Conference Schedule

Tuesday, 11 June
08:20 - 08:30	Welcome, Opening Remarks Nancy Berg, President and CEO, ISPE, USA
08:30 - 09:30	Quality Risk Management Jaspreet Gill, VP, Global Quality-Compl., Baxter Healthcare Corp, USA
09:30 - 10:30	Quality Pays for Itself Andrew Skibo, Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca, USA
10:30 - 11:00	Networking Break
11:00 - 13:00	Breakout Session - Basic PAI Readiness Success and Advent of Breakthrough Therapies Joanne Barrick, Advisor, Global Validatn, Eli Lilly & Co, USA Process Validation PQLI Efforts to Provide Practical Implementation Methodology - focus on Stage 2 to 3 Leading from Aproval to Commercialization David Doleski, Director, Division of DGMPA, CDER / FDA Office of Compliance, USA Challenges to Inspection Readiness Earl Dye, Director, Genentech Inc, USA Breakthrough Therapy and Challenges for Ensuring Commercial Readiness
11:00 - 13:00	Breakout Session - Quality Management of CMO's Carol Bye, VP, Pharm Sci, Quality Ops, Pfizer Worldwide Research and Development, United Kingdom Application of Risk Management in the Oversight of Contract Manufacturers for Supply of Product to Clinical Trials Zena Kaufman, Sr. VP Global Quality, Hospira, USA Contract Manufacturing - A Lifecycle Approach from the perspective of the Contract Manufacturer
11:00 - 13:00	Breakout Session - Leadership in Pharma Quality Management Monica Caphart, Supervisory Consumer Safety Officer, DMPTPO/OMPTO/OO/ORA, USA Victor Gaines, Chemist, CDER/FDA, Diane Hagerty, VP of Quality Systems, Genentech, USA Eric Thostesen, Senior Director, Strategic Business Support, Regulatroy Compliance, Janssen Pharmaceutical Company Inc. of J&J, USA
13:00 - 14:00	Lunch in Exhibit Hall
14:00 - 15:00	Supply of Medicines To the EU Gerald Heddell, Director, MHRA, MHRA, United Kingdom
15:00 - 15:15	Networking Break
15:15 - 17:00	Industry Lead Hot Topic Discussion Forum Carol Bye, VP, Pharm Sci, Quality Ops, Pfizer Worldwide Research and Development, United Kingdom Jaspreet Gill, VP, Global Quality-Compl., Baxter Healthcare Corp, USA Brian Lange, PE, Executive Director - Global Supply Chain, Merck & Co Inc, USA John Pinion, Global Head of PT Quality & Compliance, Genentech/F. Hoffman La Roche Ltd., USA Andrew Skibo, Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca, USA
17:00 - 18:30	Networking Reception in Exhibit Hall
Wednesday, 12 June
09:00 - 09:45	ISPE Drug Shortage Survey Results Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals, Belgium ISPE Drug Shortage Survey Results
09:45 - 10:30	Consequences of Drug Shortages Valerie Jensen, Asso. Dir. for Drug Shortage, CDER, FDA, Consequences of Drug Shortages
10:30 - 11:30	Networking Break
11:30 - 12:30	Drug Shortage Panel Discussion Valerie Jensen, Asso. Dir. for Drug Shortage, CDER, FDA, Zena Kaufman, Sr. VP Global Quality, Hospira, USA Stephen Mahoney, Senior Advisor Global Quality & Compliance, Genentech Inc, USA Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals, Belgium Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
12:30 - 13:30	Lunch in Exhibit Hall
