Agenda

Agenda

The 2020 edition of the PBOA Meeting & Conference will be held virtually from December 7 to December 16. More speakers and sessions will be added in the days ahead, so please check back. Here is the conference agenda:

Monday, Dec. 7
Introductory remarksPeter Bigelow • PBOA
noonVirtual Inspections & CDMOsCynthia Schnedar and Kalah Auchincloss • GreenLeaf Health
Tuesday, Dec. 8
11:00 a.m.Financing Projects with DFCDavid Vidal and Thuan Nguyen • US International Development Finance Corp. (DFC)
1:00 p.m.State and Local Distribution RegulationsSumeet Singh • Five Rivers Rx
Wednesday, Dec. 9
11:00 a.m.Annex 1: European GMPs for Sterile ProductsPanel led by Jörg Zimmermann • Vetter Pharma
Christa Meyers • CRB
Vince Cebular •IPS
Alice Redmond • CAI
Walid El Azab • Steris Solutions
1:00 p.m.State of the CDMO SectorIan Tzeng • L.E.K. Consulting
David Windley • Jefferies LLC
Jim Miller • PharmSource (ret'd.)
Daniel Cohen • RBC
Monday, Dec. 14
11:00 a.m.FDA's Quality Management Maturity MetricsLyle Canida • FDA
1:00 p.m.State of Biologics Outsourcing & Contract ManufacturingEric Langer • BioPlan Associates
Tuesday, Dec. 15
11:00 a.m.FDA Inspectional UpdateAlonza Cruse • FDA
1:00 p.m.Accelerating the Transition from Paper to Digital in High Volume ManufacturingAdam Sybrowsky • MasterControl
3:00 p.m.Post-Approval Changes and One Quality VoiceAnders Vinther • Intarcia Therapeutics
Wednesday, Dec. 16
11:00 a.m.CDMOs and Virtual Customer Audits PanelPatrick Butler • Lifecore Biomedical
Darwin Richardson • Aji Biopharma Services
Dawn Wofford • Cytovance Biologics
Audrey Butler • Adare Pharma Solutions
Monica Commerford • Thermo Fisher Scientific
1:00 p.m.State of the PBOA • Strategic Plan RolloutGil Roth • PBOA

Visit our Speakers page for bios of our speakers and panelists.

Agenda subject to change