Agenda

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Monday, March 11, 2019

TimeEventLocation
5:00-7:00 p.m.RegistrationConference Registration Desk
6:00-8:00 p.m.Networking ReceptionHill Atrium

Tuesday, March 12, 2019

TimeEventLocation/Speaker
7:00-8:30 a.m.Breakfast BuffetMagnolia Room
7:30-8:30 a.m.Late RegistrationConference Registration Desk
MORNING SESSION - Mahler Auditorium
8:30-8:45 a.m.Welcome and OrientationMichael Bartlett, University of Georgia
8:45-9:30 a.m.Update from the Office of Regulatory AffairsAlonza Cruse, FDA
9:30-9:45 a.m.Q&A Panel
9:45-10:15 a.m.Networking BreakHill Atrium
10:15-11:00 a.m.CybersecurityAnil Sawant, Merck
11:00-11:45 a.m.Compliance Trends and Issues for the Generic IndustryDan Barretto, Teva
11:45 a.m. - 12:00 p.m.Q&A Panel
12:00-1:00 p.m.Networking LunchMagnolia Room
AFTERNOON SESSION - Mahler Auditorium
1:00-1:45 p.m.What Practical Impact Will Brexit Have? A view from pharma companiesTor Gråberg, AstraZeneca
1:45-2:30 p.m.Impact of BrexitTBA, MHRA
2:30-2:45 p.m.Q&A Panel
2:45-3:15 p.m.Networking BreakHill Atrium
3:15-4:00 p.m.Quality Metrics and Operational Excellence: Bringing together what belongs together — Insights from a Decade of ResearchThomas Friedli, University of St. Gallen
4:00-4:45 p.m.Controlling Human Error in the Manufacturing FloorGinette Collazo, Human Error Solutions
4:45-5:00 p.m.Q&A Panel
6:30-8:30 p.m.Dinner
TBA
Magnolia Room
TBA

Wednesday, March 13, 2019

TimeEventLocation/Speaker
7:00-8:15 a.m.Breakfast BuffetMagnolia Room
MORNING SESSION - Mahler Auditorium
8:15-9:00 a.m.Biologics Compliance TrendsRobert Sausville, FDA (Invited)
9:00-9:45 a.m.Case Studies from GMP InspectionsIleana Barreto-Pettit, FDA (Invited)
9:45-10:00 a.m.Q&A Panel
10:00-10:30 a.m.Networking BreakHill Atrium
10:30-11:15 a.m.Contract Manufacturing: Challenges Posed By Clients and International Regulatory AgenciesDoug Rufino, Patheon
11:15 a.m. - 12:00 p.m.Virtual Manufacturing ChallengesTed Wheeler, Aerie Pharmaceuticals
12:00-12:15 p.m.Q&A Panel
12:15-1:15 p.m.Networking LunchMagnolia Room
AFTERNOON SESSION - Mahler Auditorium
1:15-2:00 p.m.Complaint Handling: How Far Should You Go?Jennifer Ahearn, Engineering Systems
2:00-2:45 p.m.Medical Product CommunicationsAlan Minsk, Arnall Golden Gregory LLP
2:45-3:00 p.m.Q&A Panel
3:00-3:30 p.m.Networking BreakHill Atrium
3:30-4:15 p.m.Integration of QRM in PQS / The Future Shape of the PQSEva Urban, Celgene, PDA Quality Group
4:15-5:00 p.m.Update from PDA Task Force on Data IntegrityRon Tetzlaff, Parexel
5:00-5:15 p.m.Q&A Panel
5:15-6:45 p.m.Networking ReceptionHill Atrium
Enjoy dinner in Athens!
See our Local Recommendations for local inspiration!

Thursday, March 14, 2019

TimeEventLocation/Speaker
7:00-8:15 a.m.Breakfast BuffetMagnolia Room
MORNING SESSION - Mahler Auditorium
8:15-9:00 a.m.GMP and Compounding PharmacyPhil Crooker, FDA (Invited)
9:00-9:45 a.m.Stability ProgramsJing Capucao, Johnson & Johnson
9:45-10:00 a.m.Q&A Panel
10:00-10:30 a.m.Networking BreakHill Atrium
10:30-11:15 a.m.Canadian Drug Submissions for Products Approved in the EU and USTBA, Health Canada (Invited)
11:15 a.m. - 12:00 p.m.Ingredient Supplier QualificationMarie Mathews, FDA
12:00-12:15 p.m.Q&A Panel
12:15 p.m.Conference Adjournment
POST-CONFERENCE TUTORIAL: Room R (Second Floor)
Session Coordinator: Trina von Waldner
12:15-1:00 p.m.Luncheon for Post-Conference Tutorial ParticipantsMagnolia Room
1:00-2:30 p.m.Trend Analysis and CAPA VerificationJennifer Ahearn, Engineering Systems
2:30-2:45 p.m.Networking BreakKellogg Concourse
2:45-4:00 p.m.Trend Analysis and CAPA Verification (continued)Bob Wittorf, Merck
4:00 p.m.Post-Conference Adjournment
Continuing Education (CE) credit available through this tutorial only.