We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 2016.
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here.
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
In this presentation, you'll learn:
-What your organization needs to be doing to prepare for the transition to ISO 13485:2016
-Why the transition presents an opportunity for your organization to implement better processes
-An overview of the specific changes coming with ISO 13485:2016
-The actions you should be taking now and how to plan for the implementation of the standard
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 2016.
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here.
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
In this presentation, you'll learn:
-What your organization needs to be doing to prepare for the transition to ISO 13485:2016
-Why the transition presents an opportunity for your organization to implement better processes
-An overview of the specific changes coming with ISO 13485:2016
-The actions you should be taking now and how to plan for the implementation of the standard
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
PECB Webinar: ISO 13485:201X - Dis 2 - Proposed changesPECB
The webinar covers:
• Projected timeframe for issue quarter 1 2016
• Effect of ISO9001:2015 on ISO13485:201X
• Main proposed changes to ISO13485:201X
Presenter:
This webinar was presented by David Smart, PECB Certified Trainer and Managing Director of Smart ISO Systems / Smart Mentoring.
Link of the recorded session published on YouTube: https://youtu.be/l-24Q6F4vFg
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
The primary objective of ISO 13485 certification is to standardize regulatory requirements for quality management systems. URS provide ISO 13485 certification in all India.
siddhartha consultancy services
www.scsuniversal.com
HR Consulting
Competency Mapping
Assessment Center
Mentoring
Performance Evaluation and Linking
with Reward Systems
Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation
Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey
Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs
Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Leadership
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Counseling
Competency Mapping
Psychometric Testing
ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
The primary objective of ISO 13485 certification is to standardize regulatory requirements for quality management systems. URS provide ISO 13485 certification in all India.
siddhartha consultancy services
www.scsuniversal.com
HR Consulting
Competency Mapping
Assessment Center
Mentoring
Performance Evaluation and Linking
with Reward Systems
Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation
Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey
Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs
Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Leadership
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Counseling
Competency Mapping
Psychometric Testing
ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The current ISO 13485 edition was published on 1 March 2016.
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
Presentation by Ed Ball, Senior Associate, Maetrics Ltd at the Liverpool City Region SME workshop: regulatory process and approval at The Accelerator Building, Liverpool on Thursday 6 December.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
Beyond the EU: DORA and NIS 2 Directive's Global ImpactPECB
The global implications of DORA and NIS 2 Directive are significant, extending beyond the European Union.
Amongst others, the webinar covers:
• DORA and its Implications
• Nis 2 Directive and its Implications
• How to leverage directive and regulation as a marketing tool and competitive advantage
• How to use new compliance framework to request additional budget
Presenters:
Christophe Mazzola - Senior Cyber Governance Consultant
Armed with endless Excel files, a meme catalog worthy of the best X'os (formerly twittos), and a risk register to make your favorite risk manager jealous, I swapped my computer scientist cape a few years ago for that of a (cyber) threat hunter with the honorary title of CISO.
Ah, and I am also a quadruple senior certified ISO27001/2/5, Pas mal non ? C'est francais.
Malcolm Xavier
Malcolm Xavier has been working in the Digital Industry for over 18 Years now. He has worked with Global Clients in South Africa, United States and United Kingdom. He has achieved Many Professional Certifications Like CISSP, Google Cloud Practitioner, TOGAF, Azure Cloud, ITIL v3 etc.
His core competencies include IT strategy, cybersecurity, IT infrastructure management, data center migration and consolidation, data protection and compliance, risk management and governance, and IS program development and management.
Date: April 25, 2024
Tags: Information Security, Digital Operational Resilience Act (DORA)
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Find out more about ISO training and certification services
Training: Digital Operational Resilience Act (DORA) - EN | PECB
NIS 2 Directive - EN | PECB
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
DORA, ISO/IEC 27005, and the Rise of AI: Securing the Future of CybersecurityPECB
In an era where digital transformation is inevitable, the landscape of cybersecurity is constantly evolving.
Amongst others, the webinar covers:
• DORA and its Implications
• ISO/IEC 27005: Risk Management in Information Security
• Leveraging Artificial Intelligence for Enhanced Cybersecurity
Presenters:
Geoffrey L. Taylor - Director of Cybersecurity
Geoffrey Taylor brings a wealth of experience from multiple roles within various industries throughout his career. As a Certified ISO 27001 Implementer and Auditor, as well as certified ISO 27005, CISM and CRISC, he brings a unique perspective on cybersecurity strategy, risk management and the implementation of an Information Security Management System, having helped multiple organizations in aligning their strategy based on their threat landscape.
Martin Tully - Senior Cyber Governance Consultant
Martin is a Senior Consultant at CRMG with over twenty years of experience, and has previously been employed at two of the ‘Big Four’ professional services firms. Martin has worked across most industry sectors in the development of the best practice guidance and risk analysis methodologies. Martin is also accomplished at: leading the implementation of an ISMS; delivering a number of information risk assessments; reviewing information security policies; assessing security requirements across the supply chain; and updating a complete framework of supporting standards. Prior to the ISF, Martin’s roles have included delivering operational risk reporting, running research projects and benchmarking information security investments for major clients. Martin holds a Bachelors degree from Royal Holloway University of London.
Date: March 27, 2024
Tags: ISO, ISO/IEC 27005, ISO/IEC 42001, Artificial Intelligence, Information Security, Digital Operational Resilience Act (DORA)
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Find out more about ISO training and certification services
Training: ISO/IEC 27005 Information Security Risk Management - EN | PECB
ISO/IEC 42001 Artificial Intelligence Management System - EN | PECB
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
-------------------------------------------------------------------------------
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/ffX-Xbw7XUk
Securing the Future: ISO/IEC 27001, ISO/IEC 42001, and AI GovernancePECB
In today’s rapidly evolving world, where Artificial Intelligence (AI) not only drives innovation but also presents unique challenges and opportunities, staying ahead means being informed.
