April 2019 OWL SoCal Connect


 OWL SoCal Connect

Thank you to our sponsor, panelists, and attendees for making the first SoCal Connect Event such a great success! 

We look forward to welcoming you all to our next chapter event.

 


 

“FDA IS AT YOUR DOOR! WHAT’S NEXT?”

SUCCESS STRATEGIES BASED ON REAL WORLD EXPERIENCE, AND WHAT YOU CAN DO NOW, WORKING WITH THE FDA.

 

OUR PANELISTS FOR THIS DISCUSSION:

 

BOB LUNDBERG 

Sr. VP Regulatory & Quality Systems

Presbia 

 

 

Bio
Robert “Bob” Lundberg is Senior Vice President Regulatory/Quality at PresbiBio “Presbia”, LLC. Bob is responsible for global regulatory and quality strategies.

Bob has over thirty years of experience in the medical device industry, including engineering, quality, clinical, and regulatory affairs. Before joining Presbia, Bob worked with Cordis, a Cardinal Health Company; Alcon; Fresenius Kabi; eV3 Neurovascular (now Medtronic); and other innovative industry companies.

Bob has been recognized as an innovative and collaborative leader helping companies implement engineering, quality and regulatory practices that benefits patients, mentors employees and achieves shareholder goals. He is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). He works closely with and believes in a collaborative partnership with FDA and other global health authorities.

 

 

DENISE McEACHERN

Global Head Regulatory Affairs

STAAR Surgical Company

 

 

 

Bio
Denise McEachern is a member of the STAAR Surgical Executive Management Team. STAAR Surgical has undergone unprecedented growth in the highly competitive refractive vision correction market, with STAAR Net sales for FY 2018, up 37% compared to FY 2017.

Denise is a recognized global regulatory expert with over thirty-five years of experience in the medical device, diagnostics and pharmaceutical industry. She has served on Executive Management Teams as Global Head of Regulatory and Quality Assurance for STAAR Surgical, Vice President of Regulatory Affairs for Bausch & Lomb, Vice President of Quality, Regulatory and Development Affairs for LifeScan, Johnson & Johnson, and Director of Regulatory & Clinical Affairs for Vistakon, Johnson & Johnson.

Her background in QA, QC laboratories, Manufacturing, R&D, Clinical, Compliance, and Regulatory Affairs provide diverse knowledge and skills used in the development and implementation of strategic solutions. She has created both new and improved Quality Systems and processes throughout her career. Through insight, motivation, and interdependent partnering, she has led programs to improve the quality system and resolve compliance issues resulting in sustainable compliant quality systems worldwide.

Denise has a history of leading successful remediation efforts. She led the LifeScan remediation program in the early 2000’s leading to the lifting of the “Special Conditions of Probation” with the Department of Justice. Most recently she led the STAAR Surgical team through the resolution of the Warning letter issued in May 2014. Denise joined STAAR Surgical in July 2014, and led the “comprehensive remediation program that not only addressed the issues raised by the FDA in the 2014 Warning Letter, but included the assessment, remediation and upgrade of all aspects of STAAR’s quality systems to assure compliance with Quality System Regulations (QSR).” STAAR received the FDA Warning Letter closeout notice in June 2018.

Denise is RAC certified, and was inducted as a Fellow in the Regulatory Affairs Professional Society in 2013. She earned an Executive Juris Doctor with a concentration in Health Law from Concord Law School in 2011, and a B.S. in Biology with a minor in Chemistry from Washington College in 1980.


We are thankful to Presbia, our Wine Sponsor for this SoCal Connect event.