This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
This two-day seminar on assuring data integrity in the life sciences industry will take place on September 1-2 in San Francisco and September 15-16 in Boston. It will provide an interactive forum for participants to learn from a subject matter expert about establishing effective controls and techniques for ensuring the integrity of paper-based and electronic data. The seminar will address recent data integrity case studies and regulations, and provide templates for developing data integrity standard operating procedures and validation approaches. Attendees will include personnel from quality assurance, IT, manufacturing, and regulatory groups seeking to understand challenges of data integrity assurance in light of increased regulatory scrutiny.
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
Project Management for Computer Systems ValidationAnita Anzo
Scheduled On : Thursday, November 7, 2013 at 12:00 noon
Duration: 120 minutes
this webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050
The document announces a webinar on regulatory documents for medical devices, including the Design History File, Device Master Record, Device History Record, and Technical File. The webinar will cover ensuring these documents are accurate, accessible to operators, and contain all required production and testing data. It will take place on February 29, 2012 from 1-2pm EST. Early bird discounts are available using the promo code "CGO15". The speaker is Angela Bazigos, CEO of Touchstone Technologies, with almost 30 years of experience in the life sciences industry.
The document provides an overview of the Payment Card Industry Data Security Standard (PCI DSS). It discusses what PCI compliance is and why it is important. It outlines the goals and 12 requirements of the PCI DSS, including building a secure network, protecting cardholder data, maintaining vulnerability management, access control measures, monitoring networks, and maintaining an information security policy. It also discusses how to achieve and maintain compliance to avoid fines. The document provides information on PCI compliance requirements, processes, policies, controls, project management, and key messages around PCI.
This document summarizes a 2-day in-person seminar on documenting software for FDA submissions that will take place in San Francisco, CA. The seminar, led by Brian Shoemaker, will discuss how to reconcile agile development methods with regulatory documentation requirements. It will provide guidance on documenting requirements, design, tests, hazards, and traceability throughout development while maintaining an agile approach. Attendees will learn how to address reviews and approvals without slowing development and how to demonstrate traceability naturally. The seminar aims to show how properly applying agile principles within a quality system can satisfy regulators' expectations for well-documented products.
PCI and Remote Vendors: Eliminating the complexity - Free Guide
To meet PCI requirements, CIOs and compliance officers must ensure user accountability.
When it comes to privileged users, the requirements and complexities are all magnified, especially when these privileged users happen to be third-party remote vendors.
This whitepaper highlights the PCI issues relating to remote vendors, and provides a straightforward solution for how to achieve compliancy. Particular attention is placed on:
- Clarity of what your log contains (as per PCI 10.2)
- Securing the audit logs against admin users (as per PCI 10.5)
- Eliminating anonymity (as per PCI 8 and PCI 10.1)
- Verifying awareness of corporate policy (as per PCI 12.5)
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
This two-day seminar on assuring data integrity in the life sciences industry will take place on September 1-2 in San Francisco and September 15-16 in Boston. It will provide an interactive forum for participants to learn from a subject matter expert about establishing effective controls and techniques for ensuring the integrity of paper-based and electronic data. The seminar will address recent data integrity case studies and regulations, and provide templates for developing data integrity standard operating procedures and validation approaches. Attendees will include personnel from quality assurance, IT, manufacturing, and regulatory groups seeking to understand challenges of data integrity assurance in light of increased regulatory scrutiny.
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
Project Management for Computer Systems ValidationAnita Anzo
Scheduled On : Thursday, November 7, 2013 at 12:00 noon
Duration: 120 minutes
this webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050
The document announces a webinar on regulatory documents for medical devices, including the Design History File, Device Master Record, Device History Record, and Technical File. The webinar will cover ensuring these documents are accurate, accessible to operators, and contain all required production and testing data. It will take place on February 29, 2012 from 1-2pm EST. Early bird discounts are available using the promo code "CGO15". The speaker is Angela Bazigos, CEO of Touchstone Technologies, with almost 30 years of experience in the life sciences industry.