Amongst others, the webinar covers:
• ISO/IEC 27001 and ISO/IEC 42001 and their key components
• Latest trends in AI Governance
• Ethical AI practices
• Benefits of Certification
Presenters:
Jeffrey Bankard - Cybersecurity & AI Leader, AI Management Systems: ISO/IEC 42001
Jeffrey provides executive leadership for AI product creation through the product incubation unit (PIU). Ensures the timely delivery of AI consulting engagements through cross-functional teams comprised of senior information and network security leaders to establish strategic goals for improving the security architecture and risk posture for clients. Consults with business leaders to define key performance indicators and service levels. Fosters employee development through mentoring and coaching. Decides how to achieve results within the organization’s strategic plans, policies, and guidelines. Develops new products and secures those products through current AI security guidelines (ISO 42001).
Adrian Resag - Experienced in Risk and Control - ISO/IEC 27001 and ISO/IEC 42001
Adrian believes a stimulating career can span many disciplines and that leading organizations value versatile professionals. He has enjoyed managing teams spanning the globe by working in world-leading organizations as Chief Audit Executive, Head of Risk Management, Information Systems Auditor, Head of Internal Control, as a consultant, a statutory auditor and an accountant. To allow such a diverse career, his approach has been to pursue certifications in many fields (making him one of the most qualified and certified in some of them). He has written books and created professional certifications in audit & assurance and compliance & ethics, and teaches in subjects from information security to risk management. With a passion for education, Adrian founded an educational institution and has taught tens of thousands of students and professionals online, in companies, universities and in governmental organizations.
Date: February 28, 2024
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Find out more about ISO training and certification services
Training: ISO/IEC 27001 Information Security Management System - EN | PECB
ISO/IEC 42001 Artificial Intelligence Management System - EN | PECB
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
YouTube video: https://youtu.be/DujXaxBhhRk
The importance of a robust cybersecurity strategy cannot be overstated. Learning on the effective measures to be taken and tools needed to navigate the evolving cybersecurity landscape successfully is essential.
Amongst others, the webinar covers:
• ISO/IEC 27002 and ISO/IEC 27032 and their key components
• Key Components of a Resilient Cybersecurity Strategy
• CMMC Frameworks
Presenters:
Dr. Oz Erdem
Governance, Risk and Compliance (GRC) consultant, trainer, auditor, and speaker
Dr. Erdem has over 25 years of experience in information security, trade compliance, data privacy, and risk management. He took leadership roles in governance and compliance at various Fortune 100-500 companies and SMBs, including Siemens Corporation, Siemens Industry, Linqs, Texas Instruments, Rtrust, ICEsoft Technologies, NATO C3A, and BILGEM. In addition, successfully managed software development (i.e., embedded, cloud, and SaaS) and digital product projects involving information security, mobile networks, and IoT networks. Further, Dr. Erdem led several non-profit organizations, such as National Association of District Export Councils (NADEC), Government Contractors Council (GovConCouncil), and Central-North Florida District Export Council as the Chairman of the Board.
Peter Geelen
Peter Geelen is the director and managing consultant at CyberMinute and Owner of Quest for Security, Belgium. Over more than 20 years, Peter has built strong experience in enterprise security & architecture, Identity & Access management, but also privacy, information & data protection, cyber- and cloud security. Last few years, the focus is on ISO/IEC 27001 and other ISO certification mechanisms. Peter is accredited Lead Auditor for ISO/IEC 27001, ISO 9001, PECB Trainer and Fellow in Privacy. Committed to continuous learning, Peter holds renowned security certificates as certified ISO/IEC 27701 lead implementer and lead auditor, ISO/IEC 27001 Master, Sr. Lead Cybersecurity Manager, ISO/IEC 27002 lead manager, ISO/IEC 27701 Lead Implementer, cDPO, Risk management, Lead Incident Mgr., Disaster Recovery, and many more.
George Usi - CEO of Omnistruct
An internet pioneer and award-winning leader in internet governance with over 25 years of experience, George Usi knows that getting hacked is not a matter of ‘if’ but, ‘when’ and the fiscal and reputational effects that has on a business, the executives, and the board. George is the Co-Founder of Omnistruct, a cyber risk company. Omnistruct protects and expands revenue creation, reputation, and customer retention through cyber risk transference, governance, and compliance. We ensure that security and privacy programs work.
Date: January 24, 2024
YouTube Video: https://youtu.be/9i5p5WFExT4
Website: https://bit.ly/3SjovIP
ISO/IEC 27001 and ISO/IEC 27035: Building a Resilient Cybersecurity Strategy ...PECB
As we approach the new year, the importance of a robust cybersecurity strategy cannot be overstated. Learning on the effective measures to be taken and tools needed to navigate the evolving cybersecurity landscape successfully is essential.
Amongst others, the webinar covers:
• ISO/IEC 27001 and ISO/IEC 27035 and their key components
• Key Components of a Resilient Cybersecurity Strategy
• Best practices for building a resilient cybersecurity strategy in 2024
Presenters:
Rinske Geerlings
Rinske is an internationally known consultant, speaker and certified Business Continuity, Information Security & Risk Management trainer.
She was awarded Alumnus of the Year 2012 of Delft University, Australian Business Woman of the Year 2010-13 by BPW, Risk Consultant of the Year 2017 (RMIA/Australasia) and Outstanding Security Consultant 2019 Finalist (OSPAs)
Rinske has consulted to the Department of Prime Minister & Cabinet, 15 Central Banks, APEC, BBC, Shell, Fuji Xerox, NIB Health Funds, ASIC, Departments of Defense, Immigration, Health, Industry, Education, Foreign Affairs and 100s of other public and private organizations across 5 continents.
She has been changing the way organizations ‘plan for the unexpected’. Her facilitation skills enable organizations to achieve their own results and simplify their processes. She applies a fresh, energetic, fun, practical, easy-to-apply, innovative approach to BCM, Security, and Risk.
Her 'alter ego' includes being a lead singer in SophieG Music and contributing to the global charity playing for Change, which provides music education to children in disadvantaged regions.
