Commissioning, Qualification & Validation University
12:00 - 23:59
C&Q * Master Planning * Risk * Statistics * Chnage Control * Documentation * CPV Validation University Val-U Returns to Dublin! Knowledge Exchange Network (KENX) is very excited to announce our Validation University conference is returning to Ireland this fall. The event is a dream come true for quality, validation and engineering professionals by offering real-world training in areas of validation including pharmaceutical, biotech, medical device and related environments. Participants create their own experience by choosing from over 30 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate, actionable results. Move Past the Basics in the Most Well Rounded CQV Conference in Industry! Facility Commissioning Develop Effective Protocols and Execution Strategy Design Equipment Grouping Strategies for Validation Plan and Execute a Factory Acceptance Test/Site Acceptance Test (FAT/ SAT) Process Validation Learn How to Handle Validation Non-Conformances Implement Training for Validation Programs and Project Management Develop Validation Master Plans that Support the Project Requirements Equipment Qualification Develop Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols Learn How to Requalify Equipment, Systems and Processes Conduct Meaningful Risk Assessments on Equipment Cleaning Validation Design Cleaning Cycle and Qualification Studies for Steam Sterilization Establish Procedures and Residue Limits that are Practical, Achievable and Verifiable Reduce Risk and Contamination through Visual Inspections Computer Systems Validation Validate Manufacturing Process Automation Software Audit and Validate Paper, Electronic and Hybrid Systems, and Processes Write IQ/OQ/PQ Procedures, User Requirements and Test Scripts for New Systems Utilities Qualification Execute Storage Temperature Mapping Validations Understand how to Qualify HVAC, Water and Gas Systems Develop a Monitoring Program for Critical Utilities Analytical Methods Validation Know Best Practices for Procedure and Method Transfers Perform Test Instrument and System Calibration Verifications Conduct Filter Validation in Dissolution Testing Medical Device Environment Design Engineering Studies, Protocols and Reports Implement Effective Software Validation Processes Develop and Maintain Effective Prospective and Retrospective Validations Novice to Advanced Professionals Discover a comprehensive validation and qualification guides to process, computer systems, equipment, and cleaning Move beyond the basics by attending advanced validation master classes Other Topics Covered Managing Contractors * Shipping Validation * Data Integrity Compliance * Process Start-Up Strategies * Pre-Qualification Documents * Perform Risk Assessments * Process Validation Lifecycle Approach* Sampling Plans * Design of Experiments * Continued Process Verification (CPV) Legacy Systems * Statistical Methods * Critical Quality Attributes (CQA) And Critical Process Parameters (CPP) * Change Management * Cloud Infrastructures * Excel™ Spreadsheets * E-Validation Solutions Personnel in the Following Environments Should Attend: Validation QA/QC Engineering Regulatory Affairs Compliance Manufacturing Laboratory This event is also appropriate to business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.
The Spencer Hotel
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