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.
The Effectiveness of the Hazard and Operability Study Methodology in Process ...PECB
ย
HAZOP is the acronym for HAZard and OPerability study. It is a structured and systematic examination of a planned or existing product, process, procedure or system. It is used to identify risks to people, equipment, environment and/or organizational objectives, focusing primarily on the design intent of the particular system.
The presentation introduces best practice approaches in conducting a HAZOP Study based on IEC Standard- 61882.
In this webinar, the presenter speaks freely of his experience in leading an actual HAZOP Study and highlights the advantages of this risk assessment technique.
Main points covered:
โข How to create awareness of the use of the Hazard and Operability (HAZOP) Methodology in process Hazard Analysis (PHA)?
โข How to familiarize Potential HAZOP Team Members with their Roles and Responsibilities in the HAZOP Examination of a Typical Facility?
A Case Summary Study Approach will be used based on the presenterโs own experience of leading an actual HAZOP Study.
Presenter:
This session was presented by PECB Trainer Jacob McLean, Principal Consultant and Managing Director of Kaizen Training & Management Consultants Limited.
Link of the recorded session published on YouTube: https://youtu.be/IvsrlHFADTo
Seven questions answered by process hazard analysisPaul Baybutt
ย
Process hazard analysis identifies hazard scenarios. It answers seven key questions to protect people, property and the environment from catastrophic accidents.
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.
The Effectiveness of the Hazard and Operability Study Methodology in Process ...PECB
ย
HAZOP is the acronym for HAZard and OPerability study. It is a structured and systematic examination of a planned or existing product, process, procedure or system. It is used to identify risks to people, equipment, environment and/or organizational objectives, focusing primarily on the design intent of the particular system.
The presentation introduces best practice approaches in conducting a HAZOP Study based on IEC Standard- 61882.
In this webinar, the presenter speaks freely of his experience in leading an actual HAZOP Study and highlights the advantages of this risk assessment technique.
Main points covered:
โข How to create awareness of the use of the Hazard and Operability (HAZOP) Methodology in process Hazard Analysis (PHA)?
โข How to familiarize Potential HAZOP Team Members with their Roles and Responsibilities in the HAZOP Examination of a Typical Facility?
A Case Summary Study Approach will be used based on the presenterโs own experience of leading an actual HAZOP Study.
Presenter:
This session was presented by PECB Trainer Jacob McLean, Principal Consultant and Managing Director of Kaizen Training & Management Consultants Limited.
Link of the recorded session published on YouTube: https://youtu.be/IvsrlHFADTo
Seven questions answered by process hazard analysisPaul Baybutt
ย
Process hazard analysis identifies hazard scenarios. It answers seven key questions to protect people, property and the environment from catastrophic accidents.
A hazard is a situation that poses a level of threat to life, health, property, or environment. Most hazards are dormant or potential, with only a theoretical risk of harm; however, once a hazard becomes "active", it can create an emergency. Hazard and possibility interact together to create risk.
Identification of hazard risks is the first step in performing a risk assessment.
Safety in your company is a top priority, have you completed a process hazard analysis recently? When you complete a thorough PHA it improves safety, benefits your employees, streamlines the process and boosts your bottom line. In this slideshow, you can learn more about what a Process Hazard Analysis is, how it is completed properly and what to do with that information.
An inherent physical or chemical characteristic that has the potential for causing harm to people, the environment, or property1
Hazards are intrinsic to a material, or its conditions of use
Examples
Hydrogen sulfide โ toxic by inhalation
Gasoline โ flammable
Moving machinery โ kinetic energy, pinch points
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
ย
You see an issue and you simply set it right, but do you make the effort to find out what is the "corrective" action behind it, so that it never re-occurs?
And, do you take another extra step to come up with a "preventive" action - so that there is no other manner that issue comes up?
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently โrisk-basedโ was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
CAPA (Corrective and Preventive Action) Management : Tonex TrainingBryan Len
ย
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA)ย management in FDA field. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course teaches you to develop an effective RCA investigation, and develop a corrective and preventive action plan suitable for the identified problems.
Learn About:
CAPA application and implementation
CAPA management
FDAโs requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
CAPA data sources, Methods of data analysis
CAPA data flow charts, CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDAโs trending principals, ECI
Non-conformances or deviations
RCA tools and methods, Brainstorming methods
More...
TONEX RCA and CAPA Management Training Format:
The course is fun and dynamic
The training is a combination of theory and practice
The theoretical section is delivered in the form of interactive presentation
The practical section includes exercising with real-world examples, individual/group activities, and hands-on workshops
Audience:
CAPA Management is a 4-day course designed for:
CRAs
Project Managers/CRA Managers
Principal Investigators
Site Research Directors/Managers
Clinical Research Coordinators
QA/QC staff
GMP personnel
All individuals who are involved in investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment.
Training Objectives:
CAPA Management training course, the attendees are able to:
Describe what RCA and CAPA are
Identify the non-compliance, Define the investigator
Discuss performance management concepts
Know the purpose of Corrective and Preventive Action
Improve their RCA and CAPA executive skills for effective site risk management
Understand the requirements in 21 CFR 820 Quality
System Regulation
Foster prevention actions
More...
Course Outline:
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
TONEX RCA and CAPA Hands-On Workshop Sample
Learn more. Request more information. Visit Tonex training website link below. Ask for anything related to CAPA (Corrective and Preventive Action) Management Training.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
Reliability Maintenance Engineering 3 - 2 Root Cause AnalysisAccendo Reliability
ย
Reliability Maintenance Engineering Day 3 session 2 Root Cause Analysis
Three day live course focused on reliability engineering for maintenance programs. Introductory material and discussion ranging from basic tools and techniques for data analysis to considerations when building or improving a program.
A hazard is a situation that poses a level of threat to life, health, property, or environment. Most hazards are dormant or potential, with only a theoretical risk of harm; however, once a hazard becomes "active", it can create an emergency. Hazard and possibility interact together to create risk.
Identification of hazard risks is the first step in performing a risk assessment.
Safety in your company is a top priority, have you completed a process hazard analysis recently? When you complete a thorough PHA it improves safety, benefits your employees, streamlines the process and boosts your bottom line. In this slideshow, you can learn more about what a Process Hazard Analysis is, how it is completed properly and what to do with that information.
An inherent physical or chemical characteristic that has the potential for causing harm to people, the environment, or property1
Hazards are intrinsic to a material, or its conditions of use
Examples
Hydrogen sulfide โ toxic by inhalation
Gasoline โ flammable
Moving machinery โ kinetic energy, pinch points
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
ย
You see an issue and you simply set it right, but do you make the effort to find out what is the "corrective" action behind it, so that it never re-occurs?
And, do you take another extra step to come up with a "preventive" action - so that there is no other manner that issue comes up?
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently โrisk-basedโ was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
CAPA (Corrective and Preventive Action) Management : Tonex TrainingBryan Len
ย
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA)ย management in FDA field. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course teaches you to develop an effective RCA investigation, and develop a corrective and preventive action plan suitable for the identified problems.
Learn About:
CAPA application and implementation
CAPA management
FDAโs requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
CAPA data sources, Methods of data analysis
CAPA data flow charts, CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDAโs trending principals, ECI
Non-conformances or deviations
RCA tools and methods, Brainstorming methods
More...
TONEX RCA and CAPA Management Training Format:
The course is fun and dynamic
The training is a combination of theory and practice
The theoretical section is delivered in the form of interactive presentation
The practical section includes exercising with real-world examples, individual/group activities, and hands-on workshops
Audience:
CAPA Management is a 4-day course designed for:
CRAs
Project Managers/CRA Managers
Principal Investigators
Site Research Directors/Managers
Clinical Research Coordinators
QA/QC staff
GMP personnel
All individuals who are involved in investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment.
