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.

1. Conduct a Gap Analysis of a
Validation Programme
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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. Disclaimer
The thoughts, ideas, suggestions, recommendations, etc.
in hi
i this presentation are entirely my own. They are not
i i l h
endorsed by any company, past or present, that I have
worked for or with. As with all of the presentations y
p you
will see this week, this one is meant to expose you to new
thought processes and new tools to accomplish those
p
processes. Each company and situation is different and
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requires thought about the existing environment and
consideration of all factors before implementation. Any
risk or reward derived from implementing these
processes or tools, positive or negative, is entirely your
own.

3. Agenda
Getting Acquainted
Defining “GAP Analysis”
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Preparing for a GAP Analysis
During the C
u g t e CAP Analysis
a ys s
After the GAP Analysis
Questions

4. Getting Acquainted
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1. COMPANY
2. POSITION
3. HOW LONG YOU HAVE BEEN IN THE
INDUSTRY
4. “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”
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•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
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•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
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•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
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•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 D
REMEDIAL ACTION PLANS

9. Q
Questions

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