WEBINAR OVERVIEW

Accurate and thorough investigations are critical in an FDA regulated environment. The FDA considers the integrity of laboratory testing documentation records to be paramount importance during drug manufacturing. As a manufacturer, you must ensure that your laboratory-based investigation of failures (OOS results and confirmed OOS results) is carried out without compromising product quality or current authority expectations.

For quality professionals, the challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds. This session provides a process to overcome that challenge, where attendees will learn to effectively expedite and document OOS and non-conformance investigations to increase compliance in their organizations.

Key learning points include:

I. Creating SOPs for FDA compliance
II. Best practices for data collection
III. Appropriate resolutions

ABOUT THE SPEAKER

Edward Hazelrig has over 25 years of quality management experience in the life science industry. As the Supplier Quality Manager for Boston Scientific, Edward was responsible for Supplier Quality Engineering, training of Production and Quality Engineering personnel, Standard Operation Procedure development, and Quality System development for new processes. He has specific experience in the development of protocols for new product lines and vendor processes, as well as the approval of procedures and requirements for the handling of new equipment. Mr. Hazelrig is well versed in complaint handling, investigations coaching, writing and updating quality system procedures, managing process improvement teams and budgeting.