Oh what a night! Thank you to everyone who attended Tuesday’s first OWL SoCal chapter meeting of 2019! Over 40 attendees joined us at the Gavin Herbert Eye Institute at UCI to network and gather pearls of wisdom from Regulatory & Quality industry leaders Denise McEachern (STAAR Surgical), and Bob Lundberg (Presbia) on the topic: “The FDA is at your door! What’s next….”
With humor and humility based on experience, Bob and Denise shared real life examples of FDA interaction on the topic, from their combined ~75 years in the medical device industry. From unscheduled 2am inspections at manufacturing sites, to what to say and not say during an Inspection, and best practices in communications and follow up with FDA.
They answered questions on whether FDA can take pictures (Yes, and you should too, in order to document their photos!), the shift in FDA culture over the decades, and provided insight into the Inspection process and the new generation of highly educated, well trained FDA Inspectors hitting the ground today.
The event was led by OWL SoCal Committee Chair Casey Lind, COO, Presbia, and eloquently moderated by Robert Sanchez, PhD, Sr. Director of Product Development, Glaukos. Many thanks to our almost 20 Champion members who attended and OWL Board members, Abby Markward and Heather Ready. Attendees included representatives from Aerie, Acufocus, Alcon, Allergan, B+L, Glaukos, J&J Vision, McDermott and Bull Executive Search, Presbia, Prodigy (Executive) Search Group, STAAR Surgical, Targus, UCI, and several other key organizations in the OC.
Many thanks to Oakley for donating “runners world” gift bags, and to Presbia, our wine sponsor. Go OWL!