The document provides an overview of the Payment Card Industry Data Security Standard (PCI DSS). It discusses what PCI compliance is and why it is important. It outlines the goals and 12 requirements of the PCI DSS, including building a secure network, protecting cardholder data, maintaining vulnerability management, access control measures, monitoring networks, and maintaining an information security policy. It also discusses how to achieve and maintain compliance to avoid fines. The document provides information on PCI compliance requirements, processes, policies, controls, project management, and key messages around PCI.
This document summarizes a 2-day in-person seminar on documenting software for FDA submissions that will take place in San Francisco, CA. The seminar, led by Brian Shoemaker, will discuss how to reconcile agile development methods with regulatory documentation requirements. It will provide guidance on documenting requirements, design, tests, hazards, and traceability throughout development while maintaining an agile approach. Attendees will learn how to address reviews and approvals without slowing development and how to demonstrate traceability naturally. The seminar aims to show how properly applying agile principles within a quality system can satisfy regulators' expectations for well-documented products.
PCI and Remote Vendors: Eliminating the complexity - Free Guide
To meet PCI requirements, CIOs and compliance officers must ensure user accountability.
When it comes to privileged users, the requirements and complexities are all magnified, especially when these privileged users happen to be third-party remote vendors.
This whitepaper highlights the PCI issues relating to remote vendors, and provides a straightforward solution for how to achieve compliancy. Particular attention is placed on:
- Clarity of what your log contains (as per PCI 10.2)
- Securing the audit logs against admin users (as per PCI 10.5)
- Eliminating anonymity (as per PCI 8 and PCI 10.1)
- Verifying awareness of corporate policy (as per PCI 12.5)
An organization can achieve transparency over application quality for outsourced Application Development and Maintenance (ADM) with assessments from CAST. You gain objective measurement to monitor compliance with development best practices and architectural guidelines, reducing risk and increasing transferability between teams.
The 21 CFR Part 11 Compliance Checklist for Digital ApplicationsEMMAIntl
Are digital applications better than paper-based systems? Without a doubt, yes. Applications replace large cabinets of paper storage with a small computer. They not only save space and paper but also offer quick data or document search with easy updates. But there is one component where paper-based systems are better than applications and that is maintaining signatures. Physical signatures cannot be easily replicated. As a software developer, I have successfully developed complex dynamic forms with nested search queries, but it makes me ponder how can I validate a digital record or a signature that would make my developed system as reliable as a paper-based document management system?
The document discusses CAST Application Intelligence Platform (CAST AIP), which provides objective monitoring and measurement of software applications to ensure adherence to architectural standards, coding best practices, and documentation standards. CAST AIP analyzes entire applications across all tiers and languages. It provides metrics on the application's structural integrity, changeability, robustness, performance, security, and maintainability. The platform also enables architects to drill down to specific code issues, check compliance with custom rules and standards, and define architectural policies for governance. CAST AIP analyzes applications using three engines that assess quality, compliance, and structure, and stores results in a knowledge base for reporting and decision making.
Sample IT Best Practices Audit report.
An objective, self service tool for CIO’s by CIOs.
Identify and prioritize issues.
Solve the root causes.
Justify Investments.
Improve user productivity.
Maximize existing assets.
Reduce IT costs.
Improve IT service.
Reallocate IT resources to drive the business.
Certificate management problems amount to three main points:
Certificates Expiring Unexpectedly
Compliance Concerns
General Certificate Management Chaos
Don't risk losing your services or being non-compliant.
William Boggs is a senior technical architect with over 30 years of experience developing and implementing information technology solutions. He specializes in areas like single sign-on, end user experience, interoperability, and biometric identification. Mr. Boggs has worked with companies like Siemens and Cerner to design security and networking solutions that help healthcare organizations achieve their business goals.
CipherTechs provides security auditing and assessment services to help clients meet compliance requirements, develop security policies, and evaluate controls. Their services include external and internal network vulnerability assessments, web application assessments, and policy development assistance. Audits are intended to verify that security objectives are being accomplished through appropriate controls and provide assurance through compliance validation, policy review, and security testing.
