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