Agenda

  • Monday, March 12, 2018

    TIME TOPIC
    5:00 – 7:00p.m. Registration  Conference Registration Desk
    6:00 – 8:00p.m. Networking Reception  Hill Atrium
  • Tuesday, March 13, 2018

    TIME TOPIC SPEAKER/LOCATION
    7:00 – 8:30a.m. Breakfast Buffet  Magnolia Room
    7:30 – 8:30a.m. Late Registration  Registration Desk
    MORNING SESSION – Mahler Auditorium
    8:30 – 8:45a.m. Welcome and Orientation  Michael Bartlett, University of Georgia
    8:45 – 9:30a.m. Update from the Office of Regulatory Affairs  Alonza Cruse, FDA
    9:30 – 9:45a.m. Q&A
    9:45 – 10:15a.m. Networking Break  Hill Atrium
    10:15 – 11:00a.m. Championing a Culture of Quality  Ranjana Pathak, Cipla
    11:00 – 11:45a.m. Quality Culture:  Bold Leadership not Optional  Crystal Mersh, QEP
    11:45 – 12:00p.m. Q&A Panel
    12:00 – 1:00p.m. Networking Lunch  Magnolia Room
    AFTERNOON SESSION – Mahler Auditorium
    1:00 – 1:45p.m.  Update from the Office of Manufacturing Quality  Maan Abduldayem, FDA
    1:45 – 2:30p.m  EU Guidance Update  Tracy Moore, MHRA
    2:30 – 2:45p.m.  Q&A Panel
    2:45 – 3:15p.m. Networking Break  Hill Atrium
    3:15 – 4:00p.m. Combination Products: Current Regulatory Landscape T.G. Venkateshwaran, Merck
    4:00 – 4:45p.m. Critical Thinking and Auditing William Mestrandrea, Pfizer
    4:45 – 5:00p.m. Q&A Panel
    6:30– 8:30p.m Regenerative Medicine: The Future is Here

    Dinner

    Steven Stice, UGA

    Magnolia Ballroom

  • Wednesday, March 14, 2018

    TIME TOPIC SPEAKER/LOCATION
    7:00 – 8:15a.m. Breakfast Buffet  Magnolia Room
    MORNING SESSION – Mahler Auditorium
    8:15 – 9:00a.m. Update on the Office of Pharmaceutical Quality  Ashley Boam, FDA
    9:00 – 9:45a.m.  Update from the Office of the Ombudsman  Laurie Lenkel, FDA
    9:45 – 10:00a.m. Q&A Panel
    10:00 – 10:30a.m. Networking Break  Hill Atrium
    10:30 – 11:15a.m.  International Inspections Lessons Learned  Tor Graberg, AstraZeneca
    11:15 – 12:00p.m. Leadership to Improve Human Performance  Steve Greer, P&G
    12:00 – 12:15p.m. Q&A Panel
    12:15 – 1:15p.m. Networking Lunch Magnolia Room
    AFTERNOON SESSION – Mahler Auditorium
    1:15 – 2:00p.m. Case Studies – Past Data Integrity Process Control Considerations  Anthony Lostracco, Health Canada
    2:00 – 2:45p.m.  Current GMP Trends in Brazil  Ihatanderson Alves da Silva, Anvisa
    2:45 – 3:00p.m.  Q&A
    3:00 – 3:30p.m. Networking Break  Hill Atrium
    3:30 – 4:15p.m.  GMP in Continuous Manufacturing  Eric Jayjock, Patheon
    4:15 – 5:00p.m.  Emerging Manufacturing Technologies  Thomas O’Connor, FDA
    5:00 – 5:15p.m. Q&A
    5:15 – 6:45p.m. Networking Reception  Hill Atrium
    Enjoy Dinner in Athens!
  • Thursday, March 15, 2018

    TIME TOPIC SPEAKER
    7:00 – 8:15a.m. Breakfast Buffet  Magnolia Room
    MORNING SESSION – Mahler Auditorium
    8:15 – 9:00a.m.  Change Control and Impact on Quality  Jennifer Ahearn, Pharma. & Med. Dev. Reg. Group
    9:00 – 9:45a.m.  Virtual Manufacturing: A Quality Perspective  Robert Wittorf, Merck
    9:45 – 10:00a.m.  Q&A Panel
    10:00 – 10:30a.m.  Networking Break  Hill Atrium
    10:30 – 11:15a.m.  Top 10 GMP Violations  Marie Mathews, FDA
    11:15 – 12:00p.m.  Complaint Handling and the Impact of Social Media  Alan Minsk, Arnall, Gregory & Golden
    12:00 – 12:15p.m.  Q&A Panel
    12:15p.m.  Conference Adjournment
    POST CONFERENCE TUTORIAL – Room R (Second Floor) Session Coordinator: Trina von Waldner
    12:15 – 1:00p.m.  Luncheon for Post Conference Tutorial Participants  Magnolia Room
    1:00 – 2:30p.m.  Internal Data Integrity Auditing  Jennifer Ahearn, Pharma & Med. Dev. Reg. Group
    2:30 – 2:45p.m.  Networking Break  Kellogg Concourse
    2:45 – 4:00p.m.  Internal Data Integrity Auditing (Continued)  Dan Spankie , Pharma & Med. Dev. Reg. Group
    4:00p.m.  Adjourn