Nowadays, IT operations are required to run on a tight budget and under constant watch. Compliance, security and mobile innovation are making proper auditing of IT systems absolutely necessary. Knowing the most fundamental facts, like who changed what, when, and where, will save hours of troubleshooting, satisfy compliance needs, and secure the environment. This white paper shows a methodical approach to IT infrastructure auditing. That includes proper planning, estimation of time needed to implement an effective IT auditing solution, and critical resources.
The document discusses preparing for and conducting software license audits. It notes that software vendors are increasingly conducting audits both to ensure compliance and as a revenue stream. The document outlines common reasons for unintentional non-compliance, such as changes in licensing terms or upgrades/downgrades. It recommends companies conduct internal self-audits using the same scrutiny as vendors to identify issues and develop remediation plans. Engaging specialists experienced in vendor licensing can help optimize audit outcomes through identifying compliance gaps, interpreting terms favorably, and negotiating penalties.
Analyzing Your Government Contract Cybersecurity ComplianceRobert E Jones
Govology
Left Brain Professionals Inc.
The FAR and DAR Councils issued new cybersecurity rules for government contractors. The FAR rule, effective in June 2016, affects all government contractors and lists 15 items "a prudent business person would employ…even if not covered by this rule." The DFARS rule, 252.204-7012 "Safeguarding Covered Defense Information and Cyber Incident Reporting" requires compliance with NIST (SP) 800-171 R1, a more robust guideline, by December 31, 2017. While no audit plan or third-party system approval process exists for the FAR and DFARS rules, contractors imply compliance by signing and accepting contracts with these clauses. More importantly, these clauses exist in current contracts so your compliance is already implied. Join me for a conversation about the unique cybersecurity requirements for government and defense contractors as we discuss CUI, the audit and survey process, the costs of non-compliance, and compliance strategies.
Kaseya: Managing Remote IT Systems from Your Office: 5 Tips for Education IT Directors
Jared Henry, IT Director
Wills Point Independent School District
Gary Frenkel, IT Support Specialist
The Wharton School - Graduate Division
Wave 14 - Winodws 7 Security Story Core by MVP Azra RizalQuek Lilian
Windows 7 provides improved security features for IT professionals to securely manage networks and protect data. It builds on the security foundations of Windows Vista with enhancements such as streamlined user account control, enhanced auditing capabilities, new remote access features like DirectAccess, and data protection tools including AppLocker, Internet Explorer 8, and expanded BitLocker and RMS capabilities. These features allow organizations to securely manage networks and infrastructure, protect users and data, and provide secure access to corporate resources from any location.
See how IT Risks Impacts your Business. CAST help you to check on software performance, stability, maintainability, and security vulnerabilities in which CAST excels and successfully differentiates from code analyzers.CAST’s Application Intelligence Platform and Rapid Portfolio Analysis solutions can help you avoid these types of “software glitches” or "software risks" by allowing you to gain greater visibility through automated code review that identifies the root causes of risks before they become production problems, while expediting time-to-market with shorter release time lines and improved business agility.
Analyzing Your GovCon Cybersecurity ComplianceRobert E Jones
APTAC Spring Training Conference 2018
Left Brain Professionals Inc.
The FAR and DAR Councils issued new cybersecurity rules for government contractors. The FAR rule, effective in June 2016, affects all government contractors and lists 15 items "a prudent business person would employ…even if not covered by this rule." The DFARS rule, 252.204-7012 "Safeguarding Covered Defense Information and Cyber Incident Reporting" requires compliance with NIST (SP) 800-171 R1, a more robust guideline, by December 31, 2017. While no audit plan or third-party system approval process exists for the FAR and DFARS rules, contractors imply compliance by signing and accepting contracts with these clauses. More importantly, these clauses exist in current contracts so your compliance is already implied. Join me for a conversation about practical steps toward cybersecurity compliance. We'll talk about the unique cybersecurity requirements for government and defense contractors, walk through the categories of NIST 800-171 compliance, and discuss the audit and survey process.
Evaluating an IT network is an important but often ignored task that can provide insights into how well the network supports a company's objectives. A thorough evaluation should not just rely on user feedback, but also examine specific criteria like data backup and recovery plans, security implementations, connectivity, infrastructure health, and whether the network enables or hinders business goals. Regular network evaluations are necessary to ensure a company's network continues to drive business achievements rather than struggle to keep up with demands.