13:30 - 15:30	Breakout Session - Quality Metrics Ferdinando Aspesi, VP, Senior Advisor, Novartis, USA OOS/Lab Failures Michael Davidson, VP Contract Operations QA, Pfizer, USA Batch Failure Rate Richard Friedman, Associate Director, OMPQ, FDA/CDER, USA Batch Failure Rate Francis Godwin, Team Lead, FDA, USA Right First Time Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA Right First Time Carmelo Rosa, Director, DIDQ, FDA, USA OOS/Lab Failures Lorraine Thompson, Quality Systems Implementation Director, Novartis, USA Potential Leading Metrics Russell Wesdyk, Science Coordinator, US FDA, USA Potential Leading Metrics
13:30 - 15:30	Breakout Session - Controlling Pharma Data in the Cloud Mebrahtu Kahsai, Abbott Molecular, Implementation of a Cloud-Based LIMS Solution Jay Kelley, Design Architect, Starlims, Implementation of a Cloud-Based LIMS Solution Jason Silva, CEO, Sidus Data, USA Considerations for Successful Regulated Cloud Deployments Keith Williams, Chief Executive Officer, GxPi, United Kingdom Cloud-Based CAPA
15:30 - 16:00	Networking Break
16:00 - 17:00	Vision for Quality Howard Sklamberg, J.D., Director, Office of Compliance, FDA,
Thursday, 13 June
07:30 - 09:30	Breakfast with the Inspectors Ernie Bizjak, Compliance Officer, OHHS/FDA/ORA/OGROP, USA Brooke Higgins, Pre-Approval Mgr/Investigator, OHHS/FDA/ORA/OGROP, USA Carmelo Rosa, Director, DIDQ, FDA, USA
09:30 - 10:30	Leaderships Role in the Culture of Quality John Pinion, Global Head of PT Quality & Compliance, Genentech/F. Hoffman La Roche Ltd., USA
10:30 - 11:00	Networking Break
11:00 - 13:00	Breakout Session - Process Performance and Product Quality Monitoring Systems (PPPQMS) Joseph Famulare, Vice President, Genentech Inc, USA Jaspreet Gill, VP, Global Quality-Compl., Baxter Healthcare Corp, USA Establishing and maintaining a State of Control Karthik Iyer, Senior Policy Analyst, FDA, USA Regulatory Overview PPPQMS Claudia Lin, PhD, Berkeley Site Head, QA-Dev, Bayer Healthcare, USA Role of the Quality Steward Keepig a Pulse on the Overall Health of the Product George Millili, Ph.D., Director, Pharmaceutical Commercialization Technology, Merck & Co Inc, USA Jason Orloff, Principal Statistician, PharmStat, USA Variability, Process Capability and Control - How Do You Determine the Right Metrics?
11:00 - 13:00	Breakout Session - Continually Investing in Your Facilities and Equipment Steven Driver, PhD, Global Energy Prog. Director, Genzyme/Sanofi, USA Sustainably Commissioning Central Chilled Water Systems Steven Lynn, Sr Advisor To Asst. Comm Ops, FDA, USA Carmelo Rosa, Director, DIDQ, FDA, USA Recent Observations at Outdated Facilities and the Impact on Supply Chains
11:00 - 13:00	Breakout Session - CAPA and Lifecycle QRM Susan Busse, Dir. Global Quality Systems, Eli Lilly & Co, USA CAPA - Shifting Gears from Correcting to Preventing Problems Richard Friedman, Associate Director, OMPQ, FDA/CDER, USA Risk Review and Management Responsibilities of CAPA Chris Milano, PhD, Sr Director, Quality Ops, Merck, Inc., USA Quality Risk Management - CAPA System
13:00 - 14:00	Lunch in Exhibit Hall
14:00 - 16:00	Meet the Press Ilisa Bernstein, Pharm.D., J.D., Deputy Dir., Office Compl., CDER, FDA, USA Joseph Famulare, Vice President, Genentech Inc, USA Richard Friedman, Associate Director, OMPQ, FDA/CDER, USA Gerald Heddell, Director, MHRA, MHRA, United Kingdom Cindy Salamon, VP, Global Quality Services, Bristol-Myers Squibb,
16:00 - 16:30	Closing Remarks Nancy Berg, President and CEO, ISPE, USA

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