PDA

More from PDA

Getty Images 488635873

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.

Getty Images 116406615

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.

Hulio wins PDA award for device innovation.

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.

Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.

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?

Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.

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?

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.

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.

PDA Container Closure Performance and Integrity Conference in June

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.

Els Poff, Executive Director of the Data Integrity Center of Excellence at Merck

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.

Managing the risks of temperature excursions is of vital importance for many life sciences products.

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.