation - Strategy & TipsSuccessful EHR Implementation - Strategy & Tips
Successful EHR Implementation - Strategy & Tips
 
Getting things done
Getting things doneGetting things done
Getting things done
 
20 Tools of Six Sigma.pptx
20 Tools of Six Sigma.pptx20 Tools of Six Sigma.pptx
20 Tools of Six Sigma.pptx
 
Getting things done
Getting things doneGetting things done
Getting things done
 
Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...
Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...
Романа Косцик “New project begins. Jump in and keep calm. Everything will be ...
 
EngManagement - Lecture 7.pptx
EngManagement - Lecture 7.pptxEngManagement - Lecture 7.pptx
EngManagement - Lecture 7.pptx
 
Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...
Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...
Zablocki, Shawn, Olsson Associates, Top 10 Tips for an Effective Audit, 2015 ...
 

Más de Compliance Insight, Inc.

Más de Compliance Insight, Inc. (8)

July 2015
July 2015July 2015
July 2015
 
GCP Overview by Compliance Insight, Inc.
GCP Overview by Compliance Insight, Inc.GCP Overview by Compliance Insight, Inc.
GCP Overview by Compliance Insight, Inc.
 
About Compliance Insight Inc.
About Compliance Insight Inc.About Compliance Insight Inc.
About Compliance Insight Inc.
 
FDA 483 observations in the lab
FDA 483 observations in the labFDA 483 observations in the lab
FDA 483 observations in the lab
 
FDA GMP Training - The Quality Audit
FDA GMP Training - The Quality AuditFDA GMP Training - The Quality Audit
FDA GMP Training - The Quality Audit
 
Top 22 Tips: Writing For FDA Compliance
Top 22 Tips: Writing For FDA ComplianceTop 22 Tips: Writing For FDA Compliance
Top 22 Tips: Writing For FDA Compliance
 
FDA Warning Letter
FDA Warning LetterFDA Warning Letter
FDA Warning Letter
 
FDA 483
FDA 483FDA 483
FDA 483
 

Último

Organizational Transformation Lead with Culture
Organizational Transformation Lead with CultureOrganizational Transformation Lead with Culture
Organizational Transformation Lead with CultureSeta Wicaksana
 
Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...
Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...
Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...Lviv Startup Club
 
KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...
KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...
KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...Any kyc Account
 
John Halpern sued for sexual assault.pdf
John Halpern sued for sexual assault.pdfJohn Halpern sued for sexual assault.pdf
John Halpern sued for sexual assault.pdfAmzadHosen3
 
VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒
VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒
VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒anilsa9823
 
Monthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptxMonthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptxAndy Lambert
 
Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...
Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...
Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...Dipal Arora
 
Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Neil Kimberley
 
FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756
FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756
FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756dollysharma2066
 
Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...
Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...
Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...amitlee9823
 
Pharma Works Profile of Karan Communications
Pharma Works Profile of Karan CommunicationsPharma Works Profile of Karan Communications
Pharma Works Profile of Karan Communicationskarancommunications
 
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdfRenandantas16
 
The Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case studyThe Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case studyEthan lee
 
Monte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSMMonte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSMRavindra Nath Shukla
 
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
How to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League CityHow to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League CityEric T. Tung
 
A DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMANA DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMANIlamathiKannappan
 

Último (20)

unwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabi
unwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabiunwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabi
unwanted pregnancy Kit [+918133066128] Abortion Pills IN Dubai UAE Abudhabi
 
Organizational Transformation Lead with Culture
Organizational Transformation Lead with CultureOrganizational Transformation Lead with Culture
Organizational Transformation Lead with Culture
 
Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...
Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...
Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...
 
KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...
KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...
KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...
 
Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills
Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pillsMifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills
Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills
 
John Halpern sued for sexual assault.pdf
John Halpern sued for sexual assault.pdfJohn Halpern sued for sexual assault.pdf
John Halpern sued for sexual assault.pdf
 
VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒
VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒
VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒
 
Monthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptxMonthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptx
 
Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...
Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...
Call Girls Navi Mumbai Just Call 9907093804 Top Class Call Girl Service Avail...
 
Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023
 
FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756
FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756
FULL ENJOY Call Girls In Majnu Ka Tilla, Delhi Contact Us 8377877756
 
Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...
Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...
Call Girls Electronic City Just Call 👗 7737669865 👗 Top Class Call Girl Servi...
 
Pharma Works Profile of Karan Communications
Pharma Works Profile of Karan CommunicationsPharma Works Profile of Karan Communications
Pharma Works Profile of Karan Communications
 
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
 
Forklift Operations: Safety through Cartoons
Forklift Operations: Safety through CartoonsForklift Operations: Safety through Cartoons
Forklift Operations: Safety through Cartoons
 
The Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case studyThe Coffee Bean & Tea Leaf(CBTL), Business strategy case study
The Coffee Bean & Tea Leaf(CBTL), Business strategy case study
 
Monte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSMMonte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSM
 
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
 
How to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League CityHow to Get Started in Social Media for Art League City
How to Get Started in Social Media for Art League City
 
A DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMANA DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMAN
 

FDA audit series part 5, dealing with the 483 or Warning Letter

  • 1. Part 5 – What to do with that 483
  • 2. • You asked for it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 5 – What to do with that 483
  • 3. When the audit is over, people typically want to go home…relax….take a vacation…anything but deal with the outcome. You have 15 days to respond (those are working days) You now have to get going on the response • Develop your team • Have a format for the response
  • 4. You need people to work on the response – and management has to be involved in supporting you • People to assess what needs to be changed • People to write the response work • People to gather the data • Management should have a cover letter to the response
  • 5. You have to resolve the observations systemically Include copies of any changes made – SOPs, batch records, etc. Include training copies as necessary Address how the product is acceptable (hopefully it is) – on the market currently, in operations now and how to control it in the future
  • 6. As you put the document together, have it reviewed A new set of eyes may have questions that you didn’t see – working closely to a subject will blind you to some obvious issues Serious issues may warrant some legal review All of these things take time – people have to know the “drop dead” date for the response to be finalized. Delivery – return receipt!!! Copies to all pertinent parties
  • 7. Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!