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.