Aprašymas
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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Sincerely yours,
ComplyMarket Team
www.complymarket.com
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