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Who should attend Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
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
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Seminar Summary:

Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. (see full course description)

 
 
 

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Training Course Syllabus:


Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products

Course 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 System 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.

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 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

Course Outline:

DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM

Introduction to Risk Management
Pharmaceuticals
Combination Products
Medical Devices
Common Elements
What is the Difference Between Risk Management and Risk Science and Why Is It Important?
Risk Science Supports Risk Management
The Confusion and the consequences
Pharmaceutical Risk Management
Discussion of Current Expectations
Integrating into Quality System
Techniques to tie the Islands of Excellence Together
Medical Device Risk Management
Discussion of Current Expectations
AAMI White Paper and Z Annexes to ISO 14971
Expanding Beyond Just FMEA
Combination Products
Review of Guidance Documents for Risk Management Considerations
Integrating Key Elements of Both Pharmaceuticals and Devices
Enterprise Risk Management and ISO 31000
International Standard
ISO 90001 has changed the Paradigm
The New Concept of “Risk-Based Thinking”
What is changing for all industry?
What Is Compliance Risk Management?
Compliance Risk Management is the bridge to ISO 90001
Compliance Risk Management has a different objective
What are we going to have to do differently and when?
Do I Have to Implement Compliance Risk Management and When?
Discussion of Pro’s and Con’s
Methods for Documentation
Relationship to existing Quality Risk Management
How to Prepare for Compliance Risk Management
Establishing Process Owner
Establishing Objective Acceptability Criteria
Integrating into Quality System

DAY TWO (8:30 AM – 12:00 PM)

Acceptability Criteria – Do’s and Dont’s
Product Risk Management
Compliance Risk Management
The Master Document
Advantages of a Trace Matrix Approach
Segmentation of the Risk Management File
Integration Considerations
Audits – Internal and External
Documentation is key to a successful program
Risk Management and Operational Excellence
The Concept of Positive Risk as Opportunity
Cost Reductions
Documentation Justifications
Benchmarking for the Future
Discussion of Future Trends in Risk Management
Turning Risk Management into a Strategic Advantage
Q & A

Seminar Summary:

Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. (see full course description)

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