Loris Mansiamina
A Senior GRC Professional consultant for Small, Medium and large companies. Over 10 years, Loris has been assisting clients in both public and private sectors about various matters relating to Gouvernance, Risk Management and Compliance (GRC), Digital transformation, cyber security program management, ISO 27k & ISO 20k implementation, COBIT & ITIL implementation, etc.
Date: December 19, 2023
Tags: ISO, ISO/IEC 27001, ISO/IEC 27035, Cybersecurity, Information Security
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
ISO/IEC 27035 Information Security Incident Management - EN | PECB
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/yT8gxRZD_4c
ISO/IEC 27001 and ISO/IEC 27005: Managing AI Risks EffectivelyPECB
In today's rapidly evolving digital landscape, the integration of artificial intelligence (AI) in business processes is becoming increasingly essential. Hence, it is crucial to stay informed and prepared.
Amongst others, the webinar covers:
• ISO/IEC 27005 and ISO/IEC 27001 and their key components
• The standard’s alignment
• Identifying AI risks and vulnerabilities
• Implementing effective risk management strategies
Presenters:
Sabrina Feddal
With more than 16 years of background in operational security, telco as engineer and project manager for major international companies. I have founded Probe I.T in 2016 to provide my customers (both national and international) with GRC services. Winner of the 2020 award, the CEFCYS – Main French Women in cybersecurity association - jury's favorite, she remains committed on a daily basis to maintaining diversity and gender diversity in her teams.
Passionate about Law, History & Cybersecurity. She has several professional certifications acquired over the course of her career: Prince2, CISSP, Lead Implementer ISO27001, Risk Manager, University degree in Cybercrime and Digital Investigation.
Her values: excellence, discretion, professionalism.
Mike Boutwell
Mike Boutwell is a Senior Information Security Specialist with over 15 years of experience in security and 10 years of risk management experience, primarily focused on financial services. He excels in collaborating with CISOs and other executive leadership to build and implement security frameworks aligned with business objectives and developing enterprise-wide security requirements. Mike has a strong track record of securing assets worth over $1 quadrillion and delivering $100M+ projects.
Mike is a certified CISSP, CISA, CGEIT, ISO 27001 Senior Lead Implementer, ISO 27001 Senior Lead Auditor, ISO 38500 Senior Lead IT Governance Manager, ISO 27032 Senior Lead Cyber Security Manager, and Certified Non-Executive Director.
Date: November 22, 2023
Tags: ISO, ISO/IEC 27001, ISO/IEC 27005, Cybersecurity, Information Security
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
ISO/IEC 27005 Information Security Risk Management - EN | PECB
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/TtnY1vzHzns
Aligning ISO/IEC 27032:2023 and ISO/IEC 27701: Strengthening Cybersecurity Re...PECB
In today's digital age, cybersecurity is more critical than ever. Hence, it is crucial to stay informed and prepared.
Amongst others, the webinar covers:
• ISO/IEC 27032:2023 and ISO/IEC 27701 and their key components
• The standard’s alignment
• Emerging Cybersecurity Threats
• What is new to the ISO/IEC 27032:2023
Presenters:
Madhu Maganti
Madhu is a goal-oriented cybersecurity/IT advisory leader with more than 20 years of comprehensive experience leading high-performance teams with a proven track record of continuous improvement toward objectives. He is highly knowledgeable in both technical and business principles and processes.
Madhu specializes in cybersecurity risk assessments, enterprise risk management, regulatory compliance, Sarbanes-Oxley (SOX) compliance and system and organization controls (SOC) reporting.
Jeffrey Crump
Mr. Jeffrey Crump is the Principal Consultant at Arizona-based Cyber Security Training and Consulting LLC and a graduate of the Certified NIS 2 Directive Lead Implementer course. He is a Certified CMMC Assessor, Certified CMMC Professional, and Instructor. Mr. Crump is also the author of Cyber Crisis Management Planning: How to reduce cyber risk and increase organizational resilience. His book has been expanded into a triad of certification courses on cyber crisis planning, exercises, and leadership.
Date: October 25, 2023
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27032
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/a21uasr8aLs
ISO/IEC 27001 and ISO/IEC 27032:2023 - Safeguarding Your Digital TransformationPECB
Cybersecurity is an ongoing journey. The regular update and improvement of security measures is essential to stay ahead of evolving threats.
Amongst others, the webinar covers:
• Benefits of Compliance
• Digital Transformation: Why
• ISO/IEC 27001 and ISO/IEC 27032
• ISO/IEC 27001: Information Security Management System (ISMS)
• ISO/IEC 27032: Cybersecurity Framework
Presenters:
Douglas Brush
Douglas Brush is a federally court-appointed Special Master, and Court Appointed Neutral expert in high-profile litigation matters involving privacy, security, and eDiscovery.
He is an information security executive with over 30 years of entrepreneurship and professional technology experience. He is a globally recognized expert in cybersecurity, incident response, digital forensics, and information governance. In addition to serving as a CISO and leading enterprise security assessments, he has conducted hundreds of investigations involving hacking, data breaches, trade secret theft, employee malfeasance, and various other legal and compliance issues.
He is the founder and host of Cyber Security Interviews, a popular information security podcast.
Douglas is also committed to raising awareness about mental health, self-care, neurodiversity, diversity, equity, and inclusion, in the information security industry.
Malcolm Xavier
Malcolm Xavier has been working in the Digital Industry for over 18 Years now. He has worked with Global Clients in South Africa, United States and United Kingdom. He has achieved Many Professional Certifications Like CISSP, Google Cloud Practitioner, TOGAF, Azure Cloud, ITIL v3 etc.
His core competencies include IT strategy, cybersecurity, IT infrastructure management, data center migration and consolidation, data protection and compliance, risk management and governance, and IS program development and management.
Carole Njoya
Founder in 2018 of Alcees, a Paris-based management consulting fabric specialized in cybersecurity, data privacy governance and digital trust, Carole Njoya provides independent, tailored and expert advisory to companies doing business in European markets and serving both B2B and B2C customers. With more than 100 cybersecurity projects delivered, she assists entities in preparing, implementing and maintaining the right best practices under the ISO 27001 compliance framework and GDPR article 25 obligation (Privacy by design) for their vendors. Carole Njoya featured in the « Women Know Cybersecurity » 2019 Twitter list edited by Cybercrime Magazine. Carole Njoya is committed in science and engineering since pre-teen period.
