Journal of Developing Drugs
Open Access

Supplier management - Key components of managing suppliers in a cGMP environment

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Pejman Parhami

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

FDA holds pharmaceutical companies liable for introducing or causing the introduction into interstate commerce of adulterated or misbranded products. FDA Safety and Innovation Act explains that GMPs include owner?s ?implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials used in the manufacturing of drugs, and finished drug products.? Additionally, new draft guidance on quality agreements, describes the responsibilities of drug manufacturers with respect to oversight of their suppliers. The seminar is a discussion of supplier management covering topics such as vendor qualification, supplier assessment, quality audits, supplier performance, and quality agreements.

Biography :

Pejman Parhami completed his B.S. degree in Chemistry at the age of 20 from University of Oklahoma, and graduate studies in Chemistry from the same university. He also holds an MBA from Temple University. He is the director of Quality Systems, for Hyland?s, the largest and oldest homeopathic medicine manufacturer in the United States. He has over 27 years of experience in R&D and quality and has worked for AstraZeneca, GlaxoSmithKline, Cephalon, and MedImmune.