Education Sessions
Applied Risk Management – Addressing Cross Industry Challenges (601)
| 26 October 13.00-17.00 | Track: Project Management |
ISPE CEUs: 0.4
(PDF Current as of 28 July 2008)
Risk management is a process used within most areas of the pharmaceutical and biopharmaceutical industry - whether assessing risks in developing or manufacturing a new drug, or when building facilities to produce drugs. Within this industry, we have a vast array of potential risks, which we must identify, eliminate or mitigate, and ultimately control. Our goal is to take a risk-based approach to all aspects of the drug supply chain: from development to launch, and from launch to sustainable manufacture and sale. This session will introduce general principles of risk management, which are applicable across the industry and aims to be a practical workshop introducing different risk types and challenges:
- Quality (ICHQ9)
- Project (cost, time, scope risks)
- Operational (risks associated with health and safety, maintenance and quality)
- Business (supply chain and commercial/ competitive risks)
Subject matter experts from various Communities of Practice (COPs) will be available to present concepts, tools and case studies and facilitate interactive sessions. These interactive sessions will give delegates handson practice on how to apply tools introduced during the seminar as well as to take them away for use within their own role.
How You Will Benefit
At the end of this session, participants will be able to:
- Understand generic concepts of risk management – for example those which are as applicable to quality risk assessment as safety risk assessment
- Apply a set of basic risk management tools
- Demonstrate templates and sample model answers to interactive exercises presented
Who Should Attend
Project managers, engineers, and quality professionals
ISPE Communities of Practice (COPs)
Active Pharmaceutical Ingredients (API), Containment, Commissioning and Qualification (C&Q), Good Automated Manufacturing Practice (GAMP), and Project Management (PM)
Session Leader
- Patricia Melton, Managing Director, MIME Solutions Ltd, United Kingdom
Session Speakers
- Joerg Block, PS-TS-KM-Tech Compliance, Bayer HealthCare AG, Germany
- Bruce Davis, Principal Consultant, Global Consulting, United Kingdom
- Jeffery Odum, Principal, NCBioSource, USA