New IDC Research on Software Analysis & MeasurementCAST
Watch this exciting webinar with Melinda Ballou, a leading analyst with IDC, as she reviews the newly defined market category of Software Quality Analysis and Measurement (SQAM). Hear Melinda discuss the motivation behind increased spend on SQAM such as competitive pressures requiring rapid adaptability while avoiding software failure, complex sourcing environments that include onshore, offshore and open source options, and economic impacts that drive efficiency and accountability in development.
To view the webinar, visit http://www.castsoftware.com/news-events/event/idc-software-analysis-measurement?gad=ss
Anjali submitted a document in partial fulfillment of a Master's degree. The document discusses SafeNet's Rights Management Solution (RMS) software licensing system. RMS allows software vendors to implement flexible licensing models and enforce license terms to reduce piracy. Anjali's role in an RMS project was to find and fix bugs in the RMS automation testing suite and validate it across platforms like Linux, Solaris, and Windows using the Valgrind memory debugging tool.
Best Practices for Intelligent ComplianceBMC Software
How do you keep yourself from being a victim of the next hacking scandal? Move beyond compliance to intelligent compliance to close the Security/Operations gap.
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
An organization can achieve transparency over application quality for outsourced Application Development and Maintenance (ADM) with assessments from CAST. You gain objective measurement to monitor compliance with development best practices and architectural guidelines, reducing risk and increasing transferability between teams.
The 21 CFR Part 11 Compliance Checklist for Digital ApplicationsEMMAIntl
Are digital applications better than paper-based systems? Without a doubt, yes. Applications replace large cabinets of paper storage with a small computer. They not only save space and paper but also offer quick data or document search with easy updates. But there is one component where paper-based systems are better than applications and that is maintaining signatures. Physical signatures cannot be easily replicated. As a software developer, I have successfully developed complex dynamic forms with nested search queries, but it makes me ponder how can I validate a digital record or a signature that would make my developed system as reliable as a paper-based document management system?
The document discusses CAST Application Intelligence Platform (CAST AIP), which provides objective monitoring and measurement of software applications to ensure adherence to architectural standards, coding best practices, and documentation standards. CAST AIP analyzes entire applications across all tiers and languages. It provides metrics on the application's structural integrity, changeability, robustness, performance, security, and maintainability. The platform also enables architects to drill down to specific code issues, check compliance with custom rules and standards, and define architectural policies for governance. CAST AIP analyzes applications using three engines that assess quality, compliance, and structure, and stores results in a knowledge base for reporting and decision making.
Sample IT Best Practices Audit report.
An objective, self service tool for CIO’s by CIOs.
Identify and prioritize issues.
Solve the root causes.
Justify Investments.
Improve user productivity.
Maximize existing assets.
Reduce IT costs.
Improve IT service.
Reallocate IT resources to drive the business.
Certificate management problems amount to three main points:
Certificates Expiring Unexpectedly
Compliance Concerns
General Certificate Management Chaos
Don't risk losing your services or being non-compliant.
William Boggs is a senior technical architect with over 30 years of experience developing and implementing information technology solutions. He specializes in areas like single sign-on, end user experience, interoperability, and biometric identification. Mr. Boggs has worked with companies like Siemens and Cerner to design security and networking solutions that help healthcare organizations achieve their business goals.
CipherTechs provides security auditing and assessment services to help clients meet compliance requirements, develop security policies, and evaluate controls. Their services include external and internal network vulnerability assessments, web application assessments, and policy development assistance. Audits are intended to verify that security objectives are being accomplished through appropriate controls and provide assurance through compliance validation, policy review, and security testing.
Nowadays, IT operations are required to run on a tight budget and under constant watch. Compliance, security and mobile innovation are making proper auditing of IT systems absolutely necessary. Knowing the most fundamental facts, like who changed what, when, and where, will save hours of troubleshooting, satisfy compliance needs, and secure the environment. This white paper shows a methodical approach to IT infrastructure auditing. That includes proper planning, estimation of time needed to implement an effective IT auditing solution, and critical resources.
The document discusses preparing for and conducting software license audits. It notes that software vendors are increasingly conducting audits both to ensure compliance and as a revenue stream. The document outlines common reasons for unintentional non-compliance, such as changes in licensing terms or upgrades/downgrades. It recommends companies conduct internal self-audits using the same scrutiny as vendors to identify issues and develop remediation plans. Engaging specialists experienced in vendor licensing can help optimize audit outcomes through identifying compliance gaps, interpreting terms favorably, and negotiating penalties.
Analyzing Your Government Contract Cybersecurity ComplianceRobert E Jones
Govology
Left Brain Professionals Inc.
The FAR and DAR Councils issued new cybersecurity rules for government contractors. The FAR rule, effective in June 2016, affects all government contractors and lists 15 items "a prudent business person would employ…even if not covered by this rule." The DFARS rule, 252.204-7012 "Safeguarding Covered Defense Information and Cyber Incident Reporting" requires compliance with NIST (SP) 800-171 R1, a more robust guideline, by December 31, 2017. While no audit plan or third-party system approval process exists for the FAR and DFARS rules, contractors imply compliance by signing and accepting contracts with these clauses. More importantly, these clauses exist in current contracts so your compliance is already implied. Join me for a conversation about the unique cybersecurity requirements for government and defense contractors as we discuss CUI, the audit and survey process, the costs of non-compliance, and compliance strategies.
Kaseya: Managing Remote IT Systems from Your Office: 5 Tips for Education IT Directors
Jared Henry, IT Director
Wills Point Independent School District
Gary Frenkel, IT Support Specialist
The Wharton School - Graduate Division
Wave 14 - Winodws 7 Security Story Core by MVP Azra RizalQuek Lilian
Windows 7 provides improved security features for IT professionals to securely manage networks and protect data. It builds on the security foundations of Windows Vista with enhancements such as streamlined user account control, enhanced auditing capabilities, new remote access features like DirectAccess, and data protection tools including AppLocker, Internet Explorer 8, and expanded BitLocker and RMS capabilities. These features allow organizations to securely manage networks and infrastructure, protect users and data, and provide secure access to corporate resources from any location.
See how IT Risks Impacts your Business. CAST help you to check on software performance, stability, maintainability, and security vulnerabilities in which CAST excels and successfully differentiates from code analyzers.CAST’s Application Intelligence Platform and Rapid Portfolio Analysis solutions can help you avoid these types of “software glitches” or "software risks" by allowing you to gain greater visibility through automated code review that identifies the root causes of risks before they become production problems, while expediting time-to-market with shorter release time lines and improved business agility.
Analyzing Your GovCon Cybersecurity ComplianceRobert E Jones
APTAC Spring Training Conference 2018
Left Brain Professionals Inc.
The FAR and DAR Councils issued new cybersecurity rules for government contractors. The FAR rule, effective in June 2016, affects all government contractors and lists 15 items "a prudent business person would employ…even if not covered by this rule." The DFARS rule, 252.204-7012 "Safeguarding Covered Defense Information and Cyber Incident Reporting" requires compliance with NIST (SP) 800-171 R1, a more robust guideline, by December 31, 2017. While no audit plan or third-party system approval process exists for the FAR and DFARS rules, contractors imply compliance by signing and accepting contracts with these clauses. More importantly, these clauses exist in current contracts so your compliance is already implied. Join me for a conversation about practical steps toward cybersecurity compliance. We'll talk about the unique cybersecurity requirements for government and defense contractors, walk through the categories of NIST 800-171 compliance, and discuss the audit and survey process.
Evaluating an IT network is an important but often ignored task that can provide insights into how well the network supports a company's objectives. A thorough evaluation should not just rely on user feedback, but also examine specific criteria like data backup and recovery plans, security implementations, connectivity, infrastructure health, and whether the network enables or hinders business goals. Regular network evaluations are necessary to ensure a company's network continues to drive business achievements rather than struggle to keep up with demands.
New IDC Research on Software Analysis & MeasurementCAST
Watch this exciting webinar with Melinda Ballou, a leading analyst with IDC, as she reviews the newly defined market category of Software Quality Analysis and Measurement (SQAM). Hear Melinda discuss the motivation behind increased spend on SQAM such as competitive pressures requiring rapid adaptability while avoiding software failure, complex sourcing environments that include onshore, offshore and open source options, and economic impacts that drive efficiency and accountability in development.
