Education Sessions

1A: Benefits of PAI Readiness and Data Integrity for Speedy Approvals

Moderator: J. David Doleski, Supervisory Consumer Safety Officer, DMPQ, CDER, FDA, USA

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1B: Why It Pays to Continually Reinvest in Your Facilities & Systems

Moderator: Steven Lynn, Office Director (acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER, FDA

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2A: Regulatory Success in a Cloud Environment

Moderator: Randy Perez, Director, Information Governance and Management, Novartis, USA

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2B: Sustaining Compliance Consistency throughout Your Supplier Networks

Moderator: Michael Arnold, R.Ph., Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies, USA

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Forum 1: Industry-Led Hot Topic Discussion Forum

Industry leaders will facilitate a group discussion to identify critical industry issues, concerns, needs for clarity, and opportunities for collaboration.

Moderator: Brian Lange, P.E., Operations Director- Merck Manufacturing Division, North American Operations and Consumer Care, Merck, USA

3A: Watching Your Process – Assuring Quality in Process Performance

Moderator: Joe Famulare, Senior Director, Genentech, USA

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3B: Quality Risk Management: Using Risk Assessments in Manufacturing

Moderator: Michael Smedley, Supervisory Consumer Safety Officer, CDER, FDA, USA

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4A: Flexible Manufacturing

Moderator: Jim Breen, Vice President Project Management, Johnson & Johnson, USA

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4B: CAPA Case Studies

Moderator: Rick Friedman, Associate Director for Risk-Science Intelligence and Prioritization, OMPQ, OC, CDER, FDA, USA

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Forum 2: Meet the Press

Mixed panel of regulators and industry answering today’s most pressing questions.