Agenda
Oct. 11 | ||
noon-1:00 | Registration & badge pick-up | |
1:00-1:05 | Introductory remarks | Peter Bigelow • PBOA |
1:05-1:40 | Legislative Advocacy Panel | Brent Del Monte • BGR Government Affairs Mary Beth Spencer • Thermo Fisher Scientific Evan Knisely • Catalent Pharma Solutions |
1:40-2:20 | Managing Supply-Demand in a More Dynamic, Post-Pandemic World | Ian Tzeng • L.E.K. Consultants |
2:20-2:55 | ESG & Sustainability | Elizabeth Millman Hardin • BCG Consulting (remote) |
2:55-3:10 | MID-DAY BREAK | |
3:10-3:45 | The Practicality of Nitrosamine-Free (??) Pharmaceuticals | Aloka Srinivasan, Ph.D. • RAAHA LLC |
3:45-4:20 | FDA: Advancing Quality Surveillance: Updates on Quality Metrics & Quality Management Maturity | Nandini Rakala • FDA/CDER |
4:20-4:55 | FDA: Inspectional Update | Alonza Cruse • FDA/ORA |
4:55-5:00 | Closing remarks | Gil Roth • PBOA |
5:00-6:00 | COCKTAIL RECEPTION | |
6:30-10:00 | OFF-SITE NETWORKING DINNER | |
Oct. 12 | ||
7:00-8:00 | BREAKFAST | Sponsored by CAI |
8:00-8:05 | Introductory remarks | Gil Roth • PBOA |
8:05-8:45 | Qualification and Validation of Lab and ATMP Equipment | Aaron Weinstein • IPS |
8:45-9:20 | Client-Side Audits | Nigel Smart • Smart Pharma Consulting (remote) |
9:20-9:55 | CDMOs & Cybersecurity | Aaron Pritz • Reveal Risk (remote) |
9:55-10:30 | Large Molecule Outsourcing Trends | Eric Langer • BioPlan Associates |
10:30-11:00 | COFFEE BREAK | Sponsored by Societal CDMO |
11:00-11:40 | The Role of Fill/Finish in Pandemic Response | Joe Hamel • ASPR |
11:40-12:15 | Is Your Workforce A Competitive Advantage? | Harry Benson • CAI |
12:15-1:00 | LUNCH | |
1:00-1:35 | Driving Data Integrity for Quality Through the Cloud | Anooj Desai • Veeva |
1:35-2:10 | FDA: CDER CGMP Updates | Tara Gooen-Bizjak, CDR • FDA |
2:10-2:30 | PBOA Priorities: Setting the Agenda | Gil Roth • PBOA |
2:30-2:35 | Closing remarks | Peter Bigelow • PBOA |
3:00-5:00 | Quarterly 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