In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, ...
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some ...
The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways.
The spring of 1997 was a significant time for theFood and Drug Administration (FDA). An overhaul of the Agency’s Good Manufacturing Processes (GMP) brought changes that had not been seen for a quarter ...
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