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
Healthcare plans are customized for each client. Insurance companies have to incorporate all changes negotiated for each customer into their automated system.
Carole-Ann will present techniques that have been adopted by Healthcare Insurers to reduce the number of business rules into their systems, and therefore reduce the maintenance on their traditionally creeping systems.
Root Cause Analysis: Smarter Tools for Better Accuracy & SpeedSafetyChain Software
Review the goals, benefits, and processes for root cause analysis and look at “smarter” tools consistent with the FDA’s New Era Blueprint that enable quality and safety teams to arrive at the root cause quicker - and prevent recurrence of problems.
Overview of the apporach to non-compliances and related matters. Appropriate training for analysts on how to perform the tests and steps to take when obtaining OOS results should be implemented . The use of root cause analysis tools when finding an OOS should also be available for review.
FSMA Intentional Adulteration (IA) Rule with Rod Wheeler - Feb. 2019SafetyChain Software
Join special guest Rod Wheeler, CEO of The
Global Food Defense Institute, as he clarifies FSMA’s IA rule
requirements and serves up tools that help large food
manufacturers and processors identify their vulnerabilities in
two days or less.
Food companies will gain a clear understanding of IA compliance requirements and the knowledge they need to write their food security and defense plans including:
- How to conduct your own vulnerability assessment in 2 days
or less
- Using the FDA’s Food Defense Mitigation Strategies
database...It’s easy!
- What security countermeasures are available to consider to
mitigate the risk of intentional tampering at a food plant
- Using your vulnerability assessment to help build your Food
Defense Plans
About the Presenter, Rod Wheeler
Rod Wheeler Global Food Defense Institute
Rod Wheeler is the Founder and CEO of The Global Food
Defense Institute, the only global firm that focuses solely on
food defense, intentional adulteration (IA), tampering, and
intelligence. As a former Crime Analyst for the Fox News
Channel and frequent guest on several national and
international news outlets, he is a leading expert on food
security, terrorism and crime.
Healthcare plans are customized for each client. Insurance companies have to incorporate all changes negotiated for each customer into their automated system.
Carole-Ann will present techniques that have been adopted by Healthcare Insurers to reduce the number of business rules into their systems, and therefore reduce the maintenance on their traditionally creeping systems.
Root Cause Analysis: Smarter Tools for Better Accuracy & SpeedSafetyChain Software
Review the goals, benefits, and processes for root cause analysis and look at “smarter” tools consistent with the FDA’s New Era Blueprint that enable quality and safety teams to arrive at the root cause quicker - and prevent recurrence of problems.
Overview of the apporach to non-compliances and related matters. Appropriate training for analysts on how to perform the tests and steps to take when obtaining OOS results should be implemented . The use of root cause analysis tools when finding an OOS should also be available for review.
FSMA Intentional Adulteration (IA) Rule with Rod Wheeler - Feb. 2019SafetyChain Software
Join special guest Rod Wheeler, CEO of The
Global Food Defense Institute, as he clarifies FSMA’s IA rule
requirements and serves up tools that help large food
manufacturers and processors identify their vulnerabilities in
two days or less.
Food companies will gain a clear understanding of IA compliance requirements and the knowledge they need to write their food security and defense plans including:
- How to conduct your own vulnerability assessment in 2 days
or less
- Using the FDA’s Food Defense Mitigation Strategies
database...It’s easy!
- What security countermeasures are available to consider to
mitigate the risk of intentional tampering at a food plant
- Using your vulnerability assessment to help build your Food
Defense Plans
About the Presenter, Rod Wheeler
Rod Wheeler Global Food Defense Institute
Rod Wheeler is the Founder and CEO of The Global Food
Defense Institute, the only global firm that focuses solely on
food defense, intentional adulteration (IA), tampering, and
intelligence. As a former Crime Analyst for the Fox News
Channel and frequent guest on several national and
international news outlets, he is a leading expert on food
security, terrorism and crime.
Startupfest 2012 - The age of entrepreneurial enlightenmentStartupfest
Today’s early-stage companies are obsessed with data. They rely on analytics to understand every facet of their business, optimizing the way they acquire and engage customers, how they spread the word, and how they extract revenue. After all, you can’t improve what you can’t measure. But this obsession with data has a cost. What if you’re optimizing the wrong things? What if you’re already better than the rest of the industry in one dimension, but falling behind in another? How would you know? In this session, Bjoern Herrmann shares his research into thousands of startups. Working closely with entrepreneurial visionaries like Steve Blank, Bjoern and his team have collected and analyzed the key performance indicators of a broad range of startups, and codified this data into a system that understands what “normal” looks like.