Date: September 27, 2023
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27032
YouTube video: https://youtu.be/U7tyzUrh8aI
Managing ISO 31000 Framework in AI Systems - The EU ACT and other regulationsPECB
The management of AI systems is a shared responsibility. By implementing the ISO 31000 Framework and complying with emerging regulations like the EU ACT, we can jointly create a more reliable, secure, and trustworthy AI ecosystem.
Amongst others, the webinar covers:
• Understanding AI and the regulatory landscape
• AI and the threat landscape
• A risk driven approach to AI assurance - based on ISO 31000 principles
• Stress testing to evaluate risk exposure
Presenters:
Chris Jefferson
Chris is the Co-Founder and CTO at Advai. As the Co-Founder of Advai, Chris is working on the application of defensive techniques to help protect AI and Machine Learning applications from being exploited. This involves work in DevOps and MLOps to create robust and consistent products that support multiple platforms, such as cloud, local, and edge.
Nick Frost
Nick Frost is Co-founder and Lead Consultant at CRMG. Nick’s career in cyber security spanning nearly 20 years. Most recently Nick has held leadership roles at PwC as Group Head of Information Risk and at the Information Security Forum (ISF) as Principal Consultant. In particular Nick was Group Head of Information Risk for PwC designing and implementing best practice solutions that made good business sense that prioritized key risks to the organisation and helped minimize disruption to ongoing operations. Whilst at the ISF Nick led their information risk projects and delivered many of the consultancy engagements to help organisations implement leading thinking in information risk management.
Nicks combined experience as a cyber risk researcher and practitioner designing and implementing risk based solutions places him as a leading cyber risk expert. Prior to cyber security and after graduating from UCNW and Oxford Brookes Nick was a geophysicist in the Oil and Gas Industry.
Date: August 24, 2023
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-31000
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/MXnHC6AvjXc
Impact of Generative AI in Cybersecurity - How can ISO/IEC 27032 help?PECB
Generative AI offers great opportunities for innovation in various industries. Hence, by adopting ISO/IEC 27032, you can enhance your cybersecurity resilience and efficiently address the risks associated with generative AI.
Amongst others, the webinar covers:
• AI & Privacy
• Generative AI, Models & Cybersecurity
• AI & ISO/IEC 27032
Presenters:
Christian Grafenauer
Anonymization expert, privacy engineer, data protection officer, LegalTech researcher (GDPR, Blockchain, AI) Christian Grafenauer is an accomplished privacy engineer, anonymization expert, and computer science specialist, currently serving as the project lead for anonymity assessments at techgdpr. With an extensive background as a senior architect in Blockchain for IBM and years of research in the field since 2013, Christian co-founded privacy by Blockchain design to explore the potential of Blockchain technology in revolutionizing privacy and internet infrastructure. As a dedicated advocate for integrating legal and computer science disciplines, Christian’s expertise in anonymization and GDPR compliance enables innovative AI applications, ensuring a seamless fusion of technology and governance, particularly in the realm of smart contracts. In his role at techgdpr, he supports technical compliance, Blockchain, and AI initiatives, along with anonymity assessments. Christian also represents consumer interests as a member of the national Blockchain and DTL standardization committee at din (German standardization institute) in ISO/TC 307.
Akin Johnson
Akin J. Johnson is a renowned Cybersecurity Expert, known for his expertise in protecting digital systems from potential threats. With over a decade of experience in the field, Akin has developed a deep understanding of the ever-evolving cyber landscape.
Akin is an advocate for cybersecurity awareness and frequently shares his knowledge through speaking engagements, workshops, and publications. He firmly believes in the importance of educating individuals and organizations on the best practices for safeguarding their digital assets.
Lucas Falivene
Lucas is a highly experienced cybersecurity professional with a solid base in business, information systems, information security, and cybersecurity policy-making. A former Fulbright scholar with a Master of Science degree in Information Security Policy and Management at Carnegie Mellon University (Highest distinction) and a Master's degree in Information Security at the University of Buenos Aires (Class rank 1st). Lucas has participated in several trainings conducted by the FBI, INTERPOL, OAS, and SEI/CERT as well as in the development of 4 cyber ISO national standards.
Date: July 26, 2023
YouTube Link: https://youtu.be/QPDcROniUcc
GDPR and Data Protection: Ensure compliance and minimize the risk of penaltie...PECB
By embracing the importance of GDPR and leveraging ISO/IEC 27701, you can enhance your data protection practices, achieve compliance, and minimize the risk of penalties.
Amongst others, the webinar covers:
Importance of Data Protection
Understanding Data Collection and Challenges
Introduction to GDPR
Key Principles of GDPR
Who does GDPR Apply to and Its Global Implications
Introduction to ISO/IEC 27701
Implementing ISO/IEC 27701
Privacy by Design
Dealing with IT on a Daily Basis
Building Awareness and Training
Audit, Data Discovery, and Risk Assessments
Presenters:
Mike Boutwell
Mike Boutwell is a Senior Information Security Specialist with over 15 years of experience in security and 10 years of risk management experience, primarily focused on financial services. He excels in collaborating with CISOs and other executive leadership to build and implement security frameworks aligned with business objectives and developing enterprise-wide security requirements. Mike has a strong track record of securing assets worth over $1 quadrillion and delivering $100M+ projects.
Mike is a certified CISSP, CISA, CGEIT, ISO 27001 Senior Lead Implementer, ISO 27001 Senior Lead Auditor, ISO 38500 Senior Lead IT Governance Manager, ISO 27032 Senior Lead Cyber Security Manager, and Certified Non-Executive Director.
Lisa Goldsmith
Lisa Goldsmith is the founder of LJ Digital and Data Consultancy. Lisa has over 23 years’ experience of supporting leadership teams in membership, charity, and wider not-for-profit organisations to simplify their IT and digital strategy that allows them to sleep soundly at night, knowing their systems and processes are fit for purpose, GDPR compliant, secure and that they deliver value to staff, members, and stakeholders.
