Portland State Business Accelerator

This course provides a structured guide to the process of performing an effective Failure Mode and Effects Analysis for Manufacturing Processes (PFMEA). PFMEA can be performed during development of manufacturing processes to minimize scrap and rework and to minimize the risk of quality “escapes”. It is also a highly effective technique to use in planning […]

The key to improving process performance is the ability to understand, control and reduce variation. In this workshop, participants will learn how the monitoring and analysis tools of SPC can be used to achieve that goal. Going beyond the mere mechanics of SPC, this workshop will also guide participants through the steps needed to define […]

This course introduces students to the foundations of successful project management, especially in a technology environment. Students will learn key project management concepts, then immediately apply them in a hands-on team simulation. This course approaches project management from the standpoint of managing a single, stand-alone project that is small to medium in size. It takes […]

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 course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in […]

Many organizations, such as FDA, ISO, OSHA, and EPA, can conduct audits or inspections in a biotech company. Most people view these events as scary, but there are ways to make them less difficult. The first method is compliance with the applicable rules. After that, preparation is the key. We will focus on these preparatory […]

Quality 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 […]

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 […]

Overview: Quality 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 […]

Overview: 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 […]