This document discusses compliance risks in international trade and proposes a systematic approach to managing those risks. It outlines various regulatory areas that pose compliance risks, such as export controls, customs classification, and sanctions. It then compares a compliance program to the Hazard Analysis Critical Control Point (HACCP) model, which takes a preventative approach to identifying and controlling risks. The document provides an example of applying this model to export controls compliance in the defense sector.
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given device...
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given device...
Managing New Requirement for Economic Operator RegimeErik Vollebregt
Presentation of new economic operator regime under the new EU Medical Devices and IVDs Regulations, delivered at the Q1 Medical Devices Regulation conference on 16 July 2019
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
This presentation describes regulatory hurdles to keep in mind when acquiring / selling medical devices companies with CE certificates to prevent them from becoming invalid.
The Quality Metrics Program is an FDA initiative aiming to collect data on certain manufacturing processes from biopharmaceutical companies through an electronic portal.
This presentation describes the impact of the program and its challenges for the industry.
Presentation at the Advamed MedTech conference in Boston on 25 September regarding the state of implementation of the EU Medical Devices Regulation MDR, and what companies can still do before its date of application on 26 May 2020
GS42 Item 12 Technical Guidelines and updated standards: position update, by ...FAO
Presentation by by M.McLaws (EuFMD)to the 42nd General Session of the EuFMD, 20-21 April 2017
http://www.fao.org/ag/againfo/commissions/eufmd/commissions/eufmd-home/reports/general-sessions/en/
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
Presentation on the World Trade Organization's Agreement on Technical Barriers to Trade.
Developed by the International Trade Team of Barral M Jorge & Associates
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Medical Device European Authorized RepresentativeMonir EL AZZOUZI
Non-EU Medical Device Manufacturer need a European Authorized Representative with an agreement to sell product in Europe. Learn Roles and Responsibilities and how to choose one. Free checklist available and list of existing Authorized Representative. Why you should not choose your distributor as a EC REP
Discussion of how foreign distribution structure affects export compliance and provides risk management guidelines for managing foreign distribution export compliance issues
Managing New Requirement for Economic Operator RegimeErik Vollebregt
Presentation of new economic operator regime under the new EU Medical Devices and IVDs Regulations, delivered at the Q1 Medical Devices Regulation conference on 16 July 2019
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
This presentation describes regulatory hurdles to keep in mind when acquiring / selling medical devices companies with CE certificates to prevent them from becoming invalid.
The Quality Metrics Program is an FDA initiative aiming to collect data on certain manufacturing processes from biopharmaceutical companies through an electronic portal.
This presentation describes the impact of the program and its challenges for the industry.
Presentation at the Advamed MedTech conference in Boston on 25 September regarding the state of implementation of the EU Medical Devices Regulation MDR, and what companies can still do before its date of application on 26 May 2020
GS42 Item 12 Technical Guidelines and updated standards: position update, by ...FAO
Presentation by by M.McLaws (EuFMD)to the 42nd General Session of the EuFMD, 20-21 April 2017
http://www.fao.org/ag/againfo/commissions/eufmd/commissions/eufmd-home/reports/general-sessions/en/
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
Presentation on the World Trade Organization's Agreement on Technical Barriers to Trade.
Developed by the International Trade Team of Barral M Jorge & Associates
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Medical Device European Authorized RepresentativeMonir EL AZZOUZI
Non-EU Medical Device Manufacturer need a European Authorized Representative with an agreement to sell product in Europe. Learn Roles and Responsibilities and how to choose one. Free checklist available and list of existing Authorized Representative. Why you should not choose your distributor as a EC REP
Discussion of how foreign distribution structure affects export compliance and provides risk management guidelines for managing foreign distribution export compliance issues
With ACE has come a more powerful experience in post entry management and other transactions that take place after clearance. It’s no longer the old manual processes of yesteryear. It is now more automated and robust, providing new features for traders to streamline their customs transactions and a more sophisticated way for Customs to monitor levels of compliance.
Een presentatie van The Compliance Factory (+31 345 531700) omtrent de problematiek die voortvloeit uit rechtsgebieden in geval van onjuiste behandeling van inhuurcontracten met o.a. Zelfstandigen (ZZP-ers). Plus oplossingen.
Training Slides of Certified Compliance Officer to enhance Personal Development, discussing the importance of Compliance.
Some Key-Points:
- The Framework of Compliance
- Corporate Governance
- Compliance Program
For further information regarding the course, please contact:
info@asia-masters.com
www.asia-masters.com
Compliance Risk Assessment Fall 2016 Class 4 Stephen Paine.docxaryan532920
Compliance Risk Assessment
Fall 2016 Class 4
Stephen Paine
Compliance Risk Assessment
Overview
Recap of Class 1
Pfizer Case Study and Compliance Risks
Legal and Regulatory Incentives/Conflicts of Interest
Political Failure of Controls
Reputational Recidivism
Point of Sale/Distribution
Definitions
Compliance Risk is the risk of failing to comply with applicable legal or regulatory requirements resulting in a material loss (financial or reputational) or legal/regulatory sanction
A Compliance Risk Assessment is a framework to enable the evaluation and analysis of the overall Compliance risk (both inherent risks and control effectiveness) associated with a particular business area
Recap of Class 2
The Five Elements of an Effective Compliance Program
Tone at the Top
Enron Chronology: July 1985 Enron established through merger and by November 2006 entire senior management team has either been indicted or convicted with Enron and Arthur Andersen no longer operating
Corporate Culture and Communication
Codes of Conduct set the values for employees to follow and those values are based on Compliance Risk.