To view the webinar, visit http://www.castsoftware.com/news-events/event/idc-software-analysis-measurement?gad=ss
Anjali submitted a document in partial fulfillment of a Master's degree. The document discusses SafeNet's Rights Management Solution (RMS) software licensing system. RMS allows software vendors to implement flexible licensing models and enforce license terms to reduce piracy. Anjali's role in an RMS project was to find and fix bugs in the RMS automation testing suite and validate it across platforms like Linux, Solaris, and Windows using the Valgrind memory debugging tool.
Best Practices for Intelligent ComplianceBMC Software
How do you keep yourself from being a victim of the next hacking scandal? Move beyond compliance to intelligent compliance to close the Security/Operations gap.
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304.
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following
DevOps for Highly Regulated EnvironmentsDevOps.com
Financial institutions, medical groups, governmental organizations, automotive companies… these types of entities all have unique and sometimes difficult-to-meet regulations. You may be required to have fine-grained auditability of your SDLC or maintain specific third-party integrations. Security models may be heightened, or certain types of compliance processes maintained. So how are we supposed to “do the DevOps” when we have so many things to worry about? In this webinar, we’ll explore some ways that you can adopt DevOps best practices and even (gasp!) thrive when building your DevOps and DevSecOps pipelines in highly-regulated industries.
This webinar describes a 10-step risk-based approach to validating COTS software in order to reduce costs and documentation requirements by up to two-thirds. Attendees will learn how to link requirements, risk management, and testing to efficiently validate computer systems. The speaker is an industry expert who has completed over 200 validation projects and authored a book on risk-based software validation.
TrustArc Webinar - Unified Trust Center for Privacy, Security, Compliance, an...TrustArc
In today's digital world, trust is key to customer relationships, but keeping it is a huge challenge. Customers are well-informed and empowered, quick to change brands if their trust is broken, even if it costs them more. This puts a lot of pressure on organizations to handle trust and safety issues with great care and transparency.
The challenge, however, is real. Fragmented solutions have left privacy, legal, and security teams in a perpetual cycle of catch-up, struggling to update privacy notices, manage customer data rights, and answer lengthy security questionnaires—all while trying to prove ROI to the business. It's a thankless job, filled with repetition, tedious tasks, and constant interdepartmental coordination. Combine this with fast regulatory changes and the quick evolution of AI, and it becomes overwhelming.
Join this webinar to learn more about TrustArc's new innovative solution Trust Center, the only unified, no-code online hub for trust and safety information built for privacy, security, compliance, and legal teams. Trust Center streamlines your path to compliance, shortens the pre-sales cycle, and reduces both legal and regulatory risks, saving time, effort, and cost.
This webinar will review:
- Why companies are building unified Trust Centers for a robust privacy program.
- How unified Trust Centers streamline sales cycles, ensure regulatory compliance, and reduce operational bottlenecks.
- How compliance, legal, security, GRC, and privacy teams benefit from a unified Trust Center in terms of needs, pains, and outcomes.
- How TrustArc Trust Center saves time and work while reducing legal, reputational, and compliance risk by effectively managing policies, notices, terms, and disclosures, and providing real-time updates on subprocessors.
Richard Machanoff is an independent IT consultant who provides "Rent a CIO" services to small and mid-sized companies. He has 25 years of experience in IT leadership roles across various sectors. He can help organizations maximize their investment in IT and assist with FDA 21 CFR part 11 compliance. Part 11 permits electronic records and signatures to be equivalent to paper but sets criteria for systems to ensure accuracy, reliability, and security. Compliance requires measures like system validation, audit logs, backups, access controls, and documented processes for systems and personnel. Computer system validation is a key part of the compliance approach.
This document provides an overview of key considerations for businesses that are evaluating taking their operations electronic and managing vendors to provide electronic systems and services. It discusses assessing needs, whether to build solutions in-house or buy from vendors, evaluating vendors, conducting requests for proposals, "sandbox testing" of finalist systems, and important issues to address in contracts with vendors.
