ISPE Conference on Manufacturing Excellence
25-28 February 2008
Hyatt Regency Tampa
Tampa, Florida, U.S.
Process Validation: Today’s Practices and Tomorrow’s Opportunities
27-28 February
1.2 CEUs
The complexity of manufacturing operations in today’s pharmaceutical and biotechnology companies creates new and unique challenges for system verification and process validation. Controlling the process using well-defined operating parameters and raw materials is critical, yet more complicated. This seminar focuses on how companies in both the pharmaceutical and biotechnology industries implement new tools and strategies to reduce risk and improve the efficiency of process validation.
Discussion topics include:
- Different challenges faced by traditional pharmaceutical and biotechnology companies to verify and validate processes;
- Trends in cleaning and equipment validation;
- Proven methods of validating viral clearance;
- Functional criticality of operational aspects related to product quality; and
- The challenges of validating APIs under the Q7A guidelines.
- Recently, ISPE developed a new ASTM consensus standard for risk-based verification/validation. This consensus standard will be presented and discussed. This session will cover an update on the most current status of the FDA’s new guidance on validation.
- In addition, learn how companies are continuing to execute risk-based activities to improve their effectiveness (outside of PAT). Case studies illustrate how process validation challenges were met in situations common to the industry.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Discuss process validation strategies that focus on risk assessment and risk mitigation
- Understand the synergy between process validation and advances in process control and automation
- Describe how companies are defining execution strategies to optimize both
Who Should Attend
Process engineers, automation engineers, and validation technicians
Communities of Practice (COPs)
GAMP, Process/Product Development, Biotech, JETT, and PAT
Related Technical Documents
Available from ISPE - www.ISPE.org/publications
GAMP 5, Baseline® Guide Series
Seminar Leaders
- Rusty Morrison, Manager/Validation Engineer, Commissioning Agents Inc
- Thomas Ofsharick, GMP Compliance Manager, GlaxoSmithKline
- Mark Yates, Manager Technology, Wyeth
Speakers
- Janet Bowen, Principal Consultant, Commissioning Agents Puerto Rico Int'l
- John Davis, Director of Validation, Eisai Inc
- John Dietrick, Consumer Safety Officer, FDA/CDER
- Shawn Gould, Senior Biochemical Engineer, Emergent BioSolutions
- Dave Grote, Senior Manager, Process Validation, Amgen Inc
- Sean McNiven, Process Development Engineer, Abbott Vascular
- Peter Watler, PhD, JM Hyde Consulting Inc.
- Graham Wrigley, PhD, Senior Mgr Validation, Pfizer