Mr. Thomas J. Chapel - Measure that Make a Difference! WHY Measure and WHAT t...John Blue
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More presentations at http://swinecast.com/2015-niaa-symposium-antibiotics-stewardship-from-metrics-to-management
Check out this introduction to Lean processes in a health care setting—touching on 5 keys to Lean success. This presentation is from a recent AORN webinar, which is available for replay at http://bit.ly/188O2uQ. Get complete Lean instruction and tools for implementation during a workshop in Denver, CO; more information on these August and September events available at http://bit.ly/14B9gLu.
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P&G is a leader in supply chain management. With more than 60B$ in annual revenues, the Company understands that their processes can be overwhelming for small technology providers? What to do? Create a process and an organization to drive innovation. In this presentation, from the Supply Chain Insights Global Summit 2019, Michael Miller, explains the process.
Recorded webinar: http://slidesha.re/1tGIZaH
Subscribe: http://www.ksmartin.com/subscribe
Purchase the book: http://bit.ly/TOObk
Effective problem solving is not an innate skill that most people are born with.
Even for those few few lucky ones who are born with natural problem-solving talent, it is often drummed out of them by parents, teachers, and bosses. And those whose academic preparation would lead you to believe that they're highly skilled in this area (such as engineers and physicians) regularly fall prey to sloppy problem solving.
The good news is that effective problem solving is a skill that can be developed. Everyone can learn to solve problems effectively given the will and ample practice with a skilled coach/teacher.
This webinar focuses on the P (plan) phase of the PDSA/PDCA cycle (plan-do-study-adjust), which is the most difficult phase of scientific problem solving for people to master. Topics include:
• Setting a target condition
• Problem clarification
• Scoping and qualifying the problem
• Root cause analysis
Watch this lively discussion and learn the important first steps for closing the gap between where you are and where you'd like or need to be.
As preparation for the webinar, you may want to read the Discipline chapter in Karen's Shingo Award-winning book, The Outstanding Organization. www.ksmartin.com/TOO
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Suddenly the risk-reward balance has shifted dramatically. Anyone with basic cold symptoms is being advised to stay home. And many people can no longer travel with COVID-19 in their community.
What if you can no longer visit your sites? Are you ready to use the tools at your disposal as contingency or risk-mitigation strategies to keep your studies going and ensure your patients can access their study medication and remain safely monitored?
During this virtual discussion forum were putting our minds together to combat the impact of the Coronavirus outbreak on clinical trials, and be better prepared in the future.
Loss Exposures in the Restaurant Class of Business 08-2011DPSchneider
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Learn more about how Seuss+ can help you at our website www.seuss.plus
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Learn more about how Seuss+ can help you at our website www.seuss.plus
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More presentations at http://swinecast.com/2015-niaa-symposium-antibiotics-stewardship-from-metrics-to-management
Check out this introduction to Lean processes in a health care setting—touching on 5 keys to Lean success. This presentation is from a recent AORN webinar, which is available for replay at http://bit.ly/188O2uQ. Get complete Lean instruction and tools for implementation during a workshop in Denver, CO; more information on these August and September events available at http://bit.ly/14B9gLu.
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Recorded webinar: http://slidesha.re/1tGIZaH
Subscribe: http://www.ksmartin.com/subscribe
Purchase the book: http://bit.ly/TOObk
Effective problem solving is not an innate skill that most people are born with.
Even for those few few lucky ones who are born with natural problem-solving talent, it is often drummed out of them by parents, teachers, and bosses. And those whose academic preparation would lead you to believe that they're highly skilled in this area (such as engineers and physicians) regularly fall prey to sloppy problem solving.
The good news is that effective problem solving is a skill that can be developed. Everyone can learn to solve problems effectively given the will and ample practice with a skilled coach/teacher.
This webinar focuses on the P (plan) phase of the PDSA/PDCA cycle (plan-do-study-adjust), which is the most difficult phase of scientific problem solving for people to master. Topics include:
• Setting a target condition
• Problem clarification
• Scoping and qualifying the problem
• Root cause analysis
Watch this lively discussion and learn the important first steps for closing the gap between where you are and where you'd like or need to be.
As preparation for the webinar, you may want to read the Discipline chapter in Karen's Shingo Award-winning book, The Outstanding Organization. www.ksmartin.com/TOO
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One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
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CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
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Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
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3. Life Science Consulting
Accelerate
Assets
We offer the complete spectrum of vendor
selection, vendor management,
governance, oversight, contract
negotiations, compliance, risk, marketing,
and strategy.
Organizational Development
Growth and
Change
Our multifaceted team of expert trainers
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
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.
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
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
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
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
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
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
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
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.
32. THANK YOU
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business/
33. “We believe that building
a robust partnership
model is grounded in the
identification of trusted
vendors and long-term
partners who share your
values, strategic goals,
and ambitions.“
34. Seuss+ is a collaborative and trusted
international life science consultancy. We
creatively solve complex business challenges
so our clients can focus on what they do
best—science.
We support drug development program
success and organizational growth through
our unique partner approach and portfolio
of tailored and strategic business solutions.
Unraveling complex business
challenges in life sciences
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