Quality Assurance 80-hour Certificate

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.

Click the Flyer for Class Descriptions:

Training Schedule:

ISO13485:2016 Internal Auditor Training – Dec. 5 – 6, 8:30 a.m. – 5 p.m.
Root Cause Analysis and Corrective Action – May 5, 8:30 a.m. – 5 p.m.
Overview of FDA – May 6, 1 p.m. – 5 p.m.
Quality Systems Overview – May 7, 1 p.m. – 5 p.m.
Preparing for Regulatory Inspections – May 8, 1 p.m. – 5 p.m.

Current Good Manufacturing Practices (cGMP) (One-Day class, TBA)
Data Integrity and Good Documentation Practices (Half-Day class, TBA)
Change Management (Half-Day class, TBA)
Managing Deviations (Half-Day class, TBA)
Risk-Based Approach to Manufacturing: ICH Q8, Q9, ISO14971 (One-Day class, TBA)
Customer Complaints and Recalls (One-Day class, TBA)
Design Controls (One-Day class, TBA)