You’ll learn about the CAPA process and how this process helps you to better plan for the future. This slide discusses the definition of Corrective Action Preventive Action (CAPA), how to use CAPA to better plan for the future, a practical understanding of each step of CAPA, and the benefits of CAPA after COVID-19 pandemic. Learn more about how Seuss+ can help you at our website www.seuss.plus

1. Preventing problems and
mitigating risks using CAPA
Webinar
• Hellen Boering
• Director of Operations, Seuss+

2. Helping Biotech
companies strengthen
their assets, to prepare
for commercialization
or sale.

3. Life Science Consulting
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selection, vendor management,
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negotiations, compliance, risk, marketing,
and strategy.
Organizational Development
Growth and
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and organizational consultants navigate
you through the complex evolution of your
life science organization.

4. Introduction
CAPA has its origin in the
GMP environment.
The GCP environment is
moving from detecting
and fixing issues to
prevention.
CAPA is a strong tool to
enable continuously
improvements of the
Quality Management
System.
CAPA is mostly used for
audit and inspection
finding follow-up.
CAPA is looking back to
move forward.
Not all issues/ problem
require full CAPA process.

5. Risk
What is CAPA all about
Resolve problem Improve
Zoom out Zoom in
problem
Impact
Investigation
Root
cause
Corrective
action
Correction Preventive
action

6. Risk
What is CAPA all about
Resolve problem Improve
Zoom out Zoom in
problem
Impact
Investigation
Root
cause
Corrective
action
Correction Preventive
action

7. CAPA explained

8. An example: A lot of litter
Ice cream spoons and ice- and chips trays on the Sloterweg
The story in summary
 Visitors of the ice cream and fries
shops cause a lot of litter.
 The shop owners hate this.
 9-year-old was annoyed and started
cleaning by herself.
 Looking for sustainable packaging
 Need for garbage bins on parking lot
 Replace open garbage bins for
closed as birds create mess picking
from open garbage bins
 Regular clean up by kids and
workgroup ‘clean Sloten’.
 Readers, please address people if
you see them throwing garbage on
the ground.

9. Problem, Impact and Risk

10. Problem
Observation
A lot of litter
Impact
How big is the problem (scale)
Risk
What is the risk (possible damage)
Square with fries and ice cream shop
Parking behind the mill
Pollution of environment
Authorities will keep shops
responsible and close the shops
Protest neighbourhood

11. Investigation and Root cause

12. Problem
Observation
Spoons & trays
A lot of litter
Impact
How big is the problem (scale)
Root cause
Base for improvement
Risk
What is the risk (possible damage)
Investigation
Open mind!
Square with fries and ice cream shop
Parking behind the mill
Birds through litter out garbage bins
People through their litter on the ground
Pollution of environment
No garbage bin on parking
Open garbage bins on square
Bad behaviour of people
Authorities will keep shops
responsible and close the shops
Protest neighbourhood

13. Corrections, Corrective Actions and Preventive actions

14. Correction
Eliminate the problem
A 9yr old girl starts cleaning the square
Corrective action
Eliminate the root cause
Preventive action
Mitigate the risk
Others will help cleaning the square
Use sustainable packages
Place bins on parking lot
Replace open bins by closed bins
Address behaviour visitors
Check and replace bins in other
areas around ice and fries shops
Campaign on behaviour

15. Implementation Plan and Effectivity check

16. Correction
Eliminate the problem
A 9yr old girl starts cleaning the square
Corrective action
Eliminate the route cause
Effectivity check
Confirm the right root cause and action
Preventive action
Mitigate the risk
Implementation
Budget, resources, timelines
Others will help cleaning the square
Use sustainable packages
Place bins on parking lot
Replace open bins by closed bins
Address behaviour visitors
Check and replace bins in other
areas around ice and fries shops
Check after 1 month to see if actions 1&2
has been taken and if the situation
improved
1.
3. Shop owners introduce
sustainable package
2. Shop owners inform clients
Check after 6m package replaced
Campaign on behaviour
Effect of the campaign

