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Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas.

Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices.

What is the difference between Compliance Risk Management and Product Risk Management? What about acceptability criteria for Compliance Risk Management? Should we merge the Compliance Risk Management activities into the existing Risk Management for Products? What are the expectations for managing risk in Pharmaceuticals (cGMP)? How does the evolving landscape of Compliance Risk Management interface with the evolving landscape of Combination Products?

In this one day workshop, you will learn how to implement effective Compliance Risk Management in your organization. It is important that key personnel understand what a successful implementation of both ERM and Product Risk Management (ISO 14971) looks like. There are existing tools that may be adapted to implement the new requirements efficiently.

Learning Objective:

Upon completing this course participants should:

  • Read and understand what the expectations are for manufacturers of Medical Devices, Pharmaceuticals, and Combination Products that will be regulated by ISO 13485.
  • Understand how to utilize a risk-based approach to addressing Compliance Risk Management requirements.
  • Evaluate the effectiveness of Risk Management for Compliance and Product (ISO 14971)
  • Develop appropriate Acceptability Criteria for Product and Compliance Risk Management
  • Discriminate between the expectations of Medical Devices, Pharmaceuticals, and Combination Products
  • Implement new or revised tools for improving Risk Management outcomes, both audit and field performance


Who will Benefit:

Risk Management is often a shared responsibility between multiple functions in an organization. Risk Managers may be defined by Job Title, or simply by operational function. Quality Managers will benefit greatly from this course due to their role in defining and defending the compliance aspects of these activities. R&D and Engineering will benefit due to their responsibility as Product Stewards. These functions must understand the implications of their actions with respect to overall product residual risk. Other functions include:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production managers
  • Manufacturing engineers

Use coupon code NB5SQH8N and get 10% off on registration.

Contact the event managers listed below for more information about how you can participate at the Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products: One and a Half Day In-Person Seminar.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Conference/Event Dates: 10/06/2016 - 10/07/2016
Conference/Event Hours: 8:30 AM - 12:00 PM
Classification: B2B
Primary Industry: Medical
Other Industries: Manufacturing, Medical
Estimated Attendance: 30
Cost to Attend: One Registration: $1799
Audience: Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Production managers
Manufacturing engineers
Production engineers
Venue: Venue TBD
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
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  Water: n/a
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  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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