August 19 2020 WEBINAR

August 19, 2020
6:00 PM to 7:00 PM
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Please register here:

https://www.eventbrite.com/e/capa-insights-lessons-learned-from-fda-inspections-tickets-113977983216

If you have any problems to register please contact [email protected] or call 714-613-3257

Topic:     CAPA Insights: Lessons Learned from FDA Inspections                      
Over the past ten years, the US FDA has given increasing scrutiny to how medical device manufacturers manage their CAPA programs.  This presentation will go over common difficulties and recommend practical approaches to the identification of actions needed, the analysis and collection of data, and an emphasis on the verification of effectiveness.

Our Speaker: TONI LUCERO-AURELIO

 

Toni Lucero-Aurelio attended the Transportation Design program at Art Center College of Design in Pasadena, CA.  She studied Global Enterprise Management at Ecole Superieure de Commerce de Rouen and at University of Oxford - en route to her Masters in Business Administration from Pepperdine University.

Toni has 15 years experience in medical devices ranging from endovascular and drug-eluding stents, respiratory diagnostics and ventilators, to Class III active implantable devices, as her background progressed from R&D Engineering to Quality and Regulatory Affairs.  In her current role as Director Regulatory Affairs and Quality System Compliance at Applied Medical in Rancho Santa Margarita, she oversees the Internal Audit and CAPA programs.

She is a member of Regulatory Affairs Professionals Society, and is ASQ Certified Reliability Engineer, ASQ Certified Quality Engineer and ASQ Certified Six Sigma Black Belt.

Connect with Toni through email: [email protected] or LinkedIn: linkedin.com/in/tonilucero

For further information on the meeting or interested in presenting at the monthly meeting please contact Subbu Shanmugham by email at [email protected] or at 714-613-3257.