Events
Upcoming Events
20 February 2025 | 12:00 - 1:00 PM EST
MARSQA February Lunch and Learn Webinar: Risk-Based Approach vs. Risk Management
Presented by: Steve Gompertz
Risk-Based Approach and Risk Management are often incorrectly thought of and applied as synonyms when instead they are intended to be different but complementary methods with a common goal of identifying and controlling risk. For years, regulations and standards have been increasing their focus on the application of a Risk-Based Approach (RBA) to quality management. Unfortunately, many people have confused that concept with the more formal Risk Management (RM) process when they are two related but different concepts. At its simplest, RM is a subset of RBA, for use when formal risk analysis, evaluation, and control are necessary. In most situations, however, an awareness of the risks and how to mitigate them is all that’s required, i.e. – applying risk-based thinking; AKA a risk-based approach. The presentation will first establish a clear understanding of the basic concepts of Risk, Risk-Based Approach, and Risk Management, along with when to apply each within the Quality Management System. This presentation will be of interest to Quality Engineers and Quality System Managers, Directors, and Vice Presidents who want to learn how to make risk management much less painful.
- Presentation Outline:
- What is Risk?
- Risk-Based Approach vs. Risk Management
- Identifying when each is required according to the standards and regulations
- How can risk-based approach by demonstrated?
- Learning Objectives:
- Understand the differences and relationship between Risk-Based Approach and Risk Management
- Understand when to apply each
- Learn how to demonstrate how your QMS is applying a Risk-Based Approach
Upon completion of this session, attendees will understand the following:
MARSQA CVC Activities
MARSQA Members, join us for these upcoming CVC activities! The MARSQA CVC has some exciting activities planned this year. For more details, or to receive meeting access information, reach out to Denise Botto at denise.botto@syneoshealth.com.
- CVC Monthly Meeting: First Tuesday of the month from 9:00-10:00 AM ET
- Reach out to Denise Botto for meeting access information.
Recent Events
- 24 October 2024 MARSQA Membership Meeting
- 17 October 2024 MARSQA October Lunch and Learn Webinar Series
- 16 September 2024 MARSQA and RQA Regional Forum: Explore AI, Data Integrity, and Digital Quality
- 13 June 2024 MARSQA June Lunch and Learn Webinar Series
- 23 May 2024 MARSQA May Lunch and Learn Webinar Series
- 14 May 2024 MARSQA CVC Roundtable Event
- 17 October 2023 MARSQA CVC Roundtable Event
- 14 September 2023 MARSQA Membership Meeting
- 27 July 2023
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FDA BIMO Sponsor Compliance Program Update - Nicole Victoria - 9 February 2023
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Cyber Security Essentials - Jason Kentner
The Selective Deployment of AI in Healthcare - Markus Trengove
CLIA-Accredited Labs: History and Importance – Where Are We Now? - Erica Falcon
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Stay tuned for future event information.