The document is a curriculum vitae for Vinod Panchal. It summarizes his career objective, work experience, skills and qualifications. The summary highlights that he has over 7 years of experience as a QA lead supporting web applications. He has experience with projects involving regulations like FATCA and CRS. His technical skills include testing tools, databases, programming languages and bug reporting tools.
Why Choose the Nalpeiron Licensing Service vs. Building Your OwnJon Gillespie-Brown
Historically many ISVs have built their own licensing due to lack of flexible or cost-effective enough solutions to their needs, but with the advent of standards today, such as web services and new vendors like Nalpeiron who offer a modern hosted paradigm, many of those previous barriers to outsourcing have been removed.
So why has licensing lagged behind?
Download this white paper now to discover the real costs, risks, and issues associated with Software License Management solutions.
why FDA at my Facility is, and what do I do During an InspectionGlobalCompliancePanel
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
This document discusses 4 essential eDiscovery features that legal teams should consider to gain a competitive advantage: 1) TAR 2.0 technology that can automate document review through machine learning, 2) Secure cloud-based collaboration tools to allow remote work, 3) Language identification and translation capabilities to efficiently process foreign language documents, and 4) Holistic technical support throughout the eDiscovery process to reduce delays and free up internal resources. Adopting these features can help legal teams work more accurately, efficiently and securely.
This presentation provides information and tips to assist accountants and audits in introducing cloud technologies into their business. Auditflow - www.auditflow.com - offers a range of innovative audit compliance solutions. Mediasphere - www.mediasphere.com.au - builds websites and client portals for accountants and auditors globally.
Contact Tony Carrucan on tonyc@mediasphere.com.au for more information
The document discusses Microsoft's Business Productivity Online Suite (BPOS), which provides online versions of Microsoft productivity and collaboration tools. It highlights key features of BPOS including enterprise-class security, reliability, simplified management for IT administrators, familiar user experience, and lower total cost of ownership compared to on-premises solutions. Customer stories are provided showing how BPOS has helped small and medium-sized businesses improve productivity, communication, mobility and reduced IT costs and challenges.
Businesses involved in mergers and acquisitions must exercise due di.docxdewhirstichabod
Businesses involved in mergers and acquisitions must exercise due diligence in ensuring that the technology environment of the future organization is robust and adequately protects their information assets and intellectual property.. Such an effort requires time and open sharing to understand the physical locations, computing environment, and any gaps to address. Lack of information sharing can lead to a problematic systems integration and hamper the building of a cohesive enterprise security posture for the merged organization.
Often the urgency of companies undergoing a merger and acquisition (M&A) impedes comprehensive due diligence, especially in cybersecurity. This creates greater challenges for the cybersecurity engineering architect, who typically leads the cybersecurity assessment effort and creates the roadmap for the new enterprise security solution for the future organization. However, the business interest and urgency in completing the merger can also represent an opportunity for CISOs to leverage additional resources and executive attention on strategic security matters.
In this project, you will create a report on system security issues during an M&A. The details of your report, which will also include an executive briefing and summary, can be found in the final step of the project.
There are nine steps to the project. The project as a whole should take two weeks to complete. Begin with the workplace scenario and then continue to Step 1.
Deliverable
Cybersecurity for a Successful Acquisition, Slides to Support Executive Briefing
Step 1: Conduct a Policy Gap Analysis
As you begin Step 1 of your system security report on cybersecurity for mergers and acquisitions, keep in mind that the networks of companies going through an M&A can be subject to cyberattack. As you work through this step and the others, keep these questions in mind:
Are companies going through an M&A prone to more attacks or more focused attacks?
If so, what is the appropriate course of action?
Should the M&A activities be kept confidential?
Now, look at the existing security policies in regard to the acquisition of the media streaming company. You have to explain to the executives that before any systems are integrated, their security policies will need to be reviewed.
Conduct a policy gap analysis to ensure the target company's security policies follow relevant industry standards as well as local, state, and national laws and regulations. In other words, you need to make sure the new company will not inherit any statutory or regulatory noncompliance from either of the two original companies. This step would also identify what, if any, laws and regulations the target company is subject to. If those are different from the laws and regulations the acquiring company is subject to, then this document should answer the following questions:
How would you identify the differences?
