Quality Time With Oliver: Guest David DiVaccaro - Part 1

Risk assessment for sterile barrier packaging requires more than checking boxes against a standard. FMEA can help teams anticipate how packaging failures may occur, how severe the impact could be, and where controls are needed to protect device safety and compliance. But even a structured process can fall short when teams rely too heavily on templates, overlook historical failure data, or miss the practical lessons gained across similar packaging projects.

Oliver Stauffer and David DiVaccaro break down how ISO 11607 supports a strong foundation for risk management while emphasizing the value of hands-on industry experience. From identifying weak points early to avoiding common evaluation mistakes, their conversation offers useful guidance for building more informed, defensible packaging risk strategies. Gain practical insight into FMEA, sterile barrier packaging quality, and compliance.