Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation
June 29, 2017
Senior Validation and Risk Consultant Christopher M. Hanff has been published by Pharmaceutical Online. Pharmaceutical Online provides the pharmaceutical manufacturing and packaging industry with exclusive and actionable information to help industry members tackle the challenge of bringing life-saving and life-improving therapies to market. Hanff’s article, “Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation” addresses how shipping validation can act as a vehicle, delivering improvement throughout the entire pharmaceutical quality system.
“Shipping validation, though generally simpler than manufacturing process validation, still warrants an effective and efficient approach to assure product quality and availability,” Hanff said. “A right-sized approach to pharma product shipping validation can deliver both effectiveness and efficiency.”
Christopher M. Hanff has over 18 years of experience in biopharmaceutical development, operations, lean manufacturing, and quality systems. He contributed to and led a number of projects ranging from suite start-ups, design-construction, and commercialization efforts, to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree. Hanff continues to lead ValSource’s efforts, advocating for greater efficiency and effectiveness in all areas of Active Transport Validation.