Validation University 2019

Knowledge Exchange Network (KENX) has announced that their Validation University (Val-U) is returning to Cork, Ireland on 25-27 November, offering hands-on training for the biotech, medical device, pharmaceutical and related industries.

Professionals of C&Q, engineering, quality, validation and more will be able to choose from over 50 tutorials and benefit from the extensive knowledge and useful material the faculty exchanges. Val-U is comprised of three conferences and offers hands-on experience, which can turn lessons learned into immediate, actionable results.

Computer System Validation (CSV) & Data Integrity Inspection Readiness

Tutorials within this conference comprise of those exploring CSV and include Cybersecurity – Addressing Malicious Threats to the Life Science Industry, Master the Key Components to Build and Maintain an Inspection-Proof Programme, Discover a GDPR-Compliant Approach for SAAS, IAAS and Other Software Services and Develop an IT Infrastructure and Network Qualification Roadmap.

Areas within Data Integrity Compliance will also be explored and include tutorials such as: Construct a Programme from the Ground Up, Prepare for and Perform a Data Integrity Audit, See Remediation Projects and How to Build for the Future and Know How to Respond to Data Integrity Inspection Findings.

Process Validation & Continued Process Verification

As part of this conference, tutorials on Commissioning & Qualification will take place and include: 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 and Qualify Temperature Mapping and Storage Chambers.

Tutorials on Process Validation will also occur throughout the event and comprise of: Learn How to Use Statistics in Validation – Statistics for Non-Statisticians, Implement a 3-Stage Process Validation Approach, Master the Validation Master Plan (VMP) and Conduct Risk-Based Revalidations and Periodic Reviews of Validated Systems.

Cleaning Validation & Critical Cleaning Processes

Seminars within the Cleaning Validation conference that will be taking place consist of: Understand Key Elements to a Successful Programme, Establish Cleaning Residue Limits and Acceptance Criteria, as well as Establishing Bioburden and Endotoxin Limits for Sterile and Non-Sterile Products and Processes and Receive a Cleaning Validation Assessment Checklist Example.

Hear from Industry Experts

Throughout the event, connect with a large number of industry experts who will be able to share innovative processes that can keep businesses fully compliant over a long-term period.

Experts such as Connie Hetzler, Global Head of Validation at Alcon Laboratories, Roland O’Mahony, Technical Operations Manager at Janssen Sciences and many more will be in attendance.