Prior to starting her own consultancy, Lisa gained extensive experience working for membership organisations and has knowledge and expertise at all levels of operations from working within careers and qualifications teams, as Membership Manager, as Head of Digital & IT for delivering large-scale digital, IT and GDPR compliance projects and serving on several Senior Leadership Teams. Lisa is also currently a Trustee of the BCLA and Groundwork East.
Date: June 27, 2023
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27701
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/lfJrSLaGDtc
Website: https://bit.ly/437GOnG
How Can ISO/IEC 27001 Help Organizations Align With the EU Cybersecurity Regu...PECB
The EU has implemented a range of regulations aimed at strengthening its cybersecurity posture. In this context, the ISO/IEC 27001 standard offers a comprehensive framework for managing and safeguarding sensitive information, such as personal data.
Amongst others, the webinar covers:
• Quick recap on the ISO/IEC 27001:2013 & 2022
• ISO/IEC 27001 vs legislation
• The EU Cyber Legislation landscape
• Some considerations and consequences
• How to stay on top of the ever changing context
Presenters:
Peter Geelen
Peter Geelen is the director and managing consultant at CyberMinute and Owner of Quest for Security, Belgium. Over more than 20 years, Peter has built strong experience in enterprise security & architecture, Identity & Access management, but also privacy, information & data protection, cyber- and cloud security. Last few years, the focus is on ISO/IEC 27001 and other ISO certification mechanisms. Peter is accredited Lead Auditor for ISO/IEC 27001, ISO 9001, PECB Trainer and Fellow in Privacy. Committed to continuous learning, Peter holds renowned security certificates as certified ISO/IEC 27701 lead implementer and lead auditor, ISO/IEC 27001 Master, Sr. Lead Cybersecurity Manager, ISO/IEC 27002 lead manager, ISO/IEC 27701 Lead Implementer, cDPO, Risk management, Lead Incident Mgr., Disaster Recovery, and many more.
Jean-Luc Peters
Jean-Luc Peters brings 25 years of IT technology, information and cybersecurity expertise to boards, executives, and employees. Since the younger age he has held management positions in the private and government sector. He is currently the Head of the Cyber Emergency Response team for the National Cybersecurity Authority in Belgium. In addition to this, he is also a trainer, coach and trusted advisor focusing on enhancing cyber resilience.
Jean-Luc has helped in the technical implementation of the NIS 1 (Network and Information Security) Directive transposition in Belgium, defining the Baseline Security Guidelines governmental ISMS framework and many other projects. He holds several certifications, including ISO/IEC 27001 Lead Implementer, ISO/IEC 27005 Auditor, CISSP, GISP, Prince 2 Practitioner, ITIL etc.
Date: May 31, 2023
Tags: ISO, ISO/IEC 27001, Information Security, Cybersecurity
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/rsjwwF5zlK8
ISO/IEC 27001 and ISO 22301 - How to ensure business survival against cyber a...PECB
To protect your organization from cyber attacks, you need to implement a robust information security management system (ISMS) and business continuity management system (BCMS) based on international standards, such as ISO/IEC 27001 and ISO 22301.
Amongst others, the webinar covers:
• Why we need a cyber response plan to protect business operations
• Introduction to ISO/IEC 27001 and ISO 22301
• What do we need for a cyber security response plan?
• How do we develop a cyber security response plan?
Presenters:
Nick Frost
Nick Frost is Co-founder and Lead Consultant at CRMG.
Nick’s career in cyber security spanning nearly 20 years. Most recently Nick has held leadership roles at PwC as Group Head of Information Risk and at the Information Security Forum (ISF) as Principal Consultant.
In particular Nick was Group Head of Information Risk for PwC designing and implementing best practice solutions that made good business sense, that prioritise key risks to the organisation and helped minimise disruption to ongoing operations. Whilst at the ISF Nick led their information risk projects and delivered many of the consultancy engagements to help organisations implement leading thinking in information risk management.
Nicks combined experience as a cyber risk researcher and practitioner designing and implementing risk based solutions places him as a leading cyber risk expert. Prior to cyber security and after graduating from UCNW and Oxford Brookes Nick was a geophysicst in the Oil and Gas Industry.
Simon Lacey
Simon is a resourceful, creative Information & Cyber Security professional with a proven track record of instigating change, disrupting the status quo, influencing stakeholders and developing ‘big picture’ vision across business populations. Multiple industry experience; excels in building stakeholder engagement & consensus; and suporting organisations to make sustainable change.
Simon also has considerable experience of risk management, education and awareness, strategy development and consulting to senior management and is a confident and engaging public speaker.
Simon has previously worked within the NHS, Bank of England and BUPA, before setting out as an independent consultan forming Oliver Lacey Limited, supporting clients in multiple business sectors.
When not working, Simon loves to run – currently training for the Berlin Marathon, a Director of Aylesbury United Football Club, records vlogs and is an experienced standup comic.
Date: April 26, 2023
Find out more about ISO training and certification services
Training: https://bit.ly/3AyoyYF
https://bit.ly/3LbBVTx
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
YouTube video: https://youtu.be/i4qx5mjEqio
Integrating ISO/IEC 27001 and ISO 31000 for Effective Information Security an...PECB
Integrating ISO/IEC 27001 and ISO 31000 can help organizations align their information security and risk management efforts with their overall business objectives, leading to more effective risk management and better decision-making.
Amongst others, the webinar covers:
• Aligning the ISMS process with ISO/IEC 27001
• Using ISO 31000 within the ISMS
• Aligning the RM process with ISO 31000
• How/where does ISO/IEC 27001 fit?
Presenters:
Nick Riemsdijk
As a highly experienced and multi-skilled leader in Information and Physical Security, Nick is known as a collaborative, focused, driven and highly analytical individual with a broad portfolio of successes in client engagements. His expertise spans devising, implementing, managing and delivering information security, physical security, organizational resilience and facilities management solutions for organizations. He is certified as a Certified Information Security Manager (CISM), Certified Protection Professional (CPP), in Project Management (Prince2), ISO 22301 (Business Continuity), ISO 27001 (Information Security), and ISO 31000 (Risk Management).
