| Tuesday, 11 June |
| 08:20 - 08:30 |
Welcome, Opening Remarks
|
| 08:30 - 09:30 |
Industry Plenary Presentation
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Jaspreet Gill, VP, Global Quality-Compl., Baxter Healthcare Corp, USA
|
| 09:30 - 10:30 |
Plenary Presentation - Quality Pays for Itself
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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
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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
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David Doleski, Director, Division of DGMPA, CDER / FDA Office of Compliance, USA
Challenges to Inspection Readiness
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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
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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
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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
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Monica Caphart, Supervisory Consumer Safety Officer, DMPTPO/OMPTO/OO/ORA, USA
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Victor Gaines, Chemist, CDER/FDA,
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Diane Hagerty, VP of Quality Systems, Genentech, USA
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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 |
Plenary Presentation - Supply of Medicines To the EU
|
| 15:00 - 15:15 |
Networking Break
|
| 15:15 - 17:00 |
Industry Lead Hot Topic Discussion Forum
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Carol Bye, VP, Pharm Sci, Quality Ops, Pfizer Worldwide Research and Development, United Kingdom
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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
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Valerie Jensen, Asso. Dir. for Drug Shortage, CDER, FDA,
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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
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Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
|
| 12:30 - 13:30 |
Lunch in Exhibit Hall
|
| 13:30 - 15:30 |
Breakout Session - Quality Metrics
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Ferdinando Aspesi, VP, Senior Advisor, Novartis, USA
OOS/Lab Failures
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Michael Davidson, VP Contract Operations QA, Pfizer, USA
Batch Failure Rate
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Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA
Right First Time
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Lorraine Thompson, Quality Systems Implementation Director, Novartis, USA
|
| 13:30 - 15:30 |
Breakout Session - Controlling Pharma Data in the Cloud
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Boaz Gur-Lavie, Vice President, Finance, STARLIMS Corporation,
Implementation of a Cloud-Based LIMS Solution
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Mebrahtu Kahsai, Abbott Molecular,
-
Jay Kelley, Design Architect, Starlims,
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Jason Silva, CEO, Sidus Data, USA
Considerations for Successful Regulated Cloud Deployments
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Dimitrios Tsarouhtsis, Senior Quality Manager - Quality Control, Abbott Molecular,
Implementation of a Cloud-Based LIMS Solution
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Keith Williams, Chief Executive Officer, GxPi, United Kingdom
Cloud-Based CAPA
|
| 15:30 - 16:00 |
Networking Break
|
| 16:00 - 17:00 |
Plenary Presentation: Vision for Quality
|
| Thursday, 13 June |
| 07:30 - 09:30 |
Breakfast with the Inspectors
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Ernie Bizjak, Compliance Officer, OHHS/FDA/ORA/OGROP, USA
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Brooke Higgins, Pre-Approval Mgr/Investigator, OHHS/FDA/ORA/OGROP, USA
-
Carmelo Rosa, Director, DIDQ, FDA, USA
|
| 09:30 - 10:30 |
Plenary Presentation - 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
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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
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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
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Joseph Famulare, Vice President, Genentech Inc, USA
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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
|
Thank you to our Top Tier Sponsors
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