VALIDATION UNIVERSITY RETURNS TO DUBLIN!

Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning to Ireland this fall. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create their own experience by choosing from over 40 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.

40 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

Commissioning & Qualification

• Implement a Risk-based Verification Strategy
• Harness Product and Process Knowledge to Drive a Risk-based IQ, OQ, and PQ Approach
• Manage a Large CQV Project as Part of a Tech Transfer to an Existing Facility
• Qualify Temperature Mapping and Storage Chambers

Process Validation

• Learn How To Use Statistics in Validation – Statistics for Non-Statisticians
• Implement a 3-Stage Process Validation Approach
• Master the Validation Master Plan (VMP)
• Conduct Risk-based Revalidations and Periodic Reviews of Validated Systems

Cleaning Validation

• Understand Key Elements to a Successful Program
• Establish Cleaning Residue Limits and Acceptance Criteria
• Establishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes
• Receive a Cleaning Validation Assessment Checklist Example

Computer System Validation

• Cybersecurity – Addressing Malicious Threats to the Life Science Industry
• Master the Key Components to Build and Maintain an Inspection-proof Program
• Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services
• Develop an IT Infrastructure and Network Qualification Roadmap

Data Integrity Compliance

• Construct a Program from the Ground Up
• Prepare for and Perform a Data Integrity Audit
• See Remediation Projects and How to Build for the Future
• Know How to Respond to Data Integrity Inspection Findings

FEATURED REGULATORY KICKOFF

MHRA Releases Data Integrity Final Guidance

Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, MHRA

Change Control and Risk Reduction – Two Sides of the Same Coin?

Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA

PLUS! Receive Tips from MHRA and HPRA on Handling Regulatory Inspections – Observe Tracy and Kevin Participate in a Mock Inspection

Personnel In The Following Environments Should Attend:

• Validation
• QA/QC
• Engineering
• C&Q
• Regulatory and Compliance
• Facility Management
• Manufacturing
• Laboratory

This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.