Training Objectives:
CAPA Management training course, the attendees are able to:
Describe what RCA and CAPA are
Identify the non-compliance, Define the investigator
Discuss performance management concepts
Know the purpose of Corrective and Preventive Action
Improve their RCA and CAPA executive skills for effective site risk management
Understand the requirements in 21 CFR 820 Quality
System Regulation
Foster prevention actions
More...
Course Outline:
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
TONEX RCA and CAPA Hands-On Workshop Sample
Learn more. Request more information. Visit Tonex training website link below. Ask for anything related to CAPA (Corrective and Preventive Action) Management Training.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
Reliability Maintenance Engineering 3 - 2 Root Cause AnalysisAccendo Reliability
ย
Reliability Maintenance Engineering Day 3 session 2 Root Cause Analysis
Three day live course focused on reliability engineering for maintenance programs. Introductory material and discussion ranging from basic tools and techniques for data analysis to considerations when building or improving a program.
The Right Contact - Up to date information regarding contact lenses, Hyrid lenses, Soft lenses, button materials, gas permable lens and contact lens care products.
A View On Brand Portfolio Management, Innovation, Profitability And Corporate...Drthomasbrand Limited
ย
A view on how companies can manage their brand portfolios to balance incremental and radical innovation with optimal profitability and the right corporate culture.
Established in Egypt in 1989, CONCRETE's factory facilities were built in the industrial zone in 6th of October. It started off as a small company with a big dream but through steady growth and unwavering ambition, CONCRETE is now a market leader. The dream started with Amr El Hakim, founder and one of the pillars of CONCRETE. After graduating from the American University in Cairo, he pursued his passion for fashion by establishing the company and giving free reign to his designs. Later on it was acquired by ARAFA HOLDING.
From a family business to a shareholding company, CONCRETE is now part of one of the most prominent textile and clothing groups in the Middle East, ARAFA HOLDING. The size of the operations of this holding company, allows CONCRETE to be vertically integrated. In addition, the manufacturing capabilities of the group guarantee sustained dependability. This allows us to compete on an international level which is motivation to seek even higher standards.
Our shops comprise over forty stores located in the most prestigious areas of Egypt, through which we cater to the needs and tastes of the child, the teenager, and the man. We also understand that as part of the Egyptian community, we have a responsibility towards society. Donating contributions is part of our mission to help develop and advance our community.
"In the last twenty years, we have fashioned the CONCRETE persona: energetic, self-confident, carefree, and elegant. Our clothes are worn with confidence and trust. For not only are we interested in fashion, but our attitude relies on style. There is a great deal of heritage behind CONCRETE fashion, and we are proud to be a leading Egyptian fashion retailer.
Fashion is seen seasonally through the choices in colors, themes, fits, and fabrics. However, style is what makes CONCRETE stand out as a unique brand, in a world where the clothes we wear reflect who we are. That is why our customers are more sophisticated, & value the importance of quality versus money.
We are constantly looking for ways to enhance the brand. We did so recently by hiring Dino Brunori, an Italian engineer & brand consultant, renovating our shops' concept, standardizing the brand identity and enhancing the visual display of the garments in our stores. All this is part of our continued efforts to provide our customers with the best Egypt has to offer.
CONCRETE is a solid name, with solid roots, that can be trusted and relied on. Our future vision for the brand includes cementing the CONCRETE name on the global market.
The global contact lenses & intraocular lenses market was valued at US$ 13,326.3 million in 2014 and expected to grow to US$ 20,050.9 million by 2019 at a CAGR of 8.4% from 2015 to 2019.
Why Replication is Not Enough to Keep Your Business Running Axcient
ย
While you may be familiar with multiple replication products and vendors, donโt confuse the technology of data or server replication with Disaster Recovery.
