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Quality audits

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Vasanth Kumar
Vasanth Kumar
Gesundheit & MedizinBusinessTechnologie
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The Quality Auditing [Training for Quality Auditors]
Course Syllabus and Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],What is an Audit?
[object Object],What is an Audit? Continued…
[object Object],[object Object],What is an Audit? Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Types of Audits
[object Object],[object Object],[object Object],[object Object],[object Object],Internal Audit
[object Object],[object Object],[object Object],[object Object],Internal Audit Continued…
AUDITOR Conduct and Necessary Skills
[object Object],[object Object],[object Object],A Good Auditor should have..
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Traits of a Good GMP Auditor
[object Object],[object Object]
Undesirable Traits of a GMP Auditor ,[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],Auditors Behavior
[object Object],[object Object],[object Object],[object Object],[object Object],Auditors Behavior Continued…
[object Object],[object Object],[object Object],[object Object],Auditors Responsibilities
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Difficult situations may arise
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Communications
Communications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
QUALITY AUDIT Preparation and Planning
[object Object],[object Object],[object Object],[object Object],[object Object],Planning and Preparation
[object Object],[object Object],[object Object],[object Object],[object Object],Audit Planning
[object Object],[object Object],[object Object],[object Object],[object Object],Audit Planning Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Audit Planning Continued…
[object Object],[object Object],[object Object],[object Object],Communicate the Audit Plan
[object Object],[object Object],[object Object],[object Object],Selection of Auditors
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Preparing for Audit
[object Object],[object Object],[object Object],[object Object],[object Object],Pre-audit Information
Need Break?
Performing the Quality Audit
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Performing The Quality Audit
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The Opening Meeting
The Site / Area Tour ,[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],The Site / Area Tour Continued…
The Site / Area Tour Continued… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Beginning the “Conference Room” Audit ,[object Object],[object Object],[object Object],[object Object],[object Object]
Conference Room Audit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],Auditing Techniques
[object Object],[object Object],[object Object],Auditing Techniques Continued… ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],Auditing Techniques Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Auditing Techniques Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Auditing Techniques Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Questioning Techniques
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Questioning Techniques Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Questioning Techniques Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Questioning Techniques Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The Daily Wrap-up (For multiple day audits)
[object Object],[object Object],[object Object],[object Object],Classification of Audit Observations
[object Object],[object Object],[object Object],[object Object],[object Object],Classification of Audit Observations Continued…
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The Close-Out Meeting
Audit Report and Follow-up
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Reporting Audits
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],After the Audit
Remember!! Performing the audit is the easiest part of the audit process. Successfully completing a timely and thorough audit observation follow-up is the most difficult and time consuming facet of the audit. Ensure through your persistence, tenacity, a sense of efficient organization, that you follow each observation through to its final, cGMP compliant conclusion. Never give up!
THANK YOU

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Quality audits

  • 1. The Quality Auditing [Training for Quality Auditors]
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  • 10. AUDITOR Conduct and Necessary Skills
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  • 52. Audit Report and Follow-up
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  • 55. Remember!! Performing the audit is the easiest part of the audit process. Successfully completing a timely and thorough audit observation follow-up is the most difficult and time consuming facet of the audit. Ensure through your persistence, tenacity, a sense of efficient organization, that you follow each observation through to its final, cGMP compliant conclusion. Never give up!