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2016 Archive

  • January 2016
    Postapproval changes are a major issue for our industry, with implications for the adoption of new technology. Baxter’s Jenifer Avenatti looks at how product-based impact assessments could help with the postapproval change process. Barbara Jentges discusses how simplification of marketing authorization processes could help ease postapproval changes in Europe. Plus, two members of the PDA Letter Editorial Committee report on the first two days of the 2015 PDA/FDA Joint Regulatory Conference.
  • February 2016
    What do you do if your facility’s control system is out of date? Timothy Miller and Andy Miller from Xellia Pharmaceuticals offer their four-step strategy for updating an aging control system. Thomas Peither covers the U.S. FDA’s views on aging facilities. Plus, read articles previewing this year’s PDA Annual Meeting.
  • March 2016
    How does the Long Tail impact the future of manufacturing? Rebecca Stauffer writes about how industry is moving to flexible manufacturing in response to the move away from “blockbuster” drugs. Plus, a survey looks at leachables studies in the area of single-use systems.
  • April 2016
    Viral clearance remains a topic of concern within biopharmaceutical manufacturing. Dayue Chen and Qi Chen look at the literature available on using retentive filters for clearance. Sven Deutschmann explores PCR-based testing for adventitious agents. And this issue’s infographic looks at the “usual suspects” of viral contamination.
  • May 2016
    Find out what happens when a vaccine manufacturer turns to Big Data to improve yield in this issue’s cover story by Rebecca Stauffer. Plus, Nanda Subbarao, a speaker at the 2015 PDA/FDA Vaccines Conference, looks at method variability. And check out photos from the 2016 PDA Annual Meeting in the Photostream.
  • June 2016
    Find out how a line of sight approach can help your company assess risk for aseptic processing. Plus, explore the seven steps for successful replication of your decontamination cycle.
  • July August 2016
    PDA celebrates 25 years of the PDA/FDA Joint Regulatory Conference. Revisit past conferences with our photo retrospective. Plus, what you need to know about ensuring data integrity from three members of PDA’s data integrity task force.
  • September 2016
    Find out how microbiologists can use statistics to calculate the percentage of biological indicators. West’s Fran DeGrazio looks at the use of QbD in prefilled syringe development. And Raphael Bar offers a case study on microbial recovery limits.
  • October 2016
    How can designating a Person in Plant improve a company’s relationship with a CMO? Find out from one company’s experience. Plus, why it pays to treat your raw material suppliers like CMOs.
  • November December 2016
    Our industry is now fully globalized. But this presents many challenges. Kelly Waldron, Luis Caveda, and Ajay Pazhayattil address some of these challenges. Rebecca Stauffer also looks at recent ICH and PIC/S initiatives. And Walter Morris explores the impact of EU anticounterfeiting regulations on the global industry.