3. Compliance Risk Assessment
4. Testing and Monitoring
5. Chief Compliance Officer
Case Study: HSBC
Financing drug cartels
Permitting sanctioned regimes to process dollar payments
Claw back of compensation (including Compliance Officers)
Criminal charges for “failure to maintain an effective AML program”
Recap of Class 3
Compliance Tools/Controls
Advisory Function
Coverage of Front Office and Technology, Finance and Operations
Conflicts of Interest -- A Deep Dive
Conflicts of interest are inherent in the financial services business
Historical success of the industry has been managing these conflicts by eliminating or disclosing them
Top to bottom review of business operations to address conflicts of interest of every kind
Risk Assessments
Follow-Up
Policies and Procedures
Education and Training
Compliance Surveillance and Business Unit Review and Testing
‹#›
In the News This Week
The Wells Fargo Cross-Selling Matter
Consent Order
Unauthorized Deposit Accounts and Simulated Funding
Unauthorized Credit Cards
Unauthorized Enrollments into Online Banking
Unauthorized Debit Cards
Independent Consultant’s Remit
Pay Redress Costs to Customers
$185 Million in Civil Penalties and Fines
Compliance Monitoring (page 23)
John Stumpf, Wells Fargo CEO, Appears before Senate Committee on Banking
http://www.cnn.com/videos/cnnmoney/2016/09/21/elizabeth-warren-wells-fargo-ceo-cnnmoney.cnn
‹#›
Our Journey So Far
Class 1
Class 2
Class 3
Tonight . . . finally
Compliance Risk
Compliance Program
Compliance Controls
Compliance Risk Assessment
Compliance Risk Assessment
A Compliance Risk Assessment is a framework to enable the evaluation and analysis of the overall Compliance risk (both inherent ri ...
Exploring Relationship Between Risk & ComplianceComplianceTrack
• How to identify compliance risks in the business
• How to involve risk management in compliance management
• Integrating compliance risks with useful management tools
Learning technologies 2014: The Trickle Down Effect of ComplianceNetDimensions
This presentation looks at how learning technologies and processes from highly regulated industries are filtering down to non compliance orientated businesses. We will focus on examples from Aviation and Life Sciences industries and how these can benefit the broader community.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
EAC certification, custom union, cu tr certificate, TR CU certificate, Ukrsepro Certificate, Atex Certificate, CE Mark, technical passport, fire certificate, ISO, ISI, CE, RDSO, SSI, Trademark, Copy right, Patents, GOST-R, ERP, Wesite development, Scanning Solution, Information Security, ISO 9001/14001/18001/22001/27001/50001/TS 16949/17025/13485, Pollution Consent, Environment Audit, safety Audit, Training for Internal Auditor, IRCA approved Lead Auditor for ISO 9001/14001/18001/22001/27001, Six Sigma Green Belt, Black Belt, Total Quality management, NSIC Registration,5S, Kaizan, TQM,TPM, Lean Six Sigma,Quality Circle,IT Security,ITes
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
This presentation presents how Quality Risk management can be applied in Commissioning & Qualification of Facility , System and Equipments in Pharmaceutical Facilities.
Chapter 9Audit Risk AssessmentPrepared by Dr Phil Saj1.docxmccormicknadine86
Chapter 9
Audit Risk Assessment
Prepared by Dr Phil Saj
1
Learning objectives
Appreciate the importance of audit risk assessment and why it is linked to financial statement assertions.
Explain the importance of business risks in audit planning.
Describe the procedures performed by an auditor to assess risk.
Appreciate the importance of internal control to an entity and to its independent auditors.
2
Learning objectives
Indicate the procedures for obtaining and documenting an understanding of the entity’s internal control.
Explain why and how a preliminary assessment of control risk is made.
Explain the importance of the concept of audit risk and its three components.
3
Management’s financial statement assertions
Existence or occurrence
Assets or liabilities of the entity exist at a given date and whether recorded transactions or events have occurred during the period.
Completeness
Transactions, events and accounts that should be presented in the financial statement are included.
Cut-off
All transactions, events and accounts have been recorded in the correct period.
4
Management’s financial statement assertions
Rights and obligations
Assets represent rights of the entity and liabilities
are the obligations of the entity at a given date.
Valuation and allocation
Asset, liability, components have been included in the
financial statements at the appropriate amounts.
Accuracy
Transactions have been appropriately recorded
in the proper accounts.
