Q11 Development and Manufacturing of Drug Substance
Quality Risk Modeling and Management
Excipient Risk-Assessment Guidance
OPQ Perspectives on Risk-Based Review
Inspection of Combination Products
Product Traceability Implementation
Frontiers in Manufacturing Science and Quality
FDA New Technology Initiative
Latest Developments in 3D Printing, Nanotechnology, High-Potency Drugs, and Injectables
FDA/Industry Collaborations in Innovation
Impact of Emerging Technologies on Manufacturing Development
Manufacturing and Operational Excellence
Manufacturing Issues Impacting Drug Shortages
Critical Excipients in the Supply Chain
Controlling Supply Chain Variability
Driving a Culture of Continuous Improvement
ICH Q12 on Currently Marketed Products
Plus, don't miss these key sessions:
Breakfast with the Investigators – Front-line regulators share their insights.
Quality Metrics – What's next? How can my company prepare for implementation?
Industry and Regulatory Discussion Forum – Face-to-face dialogue with industry thought-leaders and global regulatory representatives.
Register by 9 May 2016 and Save! Discounted Student and Group Rates are Available Learn about Exhibit and Sponsorship Opportunities Save the Date! ISPE Data Integrity Workshop: 5 June 2016 Arrive a day early to participate in this highly interactive session! Registration coming soon
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...
