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Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.
Sommario
H.R. 3204 – The Journey and Expected Destination. The World of Human Drug Compounding – Hope and Change! Pharmacy Compounding – The Supply Chain World. Track and Trace – Not Hide & Seek! Land of the Giants – and Land of the Totes! The Customer/Patient Touchpoint – Literally and Electronically! When Things Go Bump In The Night: Reverse Logistics. All Those "Lettered" Government Agencies. Pulling It All Together: Public Policy and Other Items of Note. Drug Quality and Security Hall of Fame.
Info autore
Karl F. Kuglin is a professional services consultant with Ernst & Young LLP in the EY Life Sciences industry group. He helps pharmaceutical companies to adapt and lead change to the industry, including emerging science, new products and services, shifting demographics, evolving regulations (such as the Drug Quality and Security Act), transforming business models, and increased stakeholder expectations.
Kuglin has operational leadership experience with one of the leading return logistics companies in the pharmaceutical industry. This experience includes an in-depth knowledge of the regulations governing pharmaceutical drugs (including controlled substances). He led a team responsible for the receipt, processing, return to manufacturer, and destruction of returned pharmaceutical drugs, and the accuracy of the application for credit allowances to pharmaceutical manufacturers. His contribution to Chapter 7, “When Things Go Bump in the Night: Reverse Logistics,” was invaluable. Kuglin is a graduate of Indiana University with a major in business administration.
