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November 18, 2021
Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.
November 17, 2021
Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.
November 16, 2021
Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.
November 15, 2021
Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.
November 12, 2021
The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.
November 02, 2021
Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
October 28, 2021
FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.
October 22, 2021
The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.