Replication is not a disaster recovery solution nor does it provide business continuity. So what exactly is replication? According to TechTarget, replication is the process of copying data from one location to another over a SAN, LAN or local WAN. This provides you with multiple up-to-date copies of your data. Look at replication as an aspect of DR/BC. Although it is a key technology in order to implement a complete DR/BC plan, it needs to be combined with data deduplication, virtual servers or even the cloud. But letโs take a step back to really understand business continuity.
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
An application that looks stunning but performs poorly can cause business impact, customer dissatisfaction and higher maintenance costs.
We present an overview on the fundamentals of software testing in this presentation.
In this Quality Assurance Training session, you will learn about Types of Testing , Test Strategy and Planning, and Test Estimation Techniques. Topic covered in this session are:
โข Types of Testing
โข Test Strategy and Planning,
โข and Test Estimation Techniques
For more information, about this quality assurance training, visit this link: https://www.mindsmapped.com/courses/quality-assurance/software-testing-training-with-hands-on-project-on-e-commerce-application/
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
ย
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
ย
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
ย
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
ย
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Business Valuation Principles for EntrepreneursBen Wann
ย
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
ย
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.๐คฏ
We will dig deeper into:
1. How to capture video testimonials that convert from your audience ๐ฅ
2. How to leverage your testimonials to boost your sales ๐ฒ
3. How you can capture more CRM data to understand your audience better through video testimonials. ๐
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
ย
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
Website โ www.pmday.org
Youtube โ https://www.youtube.com/startuplviv
FB โ https://www.facebook.com/pmdayconference
Improving profitability for small businessBen Wann
ย
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
ย
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
ย
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujaratโs DholeraAvirahi City Dholera
ย
The Tata Group, a titan of Indian industry, is making waves with its advanced talks with Taiwanese chipmakers Powerchip Semiconductor Manufacturing Corporation (PSMC) and UMC Group. The goal? Establishing a cutting-edge semiconductor fabrication unit (fab) in Dholera, Gujarat. This isnโt just any project; itโs a potential game changer for Indiaโs chipmaking aspirations and a boon for investors seeking promisingย residential projects in dholera sir.
Visit : https://www.avirahi.com/blog/tata-group-dials-taiwan-for-its-chipmaking-ambition-in-gujarats-dholera/
"๐ฉ๐ฌ๐ฎ๐ผ๐ต ๐พ๐ฐ๐ป๐ฏ ๐ป๐ฑ ๐ฐ๐บ ๐ฏ๐จ๐ณ๐ญ ๐ซ๐ถ๐ต๐ฌ"
๐๐ ๐๐จ๐ฆ๐ฌ (๐๐ ๐๐จ๐ฆ๐ฆ๐ฎ๐ง๐ข๐๐๐ญ๐ข๐จ๐ง๐ฌ) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
๐๐ ๐๐จ๐ฆ๐ฌ provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
โญ ๐ ๐๐๐ญ๐ฎ๐ซ๐๐ ๐ฉ๐ซ๐จ๐ฃ๐๐๐ญ๐ฌ:
โข 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
โข SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
โขFreenBecky 1st Fan Meeting in Vietnam
โขCHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
โข WOW K-Music Festival 2023
โข Winner [CROSS] Tour in HCM
โข Super Show 9 in HCM with Super Junior
โข HCMC - Gyeongsangbuk-do Culture and Tourism Festival
โข Korean Vietnam Partnership - Fair with LG
โข Korean President visits Samsung Electronics R&D Center
โข Vietnam Food Expo with Lotte Wellfood
"๐๐ฏ๐๐ซ๐ฒ ๐๐ฏ๐๐ง๐ญ ๐ข๐ฌ ๐ ๐ฌ๐ญ๐จ๐ซ๐ฒ, ๐ ๐ฌ๐ฉ๐๐๐ข๐๐ฅ ๐ฃ๐จ๐ฎ๐ซ๐ง๐๐ฒ. ๐๐ ๐๐ฅ๐ฐ๐๐ฒ๐ฌ ๐๐๐ฅ๐ข๐๐ฏ๐ ๐ญ๐ก๐๐ญ ๐ฌ๐ก๐จ๐ซ๐ญ๐ฅ๐ฒ ๐ฒ๐จ๐ฎ ๐ฐ๐ข๐ฅ๐ฅ ๐๐ ๐ ๐ฉ๐๐ซ๐ญ ๐จ๐ ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐จ๐ซ๐ข๐๐ฌ."
