TIME

min.

Discussion Topic

Speaker

7:30 - 8:30 AM

60

Registration

All

8:30 - 9:00 AM

30

Welcoming Remarks

•           PIA QAC Chairperson

•           PIA- PR President

•           FDA-SJDO Director

Irma R. Vicente

Daneris Fernández

Maridalia Torres

9:00 – 9:40 AM

40

Conference

FDA Overview on Compliance Trends; Opportunities for Domestic and Global Markets

Douglas Stearn

Assistant Director, FDA/Center for Drug Evaluation and Research/ office of Compliance

9:40 – 10:20 AM

40

ICH Quality Guidelines (Q8, 9 & 10): Implementation Challenges and Opportunities

Terry Ocheltree, PhD, R.Ph. Division Director Office of  New Drug Quality Assessment, FDA Center for Drug Evaluation and Research

10:20 – 10:35 AM

15

Morning Break

All

10:35 – 11:45 AM

50

Increasing Control in the Supply Chain of Incoming Materials With a QbD Approach

José E. Meléndez, Drug Specialist CSO, FDA/ORA San Juan District Office

11:45 – 1:00 PM

75

Lunch

All

1:00 – 2:00 PM

60

Industry Case Study: TBA in the Supply Chain

Verónica  Cruz , PhD    Vice President Quality Assurance  McNeill Consumer Healthcare

2:00 – 2:40 PM

40

Analysis and Testing Strategies and Technologies to Improve the Detection of Pharmaceutical Adulterants

Michael Hunnicut, PhD, Assistant VP, Pfizer Global Quality Operations, Scientific and Laboratory Services

2:40 – 3:30PM

50

FDA Sites, Strategic Planning and Other Laboratory Initiatives

Elizabeth A. Kage, Deputy Director, Southeast Regional Laboratory

3:30-4:30 PM

60

Industry/ FDA Panel Discussion

PIA QAC Vice-Chairperson  Nora Albizu/Gloria Martínez

4:30– 5:00 PM

30

Closing Remarks

Irma R.Vicente-PIA

5:00 – 6:00 PM

60

Cocktail

All