Conduct a Gap Analysis of a Validation Programmeg

4 T H A N N U A L V A L I D A T I O N W E E K E U2 0 - 2 2 M A R C H 2 0 1 3

C O P E N H A G E N , D E N M A R K,

D E B O R A H S . T U R N E RA S S O C I A T E D I R E C T O R V A L I D A T I O N

A L K E R M E S P L CA L K E R M E S , P L C

D E B B I E . T U R N E R @ A L K E R M E S . C O M

Disclaimer

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

Agenda

Getting Acquainted

Defining “GAP Analysis”g y

Preparing for a GAP Analysis

During the CAP Analysisu g t e C a ys s

After the GAP Analysis

QuestionsQuestions

Getting Acquaintedg q

1 . C O M P A N Y

2 . P O S I T I O N

3 . H O W L O N G Y O U H A V E B E E N I N T H E I N D U S T R YI N D U S T R Y

4 . “ I F I C O U L D O N L Y G E T S O M E I D E A S A B O U T H O W T O D E A L W I T H ? ? ? ? ? P R O B L E M , T H I S W H O L E C O N F E R E N C E W I L L H A V E B E E N W O R T H M Y T I M E . ”

Defining “GAP Analysis”

•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 ?

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 ?

Preparing for a GAP Analysis

•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

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 T H E I R R E Q U I R E M E N T S

•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

During the GAP Analysis

•C O M M U N I C A T I O N S

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

After the GAP Analysis

•M E T R I C S

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 D R E M E D I A L A C T I O N P L A N S

QuestionsQ

Conduct a Gap Analysis of a Validation Programmeg

4 T H A N N U A L V A L I D A T I O N W E E K E U2 0 - 2 2 M A R C H 2 0 1 3

C O P E N H A G E N , D E N M A R K,

D E B O R A H S . T U R N E RA S S O C I A T E D I R E C T O R V A L I D A T I O N

A L K E R M E S P L CA L K E R M E S , P L C

D E B B I E . T U R N E R @ A L K E R M E S . C O M