Business and Operational Risks in Pharmaceutical Information
1. PREVIOUS NEXTPREVIOUS NEXT
Business and Operational risks in
handling pharmaceutical information
17TH November 2011
Adrian Hampshire, BioPharm
Parambir Singh, BioPharm
Rob van Manen, Oracle
2. PREVIOUS NEXT
Risk โ a definition
โ a situation involving exposure to danger
โ the possibility that something unpleasant or unwelcome will happen
(Oxford English Dictionary)
3. PREVIOUS NEXT
Outline
โ What are business and operational risks?
o Broad scope
โข e.g. What risks do you run if you donโt have a particular
system or process in place?
o Narrow scope
โข e.g. What risks do you run when implementing a complex
system or process?
โ What are some of the impacts if a risk occurs?
โ How can we reduce the risks?
โ What do we do about residual risks?
4. PREVIOUS NEXT
Key steps and processes involved in
a clinical trial
โข Trial design and planning
โข Obtaining regulatory approval
โข Planning and manufacturing/acquiring study drug
โข Recruiting investigators (enrolment, screening, inclusion)
โข Site start-up
โข Recruiting patients
โข Administering drug
โข Registering results
โข Raising and responding to data queries
โข Monitoring safety
โข Monitoring site execution
โข Verifying source document
โข Assembling results
โข Reconciliation
โข Analysing results
โข Reporting the trial
โข Closing the study
Each of these steps involves an
individual process that is more or less
complex.
Each process is supported/enabled
by one or more IT or manual
systems.
Each step therefore carries a number
of key risks.
5. PREVIOUS NEXT
Key risks
1. The step is not executed at all
Simple example: If there is no process and system
for monitoring safety, patients are put at risk.
2. The step is executed incorrectly or
incompletely
Simple example: If the design of the trial is
inadequate or inappropriate, the results of the
study may not answer the question that the study
was designed to answer.
Conclusion:
We need a robust and complete set of
process and systems to support those
processes throughout the lifecycle of the
study.
6. PREVIOUS NEXT
Change = Risk
Implementing a new process and system(s)
= change
Change = Risk
Risks are:
โ Strategic risks
โ Programme risks
โ Operational risks
โ Project risks
7. PREVIOUS NEXT
Management of risk
Four key actions:
โ Identify the risk
โ Assess the impact
โ Reduce the impact
โ Plan to handle the risks that canโt be eliminated
Optional fifth key action:
โ Outsource the risk
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Outsourcing risk
Sponsor outsources the trial to a CRO
โ The sponsor is paying the CRO to take on the risk, for a price.
Sponsor or CRO deploys a system to help manage any
of the clinical trial processes
โ They โoutsourceโ a proportion of the risk to the developer/
vendor of the system, again, for a price.
In both cases, the organisation shares the risk with a
supplier who, because they have executed the process
many times or have built the software through many
iterations over many years, consequently run a much
reduced level of risk.
CAVEAT: If key processes of the trial are outsourced, we
need to be clear who โownsโ the risk and takes
responsibility for addressing it.