Rinske Geerlings
Rinske is an internationally known consultant, speaker and certified Business Continuity, Information Security & Risk Management trainer.
She was awarded Alumnus of the Year 2012 of Delft University, Australian Business Woman of the Year 2010-13 by BPW, Risk Consultant of the Year 2017 (RMIA/Australasia) and Outstanding Security Consultant 2019 Finalist (OSPAs)
Rinske has consulted to the Department of Prime Minister & Cabinet, 15 Central Banks, APEC, BBC, Shell, Fuji Xerox, NIB Health Funds, ASIC, Departments of Defense, Immigration, Health, Industry, Education, Foreign Affairs and 100s of other public and private organizations across 5 continents.
She has been changing the way organizations ‘plan for the unexpected’. Her facilitation skills enable organizations to achieve their own results and simplify their processes. She applies a fresh, energetic, fun, practical, easy-to-apply, innovative approach to BCM, Security, and Risk.
Her 'alter ego' includes being a lead singer in SophieG Music and contributing to the global charity playing for Change, which provides music education to children in disadvantaged regions.
Date: March 23, 2023
Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-31000
https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
YouTube video: https://youtu.be/Xj0U2mbpZUs
IT Governance and Information Security – How do they map?PECB
Effective IT Governance requires proper Information Security practices to ensure that the organization's data is secure. On the other hand, Information Security policies and procedures must be aligned with the organization's overall IT Governance framework to ensure that security measures do not negatively impact business operations.
Amongst others, the webinar covers:
▪ Bring Governance and InfoSec Together
▪ Answering WIIFM
▪ Business Terms
Presenters:
Dr. Edward Marchewka
Dr. Edward Marchewka is a seasoned executive that has come up through the ranks in the IT vertical, expanding into information security, quality management, and strategic planning.
Edward founded and serves as the Principal for 3LC Solutions, enabling YOU to Tell a Better Story in business, with our vCIO, vCISO, quality, and strategy consulting services, through metrics and relating risk to the business with our CHICAGO Metrics® SaaS solution.
He has also held several roles leading information technology, most recently with Gift of Hope Organ and Tissue Donor Network, leading the Information and Technology Services department as the Director of IT, Data, and Security Services. Prior to Gift of Hope, he ran information security for Chicago Public Schools.
Edward has earned a Doctorate of Business Administration from California Southern University and Masters’ degrees in Business Administration and Mathematics from Northern Illinois University. He earned Bachelors’ degrees in Liberal Studies and Nuclear Engineering Technologies from Thomas Edison State College, N.J. Edward maintains several active IT, security, and professional certifications from (ISC)2, ASQ, ITIL, PCI, PMI, ISACA, Microsoft, and CompTIA. He has held legacy IT certifications from Cisco and HP, and a designation from the National Security Agency.
Date: February 22, 2023
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-38500
https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27001
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/2bSbAdL5Idg
Student Information Session University Digital Encode.pptxPECB
oin us as our Director for Business Mustafe Bislimi teams up with Dr. Obadare Peter Adewale, our academic partner Digital Encode Limited, to provide valuable information about our programs, admissions process and specialization and elective courses.
Discover the opportunities available to you as a student at PECB University and get a firsthand look at what makes us a top choice for education.
Whether you're a prospective student or simply curious about PECB University, don't miss this informative session! Subscribe to our channel and stay tuned for more videos.
For inquiries regarding admission process contact us: university.studentaffairs@pecb.com
-EMBA in Cybersecurity: https://www.youtube.com/redirect?event=video_description&redir_token=QUFFLUhqbHJQUUpjMmY2NmcyeURhTzE5VlRSNjg2Y1hwd3xBQ3Jtc0tuLTZqdmZyWkc2VVNQV21YRTlKZUQ2SEtUenNXbzYyb1ZianV5cldDYTViWjZ1eVhCNWtxWHI3VTNwRS1BOE4wTERkZ3BtcndwM0sxdVoydWZYSXBkV2hYd2lwU0NLSTk5WERWMlhtVk1Ud2tuWTRjTQ&q=https%3A%2F%2Fpecb.university%2Fprograms%2Fmba-programs%2Fcybersecurity&v=3YJbbr708pk
-EMBA in Business Continuity Management: https://www.youtube.com/redirect?event=video_description&redir_token=QUFFLUhqa3JQTGVhd1VfeG1weWNzUzRrMmg2bk0tc3kxUXxBQ3Jtc0tsOVF5VG82TkhRU3R5TVRWWmdhMzBrSTU2eW9wby1OYWN4VTg5bkJBY0lhTmNsOFhETzB5cVp0WU8zbTQwTlZkdk9Dby1fSXdhWmRpZFFPUmk3NS1QOGpMOVBlaDFhVVpwa2JZMkxKNGRnTnppMm93SQ&q=https%3A%2F%2Fpecb.university%2Fprograms%2Fmba-programs%2Fbusiness-continuity-management&v=3YJbbr708pk
-EMBA in Governance, Risk, and Compliance: https://www.youtube.com/redirect?event=video_description&redir_token=QUFFLUhqbUplMGtjOFRWbzdGWERmdTR2QjdSbTBuQUxCd3xBQ3Jtc0tsNVdOU1p6UERWM3ZySE55V2FlWlJ1aFlzUU85VEt0aVRoR0hyTjNHbUNVYVMyb0lzTkZycUtJRzNxazlDWGRqTHZQMWJPZEYwbG1xWjVJN1JNOW1QUjJBZDY3NkU5LVl0b2xxOFpkZW1ZX2F3QmF5cw&q=https%3A%2F%2Fpecb.university%2Fprograms%2Fmba-programs%2Fgovernance-risk-compliance&v=3YJbbr708pk
Being aware of the trends that are expected to shape the digital landscape is an important step in ensuring the security of your data and online assets.
