Conference Description:

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 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 Objectives:
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
Production engineers
Design engineers and managers
Process owners
Quality engineers
Quality auditors
Document control specialists
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar