|Event Date/Time: Dec 08, 2003||End Date/Time: Dec 12, 2003|
In a recently released, 5-Part Strategic Action Plan, the FDA emphasized its Science-Based Risk Management approach to enforcement. The focus on risk-based assessments when it comes to validating utilities leaves validation professionals with the need to determine exactly how it will be applied to their companies.
Making sure a clean and safe environment for the production of drugs is adequately designed, monitored and validated has never been more crucial to a drug company’s overall success. Yet, FDA guidelines can be vague. The rules sometimes vary from region to region, and the latest inspection trends are difficult to track without the perspective of colleagues who have had recent experiences.
With that in mind, IIR is pleased to present Validating Utilities: Applying Best Validation Practices to Air/Gases, Water and HVAC. The event opens with a full day, pre-conference workshop on basic, good manufacturing practices and ways to approach the validation of all utilities.
Our first conference day begins with a look at the FDA’s risk-based assessment approach to validation, and a case study involving one manufacturer’s experiences with FDA inspections in 2003. The rest of the conference is divided into validation issues in the three primary areas of air/gases, water and HVAC. Additionally, conference delegates come away with a working knowledge of software validation and the latest in part 11 compliance.
Our accomplished faculty of experts have first-hand experience in the best approaches to assure compliance and simplify utilities validation. This event provides the information you need to implement a validation program, and addresses areas including how to:
Implement your own approach to FDA’s risk-based inspections
Analyze validation plans for HVAC that minimize regulatory risk
Apply the underlying principals for validating water systems
Design your own water system for ease of validation
Integrate compressed air validation strategies
Evaluate latest technologies in validating a building maintenance system
Apply the latest on FDA Part 11 compliance
Get back to basics in our hands-on workshop Best Practices in Validation
Join our speaking facility from leading organizations such as: Analex Corporation, DSM Catalytica Pharmaceuticals, Facility Diagnostics, IPS, OSG Norwich Pharmaceuticals, Stelex- The Validation Group, US Filter, and Wyeth Pharmaceuticals, Validating Utilities, 2003 is designed to meet your crucial utility validation needs. We look forward to seeing you December 8 - 10 in Philadelphia!