Commissioning, Qualification & Validation University 

Making the life science industry a safer place…and loving every minute of it! We have spent the past three decades on an epic ride through the life science industry. With early beginnings in the FDA and globally-regulated environment, we understand the importance of exchanging knowledge to make drugs and devices safer, and equipment and processes more scientifically sound. In the end, exchanging knowledge not only improves lives, but also saves them. Whether you attend one of our interactive conferences or webinars, or take advantage of our valuable free process documents; our goal is to provide tools and techniques that will have an instant impact on your core responsibilities.

Knowledge Exchange Network

<H3>VALIDATION UNIVERSITY RETURNS TO DUBLIN!</H3>
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
<UL>
<LI>Implement a Risk-based Verification Strategy</LI>
<LI>Harness Product and Process Knowledge to Drive a Risk-based IQ, OQ, and PQ Approach</LI>
<LI>Manage a Large CQV Project as Part of a Tech Transfer to an Existing Facility</LI>
<LI>Qualify Temperature Mapping and Storage Chambers</LI>
</UL>
 
Process Validation
<UL>
<LI>Learn How To Use Statistics in Validation – Statistics for Non-Statisticians</LI>
<LI>Implement a 3-Stage Process Validation Approach</LI>
<LI>Master the Validation Master Plan (VMP)</LI>
<LI>Conduct Risk-based Revalidations and Periodic Reviews of Validated Systems</LI>
</UL>
 
Cleaning Validation
<UL>
<LI>Understand Key Elements to a Successful Program</LI>
<LI>Establish Cleaning Residue Limits and Acceptance Criteria</LI>
<LI>Establishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes</LI>
<LI>Receive a Cleaning Validation Assessment Checklist Example</LI>
</UL>
 
Computer System Validation
<UL>
<LI>Cybersecurity – Addressing Malicious Threats to the Life Science Industry</LI>
<LI>Master the Key Components to Build and Maintain an Inspection-proof Program</LI>
<LI>Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services</LI>
<LI>Develop an IT Infrastructure and Network Qualification Roadmap</LI>
</UL>
 
Data Integrity Compliance
<UL>
<LI>Construct a Program from the Ground Up</LI>
<LI>Prepare for and Perform a Data Integrity Audit</LI>
<LI>See Remediation Projects and How to Build for the Future</LI>
<LI>Know How to Respond to Data Integrity Inspection Findings</LI>
</UL>
 
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
 
 
<H3>Personnel In The Following Environments Should Attend:</H3>
<UL>
<LI>Validation</LI>
<LI>QA/QC</LI>
<LI>Engineering</LI>
<LI>C&Q</LI>
<LI>Regulatory and Compliance</LI>
<LI>Facility Management</LI>
<LI>Manufacturing</LI>
<LI>Laboratory</LI>
</UL>
 
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.

The Spencer Hotel

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