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December 2019
The BioPro Quality Assurance Certificate is a comprehensive 80-hour training series. With a formal steering committee of human resources representatives and industry experts, Oregon Bio selects courses and instructors that will have the most value to industry and their workforce development needs. From high level overview courses including Overview of FDA Requirements and Quality Systems to technically detailed classes including Root Cause Analysis and Internal Auditor Training, this series is built to train current and future Quality Assurance professionals. Certificates offer a substantial saving compared to taking the classes individually.
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To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This new course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.
Find out moreMay 2020
Two key goals of a quality management system are to find the root causes of actual and/or potential problems in order to develop and implement permanent solutions that are accepted, efficient, and effective. This 1-day workshop will show how to use root cause analysis tools and methods to find the underlying causes of problems that impact an organizations operations and profitability. You will also learn the methodology to address corrective actions. This workshop is perfect for the novice or for those desiring an invigorating refresher.
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The FDA has more power to affect regulated companies than almost any other organization, yet many people don’t understand it. Many others ignore it as much as possible. But the FDA affects the job of every person in a medical device or drug company. This course is designed to provide participants with insight into what the regulations are, why they are there, where they fit together, when they apply, and how to interpret them. We will not just discuss Quality Systems and Good Manufacturing Practices, but also submissions, registration, clinical trials, recalls, and adverse event reporting. Each participant will develop a better understanding of the environment in which their company exists and how they can help their company thrive.
Find out moreQuality Systems (QS) are sometimes viewed as a necessary evil or belonging only to production and QA personnel. However, effective QS can help a business not only comply, but excel. This course focuses on medical device companies and how to create, implement, and improve QS that match your company. Both FDA QS and ISO QS will be discussed. We will also cover: how different departments are impacted by QS, the biggest pitfalls in establishing and maintaining QS, and how to critically evaluate your QS. There will be group exercises and lots of interaction among participants to provide multiple options. In QS, it is definitely true that one size does not fit all!
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