PDA Letter

March PDA Letter

Podcast

Our February podcast is now available! Listen to speakers at the 2014 PDA Europe Parenterals conference discuss future trends in manufacturing.

Listen to our previous podcast archive

  • Technology Column: Water Testing Lab Automates its Way to Efficiency

    by Simon in ‘t Veld, Vitens | Feb 27, 2015
    How do you merge three regional water supply testing laboratories into one without losing efficiency and increasing errors? Build a state-of-the-art lab using the latest microbiology and chemical tests combined with automation and robotics, that’s how.
    Full story
  • Want to Make the FDA Quality Dean’s List? Take a Look at Your Metrics

    by Walter Morris, PDA | Feb 27, 2015
    No one can say for sure what the ultimate impact of the U.S. FDA’s pharmaceutical quality metrics initiative will be on both pharmaceutical manufacturers and the Agency’s enforcement practices. A vision of what the future holds, however, materialized during the 2014 PDA Pharmaceutical Quality Metrics Conference in Washington, D.C., Dec. 2–3.
    Full story
  • Moving Beyond “Read and Understand” SOP Training

    by Vivian Bringslimark, HPIS Consulting, Inc. | Feb 27, 2015
    It used to be adequate enough to show training records as evidence of trained employees. And then regulatory inspectors began asking about the effectiveness of our training programs. So we added the ubiquitous “quiz” conducted at the conclusion of training, and for a while this was acceptable as a practice. These “quizzes” maybe measure knowledge retention, and possibly, comprehension, if they include challenge questions about real workplace situations. But having a quiz is no guarantee that the employee transformed the knowledge itself into a skill that can be performed correctly back on the job, especially when the original training was conducted via the “Read and Understand” technique.
    Full story

Read the Full March Issue (Members Only)

The U.S. FDA’s push for quality metrics continues to gain momentum. But what does this mean for the future state of pharma?

Science

Technology Column: Water Testing Lab Automates its Way to Efficiency
Simon in ‘t Veld, Vitens

Sterility Challenges, Complexities Require New Tools
Michael Sadowski, Baxter Healthcare

Packaging Playing a Greater Role in Future of Pharma
Ronald Iacocca, PhD, Eli Lilly, and Diane Pasket, West

SUS Success Needs Knowledge Sharing, Transparent Partnership
Robert Repetto, PhD, Pfizer, and Morten Munk, NNE Pharmaplan

Features

Want to Make the FDA Quality Dean’s List? Take a Look at Your Metrics
Walter Morris, PDA

Regulatory Take on Quality Metrics and Culture
Transcript from the final panel at the 2014 PDA Pharmaceutical Quality Metrics Conference

Infographic: Making a Masterpiece of Manufacturing

Regulation

No Surprises for FDA at History Advisory Committee Meeting
Denyse Baker, PDA

Moving Beyond “Read and Understand” SOP Training
Vivian Bringslimark, HPIS Consulting