All industries regulated by FDA are expected to have robust product designs, well-controlled manufacturing processes, effective quality control measures, and a comprehensive quality system to identify potential problems, investigate them, and take appropriate actions. Product recalls are an unwelcome, but important, part of the spectrum of corrective and preventive actions that industry uses.

In this audio conference, the speaker reviews recall regulations, initiation and conduct of recalls, and provides tactical recommendations, focusing on medical devices, but with broader applicability. The presentation serves as an introduction for those new to the topic, and also as a refresher for those already familiar with recalls.

This audio conference covers:

• How the need for recall is determined
• The logistics of initiating and conducting a recall
• The role of FDA
• How to interact successfully with the Agency

About the speaker:

During his 24 years in the medical device industry, Bruce MacFarlane, PhD has held executive and senior managerial positions in regulatory affairs and quality systems with Bio-Vascular (now Synovis), Vital Images, DiaSorin, and Hypoguard (now ARKRAY USA). In 2006 he joined Alquest, Inc. as a Principal Project Manager. Alquest is a CRO that also provides full regulatory and quality system support to its clients. Bruce's regulatory experience includes writing over fifty 510(k) submissions for products such as implantables, electrotherapy devices, surgical instruments, medical imaging software, and in vitro diagnostic instruments and reagents. He has obtained ISO 9001/13485 certification at 2 companies.

In his role as Vice President of Regulatory Affairs and Quality Systems at previous companies, he gained practical experience in the initiation and conduct of product recalls. Dr. MacFarlane earned his BA from Yale University; his doctorate from the University of Pennsylvania; and did post-graduate work at The Johns Hopkins University.

Who should attend?

• Regulatory Affairs - Directors, Managers & Associates
• Quality Systems - Directors & Managers
• Engineering - Directors & Managers
• Clinical Affairs - Directors, Managers & Associates
• R&D - Directors & Managers
• Corporate Counsel

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.