Agenda

Agenda

Oct. 11
noon-1:00Registration & badge pick-up
1:00-1:05Introductory remarksPeter Bigelow • PBOA
1:05-1:40Legislative Advocacy PanelBrent Del Monte • BGR Government Affairs
Mary Beth Spencer • Thermo Fisher Scientific
Evan Knisely • Catalent Pharma Solutions
1:40-2:20Managing Supply-Demand in a More Dynamic, Post-Pandemic WorldIan Tzeng • L.E.K. Consultants
2:20-2:55ESG & SustainabilityElizabeth Millman Hardin • BCG Consulting (remote)
2:55-3:10MID-DAY BREAK
3:10-3:45The Practicality of Nitrosamine-Free (??) PharmaceuticalsAloka Srinivasan, Ph.D. • RAAHA LLC
3:45-4:20FDA: Advancing Quality Surveillance: Updates on Quality Metrics & Quality Management MaturityNandini Rakala • FDA/CDER
4:20-4:55FDA: Inspectional UpdateAlonza Cruse • FDA/ORA
4:55-5:00Closing remarksGil Roth • PBOA
5:00-6:00COCKTAIL RECEPTION
6:30-10:00OFF-SITE NETWORKING DINNER
Oct. 12
7:00-8:00BREAKFASTSponsored by CAI
8:00-8:05Introductory remarksGil Roth • PBOA
8:05-8:45Qualification and Validation of Lab and ATMP EquipmentAaron Weinstein • IPS
8:45-9:20Client-Side AuditsNigel Smart • Smart Pharma Consulting (remote)
9:20-9:55CDMOs & CybersecurityAaron Pritz • Reveal Risk (remote)
9:55-10:30Large Molecule Outsourcing TrendsEric Langer • BioPlan Associates
10:30-11:00COFFEE BREAKSponsored by Societal CDMO
11:00-11:40The Role of Fill/Finish in Pandemic ResponseJoe Hamel • ASPR
11:40-12:15Is Your Workforce A Competitive Advantage?Harry Benson • CAI
12:15-1:00LUNCH
1:00-1:35Driving Data Integrity for Quality Through the CloudAnooj Desai • Veeva
1:35-2:10FDA: CDER CGMP UpdatesTara Gooen-Bizjak, CDR • FDA
2:10-2:30PBOA Priorities: Setting the AgendaGil Roth • PBOA
2:30-2:35Closing remarksPeter Bigelow • PBOA
3:00-5:00Quarterly Meeting of PBOA Board of Trustees(closed to non-board members)

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

Agenda subject to change