PDA Letter

PDA Letter
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PDA Letter

 •  January 16

Is the industry ready to move from large biotech facilities to modular, predesigned and prefabricated facilities? According to Maik Jornitz in his Oct. 17 PDA Metro Chapter presentation, “Future Facility and Process Needs – Where are We and What do We Need?”, the answer is “yes.”

PDA Letter

 •  January 9

Reports from the 2017 PDA/FDA Joint Regulatory Conference Quality is essential no matter how revolutionary the drug product. That concept permeated the 2017 PDA/FDA Joint Regulatory Conference: “Ensuring Product Quality in an Era of Innovative Therapies,” Sept. 11–13, in Washington, D.C. Three sessions in particular emphasized the spirit behind the...

PDA Letter

 •  January 9

Reports from the 2017 PDA/FDA Joint Regulatory Conference The 2017 PDA/FDA Joint Regulatory Conference in Washington, D.C., focused exactly on that: How can industry and the U.S. FDA adapt current quality standards to innovative therapies? As not everyone could attend the Sept. 11-13 event—though this is a “must” meeting for me—I would like to...

PDA Letter

 •  January 2

Have you created the tools to respond quickly to customer needs and market changes while still controlling costs and quality? Do you know which technology and digital trends are shaping the future of healthcare? Is your company proactively solving complex problems in a time of hyper change and increased competition? Are you and your teams taking...

PDA Letter

 •  January 2

Recent Advancements Address Regulatory Requirements for Monitoring of Cleanrooms Viable air monitoring is a crucial part of an environmental monitoring program. Because common viable air monitoring methodologies have not been introduced in many years, monitoring in critical manufacturing areas like Grade A, RABS and isolators creates a dilemma for...

PDA Letter

 •  January 2

Susan Laska, Senior Advisor for Medical Products and Tobacco Operations, Office of Regulatory Affairs, FDA, shared these figures in the opening slides of her Oct. 18 presentation, “FDA’s Mutual Reliance Initiative,” at the 12th Annual PDA Global Conference on Pharmaceutical Microbiology. Her talk offered a look at the new Mutual Reliance Agreement...

PDA Letter

 •  January 2

The 12th Annual PDA Global Conference on Pharmaceutical Microbiology concluded with an “Ask the Regulators” panel. Throughout the conference, attendees could submit their questions on cards that were later collected and distributed to a panel of U.S. FDA regulators specializing in microbiology. Attendees could also ask questions at the microphone...

PDA Letter

 •  January 2

In September, PDA submitted comments on a recent WHO draft guidance regarding alignment of post-approval change requirements across jurisdictions. While PDA recognizes the need for harmonization, the Association also pushes WHO to consider moving fro end-product testing to upstream controls for better process understanding.

PDA Letter

 •  December 13, 2017

The manufacturing world is undergoing its fourth industrial revolution, known as Industry 4.0, spurred by the proliferation of digital capabilities (i.e., Internet of Things), and the integration of these capabilities into existing production and supply systems. We cannot ignore the impact of technology on the way manufacturers—including those in...

PDA Letter

 •  December 5, 2017

Imagine having the opportunity to participate in hands-on activities around the latest aseptic processing techniques. For 50 members of PDA’s newest chapter, Brazil, this was an opportunity realized.