Amongst others, the webinar covers:
• Top Cyber Trends for 2023
• Cyber Insurance
• Prioritization of Cyber Risk
Presenters:
Colleen Lennox
Colleen Lennox is the Founder of Cyber Job Central, a newly formed job board dedicated to Cybersecurity job openings. Colleen has 25+ years in Technical Recruiting and loves to help other find their next great job!
Madhu Maganti
Madhu is a goal-oriented cybersecurity/IT advisory leader with more than 20 years of comprehensive experience leading high-performance teams with a proven track record of continuous improvement toward objectives. He is highly knowledgeable in both technical and business principles and processes.
Madhu specializes in cybersecurity risk assessments, enterprise risk management, regulatory compliance, Sarbanes-Oxley (SOX) compliance and system and organization controls (SOC) reporting.
Date: January 25, 2023
Tags: ISO, ISO/IEC 27032, Cybersecurity Management
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Find out more about ISO training and certification services
Training: https://pecb.com/en/education-and-certification-for-individuals/iso-iec-27032
https://pecb.com/article/cybersecurity-risk-assessment
https://pecb.com/article/a-deeper-understanding-of-cybersecurity
Webinars: https://pecb.com/webinars
Article: https://pecb.com/article
Whitepaper: https://pecb.com/whitepaper
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For more information about PECB:
Website: https://pecb.com/
LinkedIn: https://www.linkedin.com/company/pecb/
Facebook: https://www.facebook.com/PECBInternational/
Slideshare: http://www.slideshare.net/PECBCERTIFICATION
YouTube video: https://youtu.be/BAAl_PI9uRc
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
PECB Webinar: Proposed changes for medical device quality management systems and regulatory requirements
1. MEDICAL DEVICES QMS &
REGULATORY REQUIREMENTS-
PROPOSED CHANGES
BY DANNY KROO
DOCUSYS CORPORATION
docusysco@gmail.com
Copyright Docusys Corporation 2015
2. BRIEF DISCUSSION ON PROPOSED CHANGES
ISO 13485:201X
MEDICAL DEVICE SINGLE AUDIT PROGRAM
EUROPEAN REQUIREMENTS
UNANNOUNCED VISITS
AGENDA
Copyright Docusys Corporation 2015
3. DANNY KROO
President of Docusys Corporation
Established in 1994
Provide medical device quality and regulatory
consulting services.
Medical Device Lead Assessor qualified for ISO 13485,
CMDCAS, MDD, IVD, FDA, JPAL
INTRODUCTION
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4. Establish simple and cost effective systems for
customers
Simple systems easier to maintain
Advantage of being a lead assessor for a major
notified body and registrar
OBJECTIVE
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6. Why Changes?
Stakeholders such as regulatory bodies, consumers
demand improvements in safety & effectiveness
New technologies- APPS
Incidents where system has failed- PIP – breast
implant issue
Could these incidents have been avoided?
Changes
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7. Medical device quality management system
Last major change was in 2003
ISO 13485:201X
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8. ISO TC 210 WG 1 is working on new version
Meeting took place in London, England- August 25-27
Meeting dealt with internal comments from working
group
Revised draft will be circulated to WG1 members
Anticipate that FDIS will be voted on in late 2015 and
standard released in 2016.
Current status of ISO 13485:201X
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9. ISO 13485:201X will not follow the High-Level
structure requirement (Annex SL) now applicable to
all Management System Standards ( ISO 9001)
There may be an issue with alignment of ISO 13485
and ISO 9001 for some clients that have certification
to the 2 new standards.
ISO 13485 will maintain the current numbering system
and structure.
Summary of proposed changes
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10. More emphasis on risk management
More emphasis on product lice cycle management
Additional definitions (i.e. Clinical evaluation, distributor,
importer, risk management…)
Clause 4.1.5 now requires written supplier agreements, and
control of outsourced processes must be risk-based.
Clause 4.2.1.2 requires you to create and maintain a
technical file for products and product families
Clause 4.2.4 requires that patient records are maintained
as confidential records.
Summary of proposed changes
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11. Clause 5.6-include complaint-handling trends as an
input to your management review inputs
Outputs must include changes needed to the quality
system in order to address new and revised
regulatory requirements
Summary of proposed changes
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12. Clauses 6.3 –Infrastructure-Procedures required for
product
Summary of proposed changes
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13. Throughout Clause 7 there are new references to
software
Design-adding Design Transfer as Clause 7.3.8 and the
requirement for a Design and Development File (i.e.,
DHF) as Clause 7.3.10
Purchasing-strengthen supplier controls and make
them risk-based.
Summary of proposed changes
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14. UDI labeling was added as Clause 7.5.3.1
Clause 8.2.1 related to “Feedback” is now a formal input to
the risk management process
The requirement for complaint handling was added as
Clause 8.2.1.2.1
Section with requirements for control of nonconforming
product (i.e., Clause 8.3) was split into four subsections
with new requirements for nonconforming product that
has already been shipped
Summary of proposed changes
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15. Added two new data analysis requirements for audits
and service reports.
Summary of proposed changes
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16. What is MDSAP?
Developed by a group of medical device regulators to
allow recognized third-party auditors to conduct a
single audit of a medical device manufacturer that will
cover ISO 13485:2003 and their respective regulatory
requirements
Benefits organizations selling to multiple jurisdictions
One audit instead of multiple audits
Medical Device Single Audit Program
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17. Audit based on ISO 13485 by an approved Auditing
Organization and shall include as applicable,
requirements from Health Canada, US FDA, ANVISA
Brazil, Australia TGA and Japan MHLW and PMDA
Based on a three year cycle
In pilot stage
MDSAP
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18. To enable the appropriate regulatory oversight of medical
device manufacturers’ quality management systems while
minimizing regulatory burden on industry.
• To promote, in the longer term, greater alignment of
regulatory approaches and technical requirements globally
based on international standards and best practices
To promote more efficient and flexible use of regulatory
resources through work-sharing and mutual acceptance
among regulators while respecting the sovereignty of each
authority.
