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Collaborate with Industry and Regulatory Leaders to Resolve Quality Challenges
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The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges around quality issues. Sessions are designed around open discussion about current FDA priorities and industry-critical quality initiatives.
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Industry and FDA Keynotes:
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Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality, FDA/CDER
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François Sallans, PharmD
Vice President, Quality & Compliance, Chief Quality Officer
Johnson & Johnson
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Thomas Cosgrove, JD
Director, Office of Manufacturing Quality, FDA/CDER/OC
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Core topics are featured throughout the conference education program to provide diverse perspectives:
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Clinical Relevance
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Explore the impact on drug safety and efficacy of using acceptance criteria based on clinical relevance.
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Emerging Technology and Innovation
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Understand the processes, challenges, and paths to success using the FDA’s new guidance and industry best practices.
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Facility and Life Cycle Quality Management
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Examine the importance of facility systems, utilities, equipment, qualifications, and preventative maintenance in a holistic life cycle approach.
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| Quality Metrics
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Collaborate with the FDA and industry on using quality metrics to drive quality and operational excellence, building upon learning from the ISPE pilots and quality culture work.
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Take Advantage of Additional Events Being Held in Conjunction
with the Conference:
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Exhibit and Onsite Branding Opportunities
Contact Alisa Pachella, Sales Account Manager, at
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ISPE | 600 N. Westshore Blvd. | Suite 900 | Tampa, FL 33609 USA
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