17. COVID-19 and clinical trials

18. Problem, Impact and Risk

19. Problem
Observation
Impact
How big is the problem (scale)
Risk
What is the risk (possible damage)
Some sites unaffected, some sites
complete stop, some sites in the middle
Effect of COVID-19 on clinical trials
Global
Add possible risks of
the effect of COVID-
19 on clinical trials to
the chat

20. Problem
Observation
Impact
How big is the problem (scale)
Risk
What is the risk (possible damage)
Lack of site staff
Some sites unaffected, some sites
complete stop, some sites in the middle
Effect of COVID-19 on clinical trials
Global
Delays in IP shipments
Risk for participants – study specific
Financial risk for investigator sites

21. Investigation and Root cause

22. Problem
Observation
Impact
How big is the problem (scale)
Root cause
Base for improvement
Risk
What is the risk (possible damage)
Investigation
Open mind!
Lack of site staff
Remote monitoring underutilization
Some sites unaffected, some sites
complete stop, some sites in the middle
Effect of COVID-19 on clinical trials
Global
Not all protocol assessments were
performed.
Conduct trial, country, site assessment
Delays in IP shipments
Risk for participants – study specific
Financial risk for investigator sites
Add possible root
causes for
underutilization in
the chat

23. Problem
Observation
Impact
How big is the problem (scale)
Root cause
Base for improvement
Risk
What is the risk (possible damage)
Investigation
Open mind!
Lack of site staff
Remote monitoring underutilized
Conservative approach towards
innovations in industry.
Some sites unaffected, some sites
complete stop, some sites in the middle
Effect of COVID-19 on clinical trials
Global
Not all protocol assessments were
performed.
Too many assessments per protocol.
Conduct trial, country, site assessment
Delays in IP shipments
Risk for participants – study specific
Financial risk for investigator sites

24. Corrections, Corrective Actions and Preventive actions
Add any action you have seen (correction,
corrective action and preventive action) in the chat

25. Correction
Eliminate the problem
Corrective action
Eliminate the route cause
Preventive action
Mitigate the risk
FDA/EMA guidance during COVID-19
should become the standard.
Switch to remote monitoring
Dress down protocols to must haves
Optimize remote source data access
Virtual monitoring visits
Remote patient visits Minimize in-person visits Maximize remote assessments
Authority guidance
Upfront payments to sites

26. Implementation Plan and Effectivity check

27. Correction
Eliminate the problem
Corrective action
Eliminate the route cause
Effectivity check
Confirm the right root cause and action
Preventive action
Mitigate the risk
Implement actions
Budget, resources, timelines
FDA/EMA guidance during COVID-19
should become the standard.
Switch to remote monitoring
Investments to investigate further
Dress down protocols to must haves
e.g. 1 July 2021 increase in remote
monitoring, decrease in ‘nice to haves’ in
the protocol.
Optimize remote source data access
Virtual monitoring visits
Remote patient visits Minimize in-person visits Maximize remote assessments
Authority guidance
Upfront payments to sites

28. Looking back to move forward.

29. Risk
Jumping into action is good. Looking back and learn from it is
better.
Resolve problem Improve
Zoom out Zoom in
problem
Impact
Investigation
Root
cause
Corrective
action
Correction Preventive
action

30. What have we learned
• CAPA can and should be used more often to prevent problem from happening (again) and
to mitigate risks.
• Correct the problem immediately if you can.
• Than think about the impact and risk and investigate and find the root cause to fully
understand what the underlying problem is, how big the problem is and what can happen if
no action is taken.
• The correction is to eliminate the problem
• The corrective action will eliminate the root cause
• The preventive action will eliminate the risk
• Make an action plan and see what you need (resources, budget, time).
• Check effectiveness of your actions.

31. Looking back to move forward.

32. THANK YOU
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to-prevent-problems-and-mitigate-risks-in-your-life-science-
business/

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36. Webinar
Preventing problems and
mitigating risks using CAPA