Agenda Register at:

www.convencionprma.com
SOMOS UNO | C O N V E N C I Ó N I N D U S T R I A L E S 2 0 1 8

2018 PRMA CONVENTION • Complejo Ferial de Puerto Rico, Ponce

May 29th, 2018 (8:30 am - 5:00 pm)

7:30 AM REGISTRATION PUERTO RICO

PRTEC
TECHNOECONOMIC CORRIDOR
8:30 AM Welcome And Opening Remarks
Rodrigo Masses, President PRMA / Nélida Plaza, Q&C
Committee Leader / Félix M. Negrón, MD Cluster Chairperson

8:45 AM Keynote Speaker, FDA Update Medical Devices

Program Alignment, Recalls
Blake Bevill, FDA Director OMDRHO, Division 2 Central

9:15 AM FDA MD Single Audit Program

Neil Mafnas, FDA Program Coordinator Medical Device Single
Audit Program (via Conference)

9:30 AM Contamination Control Programs for

Medical Device Manufacturers
Joe McCall, Technical Service Specialist, Steris Corporation

10:00 AM Evolution of the Quality Professional in the

Medical Devices Industry
Eileen Serrano, President ASQ Puerto Rico Chapter

10:30 AM COFFEE BREAK

11:00 AM Case for Quality Program Industry Update

Raymond Seda, Director of Quality, Medtronic

11:30 AM Case for Quality Program FDA Update

Francisco Vicenti, FDA Consumer Safety Officer
(via Conference)

12:00 PM LUNCH & SPONSORS EXHIBITION HALL VISIT

1:30 PM Risk Management Workshop

Moderated by Q&C Committee

2:30 PM COFFEE BREAK

3:00 PM 2017-2018 Medical Device Inspection Trends

José “Paco” Pedró, FDA Supervisory Consumer Safety Officer

3:15 PM Complying with Combination Products and Medical

Device Regulation and Trends
Laiza García, FDA Consumer Safety Officer

3:45 PM Human Factor Studies and Their Relevance for

Combination Product Design and Performance
Adaliz Santaliz-Cruz, FDA Consumer Safety Officer

4:15 PM Panel Discussion

All Speakers

4:50 PM Closing Remarks

5:00 PM NETWORKING ACTIVITY