Choose from any of the following specialized knowledge categories:
Manufacturing Technology | Manufacturing Facilities and Design | Investigational Products | Information Systems | Regulatory Compliance | Project Management | Quality Systems | Young Professionals | Executive Series
State-of-the-Art Manufacturing Technology - Explore solutions to challenges such as single-use and modular technologies, current state-of-the-art aseptic processing equipment and facilities and the next generation of emerging API and Drug Product development and manufacturing technologies.
Leader: Emily Stump, Validation Scientist, Commissioning Agents, Inc.
Manufacturing Facilities and Design - When considering either building a new biopharmaceutical manufacturing facility or modernizing an existing one, this track will help you find advanced information and case studies based on best available practices utilized in facility design.
Leader: Michelle Gonzales, Principal, BioPharm Engineering Consultant
Leader: Steven Yoder, General Manager, Fisher Clinical Services
Information Systems: Pharmaceutical Lifecycle Data Integrity Expectations - Gain an understanding of the current regulatory expectations, guidance and enforcement strategies for identifying and applying appropriate data integrity control strategies for critical data and key quality attributes throughout the lifecycle based on QBD principles.
Leaders: Kevin Martin, Senior Vice President, Azzur Group LLC and Randy Perez, Director, IT Risk Mgt Compliance, Novartis Pharmaceuticals
Regulatory Compliance: Improving Drug Quality and Availability: Preparing for Beyond 2013 - Learn through case studies and gain an insight from regulatory and industry leaders on the opportunities and challenges presented by "pharmemerging" issues.
Leaders: Stephen Tyler, Director Quality Engineering, AbbVie; Joseph Famulare, Senior Director, Genentech Inc.; Charles Hoiberg, Executive Director, Pfizer, Inc. and Bob Baum, Regulatory Affairs, ISPE
Project Management: Assuring Quality Throughout the Project Management Lifecycle - The ISPE Project Management COP will be delivering content based training through real-world examples and use interactive tools to showcase the entire lifecycle of project management.
Leader – Keith Gibbs, Director of Project Delivery, Innovative Process Solutions
Quality Systems: Application of Pharmaceutical Quality System Elements that Impact the Engineering Lifecycle - This track focuses on the development of skills, techniques and attitudes needed to form successful collaboration between Pharmaceutical Quality System Elements and the Engineering Lifecycle.
Leaders: Rose Mary Dollard, Director, Compliance Remediation, Johnson & Johnson and Tim Howard, Vice President, Commissioning Agents, Inc.
Leaders: Jennifer Lauria-Clark, SE Manager Technical Services, Commissioning Agents, Inc. and Brody Stara, Process Engineer, CRB Consulting Engineers(NMO)
Leader: Gordon Leichter, Regional Sales Manager, Belimed, Inc.