Portland State Business Accelerator – Mt. Hood Room

Overview of FDA Requirements for Regulated Industries

Portland State Business Accelerator - Mt. Hood Room 2828 S. Corbett Ave., Portland, OR, United States

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.

Get Tickets $200.00 – $250.00

Quality Systems Overview, Implementation and Improvement

Portland State Business Accelerator - Mt. Hood Room 2828 S. Corbett Ave., Portland, OR, United States

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 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!

Get Tickets $200.00 – $250.00

Preparing for Regulatory Inspections

Portland State Business Accelerator - Mt. Hood Room 2828 S. Corbett Ave., Portland, OR, United States

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 techniques, for example, using internal auditing as a tool, developing an inspection procedure, educating employees, and conducting mock inspections. Participants will roll-play being auditors and auditees.

Get Tickets $200.00 – $250.00

Statistical Process Control

Portland State Business Accelerator - Mt. Hood Room 2828 S. Corbett Ave., Portland, OR, United States

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 a process and determine proper measurement techniques so that the right control chart is used in the right place at the right time.

Get Tickets $625.00 – $775.00