Regina Choi-Rivera

Nov 29, 2023 | bioprocessonline.com | Eric Gudorf |Erika Morris |Regina Choi-Rivera |AGC Biologics

Improving Resilience Of Post-Pandemic Biopharma Supply ChainsImproving supply chain resilience is critical for biopharma. One lesson learned from the pandemic is the need for new models and approaches to managing supply chains. Download our white paper to learn more about how a value chain model mitigates risk, the four critical ingredients to supply chain resilience, and why preparations based on "the last war" aren’t enough.

Feb 13, 2023 | outsourcedpharma.com | Peter H. Calcott |Lea Joos |Regina Choi-Rivera |Lei Zheng |Louis Garguilo

By Peter H. Calcott, Ph.D., president and CEO, Calcott Consulting LLC The new EMA GMP Annex 1, Manufacture of Sterile Medicinal Products, is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.