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Product compliance risks can damage your brand name, lead to big financial fines and even to prison in some cases. Having a robust product compliance management system according to ISO 37301 can mitigate the risk, because you company can defend itself in a legal dispute based on implementing a product compliance management system. In this webinar, we will discuss an overview of the key elements of a product compliance management system.

✨ Participation fees: Free of Charge Webinar ✨.

? When: July 8, 2024, from 15:00 to 16:00 (European Central Time).

? Location: Online/MS teams.

? How to attend:

To participate in the workshop, please register:

Register using this registration form:

https://complymarket.com/en/events/how-to-create-a-product-compliance-management-system-iso-37301-in-a-nutshell

Or contact us if you would like to make a wire transfer.

If you are unable to register using the registration form, you can email us at complymarket@complymarket.com

?Workshop Agenda:

Introduction

• Brief overview of PCMS
• Introduction to IDW PS 980 and its relevance to the PCMS
• Importance of product compliance in today's market

Module 1: Product Compliance Culture

• Subelements of Product Compliance Culture
• Insights from Practice related to product compliance challenges
• Emphasis on the Responsibility of the Executive Board and Product Managers

Module 2: Product Compliance Objectives

• Positioning of Product Compliance Objectives within the organization
• Approach to Setting Product Compliance Objectives
• Definition and Scope of Product Compliance Objectives
• Insights from Practice in product compliance scenario planning
• Identification of Relevant Regulatory Areas for products (new IDW PS 980)

Module 3: Product Compliance Risks

• Risk Relevance Analysis for product development and launch
• Product Compliance Risk Assessment during the product lifecycle
• Integration of product risks into Enterprise-wide Risk Management
• Actions to Address Risks and Opportunities specifically for products

Module 4: Product Compliance Program

• Types of Regulations impacting product development
• Implementation of Internal Corporate Regulations for product compliance
• External Impact of Regulations on product marketing and sales
• Measures to Limit Product Compliance Risks

Module 5: Product Compliance Organization

• Delegation of product compliance tasks
• Location and Design of the Product Compliance Organization
• Resource Equipment needed for effective product compliance

Module 6: Product Compliance Communication

• Sustainability of the Communication Concept in product marketing and labeling
• Building Knowledge on Product Compliance within sales and marketing teams
• Internal Reporting Obligations related to product incidents
• External Compliance and Crisis Communication related to products

Module 7: Monitoring and Improvement of the PCMS

• Documentation Requirement for product compliance records
• Monitoring Measures for product compliance
• Reaction to Weaknesses and Violations in product compliance
• Continual Improvement in product compliance processes

Module 8: Understanding Product Context within the Organization

• Assessing the organizational environment for product development
• Understanding the Needs and Expectations of Interested Parties concerning product features and compliance
• Determining the Scope of the Product Compliance Management System

Module 9: Leadership in Product Compliance

• Leadership and Commitment to product compliance
• Governing Body and Top Management's role in ensuring product compliance
• Product Compliance Policy development

Module 10: Support for Product Compliance

• Resources needed for effective product compliance management
• Competence building for product managers and compliance officers
• Awareness campaigns within the organization on product compliance
• Documented Information and record-keeping for product compliance

Module 11: Operationalizing Product Compliance

• Operational Planning and Control for product launches
• Establishing Controls and Procedures for product design and testing
• Processes to handle concerns related to product compliance
• Investigation Processes for product compliance violations

Module 12: Performance Evaluation of PCMS

• Monitoring, Measurement, Analysis, and Evaluation of product compliance metrics
• Internal Audit of product compliance processes
• Management Review of product compliance outcomes

Module 13: Legal Developments and Adjustments in Product Compliance

• Understanding changes in product-related regulations and standards
• Necessary Adaptation to Newer Announcements and guidelines for products

Conclusion

• Recap of key learnings specific to product compliance
• Next steps and action items for ensuring ongoing product compliance

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ComplyMarket Team

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