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PDA Post-Approval Change Issues and Impacts Survey
This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.
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Take PDA's COVID-19 Survey in Pharmaceuticals
The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.
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PDA’s First Drug Delivery Innovation Award Winners at 2019 Universe of Pre-Filled Syringes and Injection Devices Conference
One award winner includes a thinner needle to reduce injection pain, while a partnership resulted in a precise microliter dosing syringe.
Materials & containers
Particles in Parenterals: 2019 Update
FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019?
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Particles in Parenterals: 2019 Update
FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019?
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PDA Quality Culture Assessment
How can you “measure” the culture at your organization, or that of potential partner? PDA developed a tool to evaluate quality culture and a case study for training, built on the premise of a firm evaluating a potential CMO.
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PDA Container Closure Performance and Integrity Conference in June
At the event in Bethesda, MD, exchange ideas with industry peers and regulatory experts on meeting packaging demands for new medicines, novel delivery devices, and evolving regulations.
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Data Integrity Code of Conduct
While the FDA asks pharma companies to heed its warnings around good manufacturing practices, the Parenteral Drug Association outlines actions to take.
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Managing the Risks of Temperature Excursions
Baxter’s voluntary recall serves as a reminder of the importance of managing life science product temperatures through the supply chain.