Applying Risk Management Concepts
Throughout Your QMS
founder and CEO of QA Consulting, Inc.
Risk management is an essential component throughout the development and life cycle of both products and services. Utilizing the ISO 13485:2016 Medical devices-Quality management systems–Requirements for regulatory purposes and ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices, this presentation will focus on how risk is incorporated during design, verification, supply chain (outsourcing), and validation (design and software) as well as production and post-production phases. The presentation will include examples of risk management utilization in CAPA analysis and Complaint handling.
Regardless of the product. Risk management entails identification of hazards associated with the devices, estimation of severity of the failure and likelihood of occurrence of failure to determine the associated risks. Control measures will be discussed to obtain effective results. The goal is no harm to patients, users or the environment.
Brief case studies, will be presented to differentiate changes in the application of ISO 13485:2016 and ISO 9001:2015 standards as well transition to ISO 13485:2016. Ideas for best practices will be provided to help develop or improve the performance of your current risk management program.
Anne Holland combines more than 25 years of biomedical engineering with business acumen as founder and CEO of QA Consulting, Inc. Under her guidance, QA Consulting has grown from a local Austin-based firm, founded in 2000, to one of the leading HUB and WBENC-certified medical device consulting firms with clients throughout the nation. She is an expert in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance for Class I, II, and III medical devices.
Anne’s expertise has been sought by medical device manufacturers, from startups to Fortune 500, to develop and implement compliant solutions that meet their quality and regulatory needs. She has been called as an expert witness on medical devices and regulatory compliance. Anne has conducted over 100 supply chain and internal audits. Clients rely on her thorough knowledge of good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory remediation. She facilitates and responds to FDA and ISO 13485 Notified Body audits for manufacturers.
Anne gained much of her knowledge of quality assurance and manufacturing operations during 15 years of working in the field. Prior to beginning her consulting business, she worked for Sulzer Carbomedics in Austin, TX; Ohmeda Monitoring in Louisville, CO; Cobe BCT, Inc., in Lakewood, CO; Fischer Imaging in Broomfield, CO; and LA BAC Medical Systems in Englewood, CO. She holds a B.S. in Biomedical Engineering from Vanderbilt University in Nashville, TN, and an MBA from the University of Colorado in Denver, CO.
Anne holds certifications as an ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Manager (CQM), RABQSA Quality System Lead Auditor, and Society of Quality Assurance Registered Quality Assurance Professional in Good Laboratory Practice.
Austin Community College (ACC) Highland Business Center (HBC)
5930 Middle Fiskville Road
Austin, Texas 78752
Wednesday / May 10th
- 6:00 – 6:30 PM – Networking Time
- 6:30 – 6:45 PM – Announcements
- 6:45 – 7:45 PM – Talk
- 7:45 – 8:00 PM – Door Prizes
Registration / Cost:
Cost will be $10 per person to cover meeting expenses.
For questions contact our Arrangements Chair (David Estes): firstname.lastname@example.org
0.3 RUs shall be given for participating in this event.