June 20th 2025
Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.
Quality Considerations in Changing Excipient Providers
June 26th 2024In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.
Elements for a Sustainable Environmental Monitoring Program
June 2nd 2024Asking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.
Contamination Control Strategies for Cell and Gene Therapy Facilities at INTERPHEX 2024
April 22nd 2024At INTERPHEX 2024, a panel of experts gave insight on new regulatory requirements for contamination control and provided advice for how to implement a contamination control strategy in existing facilities.