MDSAP OBJECTIVES
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19. Standardized Rating System for Manufacturer Audit
Findings
Standardized Rating System for Recognized Auditing
Organization
Assessment Findings
MDSAP Quality Management System
MDSAP Standardization
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20. Special Audits, Audits Conducted by Regulatory
Authorities, and Unannounced Audits are
extraordinary audits that may occur at any time
within the audit cycle
Grading of Nonconformities- minor, major
Unannounced audits to close down major NCs
MDSAP audit reports are being sent to all regulators.
MDSAP
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21. The participating regulatory authorities hope to achieve
more consistency among the auditing organizations.
By following the MDSAP Audit Model:
Audits performed for MDSAP will be conducted in a
consistent manner across auditing organizations.
Audits will be conducted logically and efficiently, with
attention to the interactions between processes.
Auditors will be able to determine whether systemic
quality management system nonconformities are present.
Benefits of MDSAP
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22. Current EU Medical Devices Directives will soon be
replaced by a new Regulation.
Expected to be adopted and published within 12 months
with implementation from 2015 to 2018.
Significant impacts on clinical, biocompatibility, preclinical
performance and other technical requirements.
For IVDs, it is uncertain whether the transition period will
be 3 or 5 years, meaning that the final implementation date
could be 2018 or 2020.
EU Medical Directives
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23. Scandals such as PIP scandal and metal-on-metal hip
joints caught the attention of the EU public at large
on the safety management of medical devices.
European Parliament issued a Resolution in June 2012,
which called for stricter approval rules for Notified
Bodies, stronger requirements for preclinical and
clinical evaluation of medical devices and mandated
unannounced inspections of medical device
manufacturers.
EU Medical Directives
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24. Changes are described in the EU Commission
proposed IVD and Medical Device regulations dated
September 26, 2012 and Parliament’s IVD and Medical
Device amendments on October 22, 2013
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EU Medical Directives
25. The European Commission will be able to review
recommendations for CE Marking prior to approval
(i.e., the scrutiny process).
The European Commission’s ability to create common
technical specifications (CTS) will be expanded to all
devices.
Only newly created Special Notified Bodies will be
able to issue CE Certificates for high-risk devices such
as implants.
EU Medical Directives
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26. Notified Bodies will be audited for compliance with
the new regulations jointly by Competent Authorities.
Until 2013, audits of Notified Bodies were performed
only by the Competent Authority from the member
state in which the Notified Body is located.
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EU Medical Directives
27. Manufacturers will be subject to unannounced audits by Notified
Bodies.
Spinal implants, devices that control and monitor active implants,
nanomaterials, apheresis machines, and combination products will
be reclassified as Class III devices requiring technical documentation
known as a design dossier.
Most in vitro diagnostics (IVDs) will require Notified Body
involvement.
A Unique Device Identification (UDI) system will be required for
labeling, and the European Databank on Medical Devices (Eudamed)
will be expanded.
Formatting of declarations of conformity and technical files will be
revised.
EU Medical Directives
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28. Notified Bodies are challenging clinical evidence not only
for new higher risk class III and IIa devices but also existing
devices that have been CE Marked since the inception of
the Directives, even those that are lower risk class IIa and I
sterile/measuring devices.
Pressure has been applied to Notified Bodies and
Competent Authorities that are charged with designating
and oversight of the Notified Bodies in the member
countries. Information about the performance of Notified
Bodies was published on June 17, 2014 in a
document “Commission Staff Working Document”
Impact of changes
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29. Audits of several Notified Bodies conducted from
February 2013 to May 2014 revealed weaknesses
among some of them and also for one of the
Competent Authorities. There are fewer Notified
Bodies than there were a few years ago, and the ones
that remain are much more vigilant.
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Impact of changes
30. Unannounced audits have become more common
since the Commission Recommendation on Notified
Body audits of September 24, 2013, which clarifies the
authority of Notified Bodies to carry out
unannounced audits of medical device
manufacturers. Until now, the EU regulatory system
enabled Europeans access to innovative medical
technologies earlier than Americans; not anymore.
Impact of changes
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31. Dedicated personnel and action plan
Securing Regulatory Affairs resources: “Qualified Person”
+ new resources for additional work
Check that they have selected the right Notified Body
Increased internal and external training to ensure full
compliance to the more stringent requirements including
those related to material safety (i.e., biocompatibility and
clinical data
Prepare for higher costs for the overall assessments and
submission fees
What should manufacturers plan
for?
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32. Prepare for longer review times for all devices, especially
class III devices, class IIb implantable devices and novel
devices
Review clinical data evaluation – get prepared for clinical
investigations for certain device types; specifically Class II
and implantable Class IIb devices
Updating Technical Files to meet the more rigorous
requirements by the implementation date
Establish SOPs (Standard Operating Procedures) and
training for handling unannounced Notified Body
inspections of themselves and critical suppliers
What should manufacturers plan
for?
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34. European medical device regulations are undergoing
many significant changes that will impact
manufacturers, suppliers, and Notified Bodies. One
major and immediate change is the EU Commission
requirement for Notified Bodies to conduct
unannounced audits on manufacturers of CE marked
products.
PIP scandal
UNANNOUNCED VISITS
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35. Frequency- at least once every three years, and this
frequency will need to be increased should the
devices be considered a high risk.
Must be unpredictable and without prior notice, so
there will be no communication with your company
prior to the audit.
The Notified Body auditors will present themselves at
your premises, and the company must provide
immediate and unrestricted access.
Unannounced Audits Process
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36. Access to your critical sub-contractors and crucial
suppliers by the Notified Body may also be required,
Subject to identical requirements, in situations where
this is likely to provide more effective control by the
Notified Body. This right of access will need to be
covered in your contracts with these suppliers.
Unannounced Audits Process
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37. Auditors arrive without notice.
Focus is usually related to manufacturing ( inspection
and test), control of suppliers and technical files
Auditors decide on following an audit trail
UNANNOUNCED AUDITS
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38. Recommend training and procedure for key personnel
such as reception, top management and QA to
understand the requirements and the process
Update contracts with key suppliers to include a
provision for unannounced visits.
UNANNOUNCED AUDITS
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