home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

The Pharmaceutical Supply Chain: Good Distribution Practices

 
  July 10, 2013  
     
 
CfPA - The Center for Professional Advancement, New Brunswick, NJ
December 12-13, 2013


Who Should Attend
This course is intended for professionals working in the Pharmaceutical, Biotechnology, Medical Device and other related industries. It will be especially valuable for personnel involved in the following areas:

  • Supply Chain Management
  • Quality Control/Assurance
  • Logistics & Shipping
  • Documentation
  • Receiving
  • Packaging Design & Floor
  • Risk Management 
  • Current or Prospective Suppliers of Drug Products

Description
This intensive, 2-day course uses current regulatory agency regulation, guidance and pharmacopeia chapters from around the world to cover the best practices for distribution of drugs and biological products. If followed, these Supply Chain Essentials ensure that drug products (medicines) reach the end user (practitioners and patient/consumers) with their quality intact. Special emphasis will be placed on key aspects of the distribution process (e.g., Service Level Agreements (commonly referred to as a Quality Agreement; temperature mapping; and handling temperature excursions).

Packaging, QA, logistics and regulatory departments must ensure they understand and implement the requirements needed to ensure drug product reaches the end user safely. In this course, supply chain stakeholders will discuss how to collaborate and implement solutions to ensure an effective means of delivering temperature controlled life science products globally. We will discuss current international regulatory requirements on distribution practices and how to comply with these requirements for medicines within the USA or out to global markets.

There will be deep dive discussions on packaging for drug product distribution with emphasis on materials, collaboration with land, sea, rail and air shipping firms, importation requirements and developing a global shipping qualification Master Plan down to the last mile of distribution.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Dr. Mary Foster; Corp VP Quality and Regulatory Affairs, Aphena Pharma Solutions

Dr. Mary Foster is Corporate VP, Quality & Regulatory Affairs for Aphena Pharma Solutions and former VP Regulatory Compliance for Catalent Dr. Foster is a Regulatory Affairs/Quality professional with 30+ years background in human and veterinary pharmaceuticals, OTC monograph drugs, dietary supplements and medical devices, all in one or a combination of QC, QA and Regulatory Affairs/Compliance capacities for manufacturing, packaging and holding of product (including world wide cGMP compliance and DEA). She has been responsible for developing site implementation plans to enhance regulatory compliance on a global basis. These plans include education programs, quality system management initiatives and recommendations for continuous improvements relative to regulatory agency requirements.

Dr. Foster is currently Chair of the USP Expert Committee n Packaging, Storage and Distribution of Drug Products. Dr. Foster received her Doctor of Pharmacy and Bachelor of Science degrees from the University of Kentucky.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.