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Conduct a Gap Analysis of a Validation Programme

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This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a …

This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.

Published in: Health & Medicine

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  • 1. Conduct a Gap Analysis of a Validation Programme g 4 TH A N N U A L V A L I D A T I O N W E E K E U 20-22 MARCH 2013 COPENHAGEN, DENMARK DEBORAH S. TURNER ASSOCIATE DIRECTOR VALIDATION ALKERMES, PLC DEBBIE.TURNER@ALKERMES.COM
  • 2. DisclaimerThe thoughts, ideas, suggestions, recommendations, etc.in hii this presentation are entirely my own. They are not i i l hendorsed by any company, past or present, that I haveworked for or with. As with all of the presentations y p youwill see this week, this one is meant to expose you to newthought processes and new tools to accomplish thosepprocesses. Each company and situation is different and p yrequires thought about the existing environment andconsideration of all factors before implementation. Anyrisk or reward derived from implementing theseprocesses or tools, positive or negative, is entirely yourown.
  • 3. AgendaGetting AcquaintedDefining “GAP Analysis” g yPreparing for a GAP AnalysisDuring the C u g t e CAP Analysis a ys sAfter the GAP AnalysisQuestions
  • 4. Getting Acquainted g q1. COMPANY2. POSITION3. HOW LONG YOU HAVE BEEN IN THE INDUSTRY4. “IF I COULD ONLY GET SOME IDEAS ABOUT HOW TO DEAL WITH ????? PROBLEM, THIS WHOLE CONFERENCE WILL HAVE BEEN WORTH MY TIME.”
  • 5. Defining “GAP Analysis” g y•H O W D O E S I T D I F F E R F R O M A N A U D I T ?•W H Y I S I T B E N E F I C I A L ?
  • 6. Preparing for a GAP Analysis p g y •U N D E R S T A N D I N G T H E S H A R E H O L D E R S A N D THEIR REQUIREMENTS •D E F I N I N G S T A N D A R D S •T O O L S F O R C O N D U C T I N G A G A P A N A L Y S I S
  • 7. During the GAP Analysis g y•C O M M U N I C A T I O N S•D E F I N E E X P E C T A T I O N S•W H A T T O L O O K F O R
  • 8. After the GAP Analysis y•M E T R I C S•F I N A L R E P O R T•I M P L E M E N T I N G I M P R O V E M E N T S A N DREMEDIAL ACTION PLANS
  • 9. QQuestions
  • 10. Conduct a Gap Analysis of a Validation Programme g 4 TH A N N U A L V A L I D A T I O N W E E K E U 20-22 MARCH 2013 COPENHAGEN, DENMARK DEBORAH S. TURNER ASSOCIATE DIRECTOR VALIDATION ALKERMES, PLC DEBBIE.TURNER@ALKERMES.COM