The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
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 |
Michael Kopcha, PhD, RPh Director, Office of Pharmaceutical Quality Offices and Leadership, FDA |
Steven Solomon, PhD Deputy Associate Commissioner for Regulatory Affairs, FDA/ORA |
Gain valuable information from 4 Education Tracks:
View the detailed quality manufacturing conference agenda for speaker and session information.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...