Tuesday, July 30, 2019 | 2:00 PM EDT, 11:00 AM PDT
In this free webinar, the featured speaker will demonstrate how the Quality by Design (QbD) cascade ensures FDA expectations are not only met but are clearly articulated in specific terms. This presentation will include an in-depth overview of all four stages of the QbD process. Register Now.
By Louis Garguilo, Chief Editor, Outsourced Pharma
Recent CDMO marketing extolling “the only end-to-end services" hasn’t been universally well received by the biopharma professionals it is targeting. Might we start questioning how truthful all CDMO marketing is as a result? That wouldn’t be good for the drug development and manufacturing outsourcing industry.
How can the industry improve the quality of its products? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.
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By B. Rosenblatt, Ph.D., SME Biotech Consulting, and D. Kenyon, Ph.D., Thermo Fisher Scientific
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
By Nicolas Girard, Ropack Pharma Solutions and Graham Clark, TraceLink
This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.