Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products (COM)
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.
If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
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?
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
Design engineers and managers
Document control specialists
Day 01(8:30 AM – 4:30 PM)
Registration Process: 8:30 AM
Introduction to Risk Management
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
Review of Guidance Documents for Risk Management Considerations
Integrating Key Elements of Both Pharmaceuticals and Devices
Enterprise Risk Management and ISO 31000
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 02(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
Audits – Internal and External
Documentation is key to a successful program
Risk Management and Operational Excellence
The Concept of Positive Risk as Opportunity
Benchmarking for the Future
Discussion of Future Trends in Risk Management
Turning Risk Management into a Strategic Advantage
Q & A
Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards
Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee f
Please contact the event manager Marilyn below for the following:
– Discounts for registering 5 or more participants.
– If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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at Minneapolis, Minnesota, United States
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