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Commercial packages reduce risk
A pre-packaged solution:
โ Built on best practices
โ Delivers probably 80% of what the customer needs
โ Gives the organisation the choice to
o configure the system to meet the missing 20%
o change their process such that the 80% provided by the pre-
packaged solution meets 100% of requirements
โ Greatly reduces the risk because all prior implementations
and the design choices and changes made as a result of
these projects have already incurred those risks
โ Reduces validation and testing requirements because
much of this is address when the pre-packaged solution is
constructed
โ Has the potential to speed up the implementation by an
order of magnitude.
o Example: ASCEND reduces implementation time from 8-10
months to 8-10 weeks
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Two examples in detail
ASCEND
โ Reducing risk by implementing a pre-configured
version of a complex CTMS solution (Siebel
Clinical)
Parambir Singh, Vice President, Clinical Trial
Management Solutions at BioPharm Systems
Argus Safety and Empirica Signal
โ Reducing risk by implementing a commercially
available, proven and market-leading safety and
risk management solution suite
โ Rob van Manen, Master Principal Sales
Consultant at Oracle HSGBU
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Introduction
A CTMS helps mitigate the risks of:
โ Skipping a step
โ Executing a step incorrectly
Siebel Clinicalโs design is particularly helpful at mitigating risk
โ Template-driven
A pre-packaged version of Siebel Clinical, such as ASCEND, further
mitigates risk
โ Industry standards and best practices
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Agenda
Topic
Introduction & Agenda
Recruiting Investigators
Site Start-Up
Recruiting Patients
Monitoring Site Execution
Closing the Study & Conclusion
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Recruiting Investigators
Assessment Templates: Standardized evaluation criteria
and answer choices
โ Ensure investigators are evaluated consistently and objectively
โ Complete one assessment multiple times or several different
assessments for each investigator
โ Associate a percentage score with each investigator
Siebel Clinical
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Recruiting Investigators
Target Lists: Complex investigator searches
โ Allow users to search for investigators:
o in the right location
o with the right patient population
o with the right experience
o with the right assessment scores
ASCEND
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Site Start-Up
Activity Templates: Standardized sets of tasks and
documents
โ Reflect content of SOPs
โ Ensure same tasks are completed and same documents are
collected across all sites
โ Can have separate templates for each country to reflect different
requirements
Siebel Clinical
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Site Start-Up
Activities & Document Tracking: Focused tracking areas
โ Utilizing the SC separate views due to different tracking needs for
activities vs. documents
โ Tailored fields and field dropdown choices in each view
โ Document Tracking Screen which includes all documents also
includes indication of what level the document is related to
ASCEND
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Recruiting Patients
Subject Visit Templates: Standardized subject visit
schedules and payment amounts
โ Created per protocol and applied to each site and patient
o Can be versioned to reflect protocol amendments
โ Payment amounts can be modified at the site level (modifications
are documented)
โ Payment process ensures no visits are paid for more than once
Siebel Clinical
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Recruiting Patients
Subject Information: Improved tracking
โ Able to record IRB Approval dates for protocol amendments that
do not affect the visit schedule and therefore do not require new
Informed Consent
โ Able to track individual subject treatment arms and change
treatment arms mid-study
โ Able to track details about subject-specific protocol deviations and
adverse events
ASCEND
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Monitoring Site Execution
Trip Report Templates: Standardized tasks and questions
โ Reflect content of SOPs
โ One template for each type of visit
โ Created centrally and then applied to each site visit record
โ Ensure same information is recorded, tasks are completed, and
questions are answered for each visit type across all sites
Siebel Clinical
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Monitoring Site Execution
Trip Report Completion: Expanded to include more
information
โ Separated yes/no questions from narrative response questions
โ Allow relevant PD, SAE, Follow-Up Item, and CRF Tracking records
to be imported as a snapshot in time
โ Records complete approval history audit trail to comply with 21
CFR Part 11
ASCEND
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Closing the Study
Activity Templates: Standardized sets of tasks and
documents
โ Reflect content of SOPs
โ Ensure same tasks are completed and same documents are
collected across all sites
โ Can have separate templates for each country to reflect different
requirements
โ Rollup views allow quick access to subject, site, and
country/region statuses to confirm all child records are in a
terminal status
Siebel Clinical
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Closing the Study
Activities & Document Tracking: Focused tracking areas
โ Utilizing the SC separate views due to different tracking needs for
activities vs. documents
โ Tailored fields and field dropdown choices in each view
โ Document Tracking Screen which includes all documents also
includes indication of what level the document is related to
ASCEND
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Conclusion
โข Implementing a CTMS helps to mitigate risk by
providing a central location for clinical trial
management information
โข Siebel Clinical is particularly helpful at mitigating risk
due to its template-driven design
โข A pre-packaged version of Siebel Clinical, such as
ASCEND, further mitigates risk by adhering to industry
best practices and including commonly-requested
enhancements right out of the box
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Introduction
A case processing system can help mitigate process-related
compliance risks, such as:
โ Failing to comply with adverse reaction regulations
- Failing to report certain cases
- Failing to comply with regulatory reporting deadlines
A signal detection environment can contribute in mitigating
product-related risks, such as:
โ Failing to timely detect product-related adverse reactions
- Failing to perform correct clinical assessment of potential signals
- Failing to take appropriate action and document this
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Case Processing: Data Entry
Risks and safeguards:
โ Incomplete data: Data completeness checking
- Avoid missing key information such as patient, product,
event or reporter
โ Incorrect data: Data correctness checking
- Dates and numbers
- Upper and lower boundaries
โ Inconsistent data: Data consistency checking
- Starting and ending dates; continuing exposure/event
- Seriousness criteria
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Case Processing: Coding
Risks and safeguards:
โ Incorrect coding
- Use of auto-encoders, supporting powerful multi-step coding
algorithms
- Use of coding review procedures
โ Inconsistent coding
- Use of standard synonym lists
- Code propagation capabilities
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Case Processing: Medical review
Risks and safeguards:
โ Incorrect assessment of reportability
- Providing all relevant information in an easily accessible way
โ Undocumented assessments
- Importance of easy to use functionality to capture medical
assessment results (including audit trail)
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Case Processing: Regulatory reporting
Risks and safeguards:
โ Reports not submitted
- Automatic report requests based on regulatory requirements
โ Reports submitted too late
- Report tracking with reminder capabilities
โ Incorrect report type, e.g. periodic versus expedited reporting
- Reportability assessment combined with automatic report requests
โ Reports not adequately documented for auditing purposes
- Built-in report tracking and auditing
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Signal Detection
Background:
โ Regulators have published signal detection guidance documents and are
in the process of implementing signal detection requirements
โ Regulators are performing quantitative signal detection themselves and
have been confronting companies with potential signals
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Examples of Regulatory and Public-Private Initiatives
Europe:
โ ENCePP (European Network of Centres for Pharmacoepidemiology and
Pharmacovigilance)
โ IMI-PROTECT (Innovative Medicines Initiative - Pharmacoepidemiological
Research on Outcomes of Therapeutics by a European Consortium)
โ EU-ADR
US:
โ Sentinel and Mini-Sentinel
โ Observational Medical Outcomes Partnership (OMOP)
Japan:
โ Mihari
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Signal Detection Activities by Regulators
โ FDA
o Empirica Signal in production at CDER, CBER, CDRH and CFSAN - quarterly
overview of potential signals currently under evaluation
o Empirica Study and WebSDM in production at CDER and CBER
โ EMA โ EudraVigilance
o In-house developed quantitative signal detection tools (PRR)
โ MHRA
o Empirica Signal โ Signal Management in production โ Drug Analysis Prints
โ MHLW โ PMDA
o Developing quantitative signal detection tools as part of the Mihari initiative
โ Other countries:
o Netherlands (Lareb): In-house quantitative signal detection tools (ROR)
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Signal Detection: Risks and Safeguards
Risks:
โ Non-compliance with current regulatory guidelines and upcoming
regulations with respect to quantitative safety signal detection
โ Previously unknown signals identified by regulators through quantitative
safety signal detection
Safeguards:
โ Implementation of processes and systems for standardized, systematic,
documented quantitative signal detection and signal management
โ Application of methods and systems for data cleaning and signal
detection as similar as possible to those used by the authorities