How would you learn about the relevant laws and regulations?
How would .
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21 cfr part 11 compliance for software validation and saa s
1. 2-day In-person Seminar:
Knowledge, a Way Forward…
21 CFR Part 11 compliance for software
validation and SaaS/Cloud
Singapore
July 10th and 11th, 2017
8:30 AM to 5:00 PM
David Nettleton
Price: $1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
Computer System Validation's principal, David
Nettleton is an industry leader, author, and teacher for 21 CFR Part
11, Annex 11, HIPAA, software validation, and computer system
validation. He is involved with the development, purchase, installation,
operation and maintenance of computerized systems used in FDA
compliant applications.
This interactive two-day course explores proven techniques for
reducing costs associated with implementing, using, and
maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting
involved with Software as a Service (SaaS) and cloud computing.
These vendors are not regulated and therefore regulated
companies must ensure compliance for both infrastructure
qualification and computer system validation. It is the regulated
company that wants to avoid FDA form 483s and warning letters.
The seminar is intended for regulated companies, software
vendors, and SaaS/Cloud providers.
The instructor addresses the latest computer system industry
standards for data security, data transfer, audit trails, electronic
records and signatures, software validation, and computer system
validation.
Today the FDA performs both GxP and Part 11 inspections, the
Europeans have released an updated Annex 11 regulation that
expands Part 11 requirements and companies must update their
systems and processes to maintain compliance.
$8,475.00
Price: $5,085.00 You Save: $3,390.0 (40%)*
Register for 5 attendees
FDA Compliance Specialist,
2. Global
CompliancePanel
Agenda:
Day One Day Two
2-day In-person Seminar:
21 CFR Part 11 compliance for software validation and SaaS/Cloud
Lecture 1: Ten-Step Process for COTS Risk-Based
Computer System Validation
Learn which documents the FDA expects to
audit.
How to use the risk-based validation approach
to lower costs.
How to link requirements, specifications, risk
management, and testing.
Document a computer system validation
project using easy to understand fill-in-the-
blank templates.
Based on: "Risk-Based Software Validation -
Ten Easy Steps" (Davis Horwood International
and PDA - www.pda.org, 2006).
Lecture 1: Introduction to the FDA
How the regulations help your company to be
successful
Which data and systems are subject to Part 11
Lecture 2: 21 CFR Part 11/Annex 11 - Compliance for
Electronic Records and Signatures
What Part 11 means to you, not just what it
says in the regulations
Avoid 483 and Warning Letters
Explore the three primary areas of Part 11
compliance: SOPs, software product features,
and validation documentation
How SaaS/cloud computing changes
qualification and validation
Ensure data integrity, security, and protect
intellectual property
Understand the current computer system
industry standards for security, data transfer,
and audit trails
Electronic signatures, digital pens, and
biometric signatures
SOPs required for the IT infrastructure
Product features to look for when purchasing
COTS software
Reduce validation resources by using easy to
understand fill-in-the-blank validation
documents
Lecture 3: The Five Keys to COTS Computer System
Validation
The Who, What, Where, When, and Why of
CSV
Lecture 2: How to Write Requirements and Specifications
Workshop for writing requirements and then
expanding them for specifications
Lecture 3: How to Conduct a Hazard Analysis/Risk
Assessment-Exercise
Step-by-step instructions for performing and
documenting a risk assessment, and how to
use the results to reduce validation
documentation.
Lecture 4: Software Testing
Reduce testing by writing test cases that trace
to elements of risk management.
How to write efficient test cases
Lecture 5: System Change Control
How to manage a validated system with
minimal documentation
Lecture 6: Purchasing COTS Software
How to purchase COTS software and evaluate
software vendors.
Lecture 7: Cost Reduction Without Increasing Regulatory or
Business Risk
How to save money
How to increase quality
How to increase compliance with less
documentation
3. Global
CompliancePanel
www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
7
9
1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
3
4
5
6
Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
8
Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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2-day In-person Seminar:
21 CFR Part 11 compliance for software validation and SaaS/Cloud