Receive first-hand information from global regulators and gain invaluable insight to assist your company in navigating the increasingly complex nature of regulatory compliance and quality expectations at the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference. This year's conference will provide industry and FDA insights into key issues and emerging trends essential to your company's ongoing quality manufacturing efforts. Hear from 4 dynamic Keynote Speakers:
Dara Corrigan, JD Associate Commissioner for Global Regulatory Policy, FDA/OC/OGROP
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Lynne Krummen, PhD Vice President, Global Head for Biologics, Technical Regulatory and the Global Lead for Quality by Design, Genentech, Inc., A Member of the Roche Group
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Michael Kopcha, PhD, RPh Director, Office of Pharmaceutical Quality Offices and Leadership, FDA
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Steven Solomon, PhD Deputy Associate Commissioner for Regulatory Affairs, FDA/ORA
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Gain valuable information from 4 Education Tracks:
- Manufacturing and Operational Excellence – investigate practices designed to improve manufacturing and prevent drug shortages.
- Transformation of Review and Inspection in Quality Oversight – gain insight into the FDA's new focus on "One Quality Voice" through the integration of multiple review and inspection units.
- Frontiers in Manufacturing Science and Quality – explore cutting-edge developments and revolutionary approaches in drug product manufacturing and delivery.
- Progress in Quality Metrics – understand the impact of developing regulations on company program implementation and investment.
View the detailed quality manufacturing conference agenda for speaker and session information.