5
Management’s financial statement assertions
Presentation and disclosure
Particular components of the financial statements are
properly classified, described and disclosed.
Refer to the textbook Table 9.1, page 363, for illustrations of each of these assertions.
6
Business risk assessment
A business risk approach allows the auditor to:
Identify threats faced by the organisation.
Recognises that most business risks will eventually
have an effect on the financial statements.
Increase the chances of identifying risks of material
misstatements in the financial reports
Categories of business risk:
Financial risk
Operational risk
Compliance risk
7
Risk assessment procedures
Enquiries
Management, staff, internal auditors, company bankers,
legal advisors.
Analytical procedures
Provide a broad indication of the likelihood of possible
errors.
Observations and inspections
Inspection of manuals, visiting business premises,
observing procedures taking place.
8
Importance of internal control
The Committee of Sponsoring Organisations (COSO) of
the Treadway Commission defines internal control as:
a process, effected by an entity’s board of directors,
management and other personnel, designed to
provide reasonable assurance regarding the
achievement of objectives in the following categories:
Effectiveness and efficiency of ...
This presentation f=gives Overview of Quality Risk Management Process and presents case studies for application of QRM in Manufacturing Operations.
◦ Drug Substance Attributes
◦ Excipient Selection
◦ Process Selection
◦ Formulation Development & Optimisation
◦ “Manufacturing Process Development
A summary of the 8 key steps to ensure compliance with UK export controls, based on the Government's Code of Practice, combined with best practice tips from across industry. Plus what to do if you discover a possible violation.
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
JMeter webinar - integration with InfluxDB and GrafanaRTTS
Watch this recorded webinar about real-time monitoring of application performance. See how to integrate Apache JMeter, the open-source leader in performance testing, with InfluxDB, the open-source time-series database, and Grafana, the open-source analytics and visualization application.
In this webinar, we will review the benefits of leveraging InfluxDB and Grafana when executing load tests and demonstrate how these tools are used to visualize performance metrics.
Length: 30 minutes
Session Overview
-------------------------------------------
During this webinar, we will cover the following topics while demonstrating the integrations of JMeter, InfluxDB and Grafana:
- What out-of-the-box solutions are available for real-time monitoring JMeter tests?
- What are the benefits of integrating InfluxDB and Grafana into the load testing stack?
- Which features are provided by Grafana?
- Demonstration of InfluxDB and Grafana using a practice web application
To view the webinar recording, go to:
https://www.rttsweb.com/jmeter-integration-webinar
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
Kubernetes & AI - Beauty and the Beast !?! @KCD Istanbul 2024Tobias Schneck
As AI technology is pushing into IT I was wondering myself, as an “infrastructure container kubernetes guy”, how get this fancy AI technology get managed from an infrastructure operational view? Is it possible to apply our lovely cloud native principals as well? What benefit’s both technologies could bring to each other?
Let me take this questions and provide you a short journey through existing deployment models and use cases for AI software. On practical examples, we discuss what cloud/on-premise strategy we may need for applying it to our own infrastructure to get it to work from an enterprise perspective. I want to give an overview about infrastructure requirements and technologies, what could be beneficial or limiting your AI use cases in an enterprise environment. An interactive Demo will give you some insides, what approaches I got already working for real.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
Software Delivery At the Speed of AI: Inflectra Invests In AI-Powered QualityInflectra
In this insightful webinar, Inflectra explores how artificial intelligence (AI) is transforming software development and testing. Discover how AI-powered tools are revolutionizing every stage of the software development lifecycle (SDLC), from design and prototyping to testing, deployment, and monitoring.
Learn about:
• The Future of Testing: How AI is shifting testing towards verification, analysis, and higher-level skills, while reducing repetitive tasks.
• Test Automation: How AI-powered test case generation, optimization, and self-healing tests are making testing more efficient and effective.
• Visual Testing: Explore the emerging capabilities of AI in visual testing and how it's set to revolutionize UI verification.
• Inflectra's AI Solutions: See demonstrations of Inflectra's cutting-edge AI tools like the ChatGPT plugin and Azure Open AI platform, designed to streamline your testing process.
Whether you're a developer, tester, or QA professional, this webinar will give you valuable insights into how AI is shaping the future of software delivery.
Generating a custom Ruby SDK for your web service or Rails API using Smithyg2nightmarescribd
Have you ever wanted a Ruby client API to communicate with your web service? Smithy is a protocol-agnostic language for defining services and SDKs. Smithy Ruby is an implementation of Smithy that generates a Ruby SDK using a Smithy model. In this talk, we will explore Smithy and Smithy Ruby to learn how to generate custom feature-rich SDKs that can communicate with any web service, such as a Rails JSON API.
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
![Risk Determination International Trade Compliance ICPA Jasper Helder, Baker & McKenzie, Amsterdam [email_address]](https://image.slidesharecdn.com/amsdms878016v1icpajune2010riskdetermination-12766676090503-phpapp02/85/Risk-Determination-in-Export-Compliance-1-320.jpg)
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