ISPE Milan Conferences - Kereon AG

Risk Management and ICHQ9
30 November - 1 December 2005
Conference Leaders
David Selby, Selby Hope International, UK
Luca Vietry, CSV Life Science Srl, Italy
Programme
14
Conference Description
The EU and FDA regulators’ recent introduction of the
concept of risk management into many aspects of GXP
compliance has caused the pharmaceutical industry to
take a serious look at how it does business. This
Conference will provide an overview of the issues
commonly faced in a highly regulated industry and
demonstrate, though current examples, how the
industry is responding to the challenges arising from the
introduction of risk management.
This Conference will bring you up to date on the current
thinking for applying risk management in the highly
regulated pharmaceutical manufacturing arena,
including an update on the ICH Q9 work and the FDA's
initiative, “Pharmaceutical GMPs for the 21 st Century - A
Risk-Based Approach.” You'll also hear examples of
how the FDA is approaching inspections and how the
risk management concept will evolve into the future.
Additionally you will hear how companies have applied
the concepts of risk management in their compliance
activities and also how other regulated industries make
use of risk management.
Learning Objectives
At the conclusion of this conference, delegates will be able to:
• Understand the principles of risk management and
the regulatory expectations
• Describe the benefits received from the risk based
approach applied to the activities of facility planning,
revamping and new design
• Explain the use of risk management in integrated
commissioning and qualification projects
• Explain the use of risk management in validation
planning
• Explain the use of risk management for applying
controls to electronic records
• Understand the implications of the FDA's risk-based
approach for the pharmaceutical industry
• Discuss how the initiative is developing
• Appreciate the issues raised by examining current
examples
Who Should Attend
• Professionals involved in the pharmaceutical supply
chain who are new to the industry, or industry
veterans who want to learn about the new
approaches to risk management
• Production and operations managers
• Quality assurance and quality control executives
• Process engineers
• Maintenance engineers
• Validation executives
Agenda
Wednesday, 30 November
10.00 - 10.15 Welcome and Introduction
David Selby, Selby Hope International, UK
Luca Vietry, CSV Life Science Srl, Italy
10.15 - 11.15 FDA Regulatory Expectations with Regard
to Risk
Speaker to be confirmed
11.15 - 12.15 European Regulatory Approach to Risk
Management
Speaker to be confirmed
12.15 - 13.30 Lunch
13.30 - 14.30 Risk Assessment – Lessons Learnt From
Other Industries 1 – Aerospace: Some Aerospace
Specificities and Trends Significant for a Risk
Assessment Approach
Alain Dupas, Collège de Polytechnique, France
• Specificities
• Very complex systems (number of parts: 100,000s)
• Integration in larger “systems of systems”
• Huge unitary cost (US$ 10/100s millions) and small series
(10s to 100s units)
• Long development cycle and innovative technologies
• Failures associated with large human and financial losses
• Pressure on operational costs
• Globalisation of manufacturing and issues of subcontractors
selection
• Trends
• Risk becoming a major corporate management problem
(reliability and failure impact results and market
perception)
• Technical risk difficult to apprehend by top
management, creating strong demand for clear and
operative risk assessment tool
• Statistical risk assessment often irrelevant
• Risk assessment must become deterministic and part of
decision making process