Complying with the regulations of the US Food and Drug Administration is more of an art than a science, says Medina (president, Precision Consultants, Inc.). He presents 17 papers addressing some of the more important compliance and quality systems used in FDA-regulated industries related to medical devices, pharmaceuticals, and biologics. Specific topics include validating analytical methods for pharmaceutical applications, stability testing, computer validation, vendor qualification, internal audit programs, and strategic planning for compliance and regulatory defensiveness.
