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Commissioning, Qualification & VALIDATION UNIVERSITY

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Master Planning * Risk * Statistics * Change Control * Documentation * CPV

November 19 - November 21

Dublin, Ireland

Val – U for Process * Cleaning * Computer Systems * Equipment * Utilities * Facilities * Data Integrity 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 38 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.  

 

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

 

Commissioning & Qualification

  • Implement a Lean, Risk-Based Verification Approach
  • Identify Nonconformances and Improve Outcomes
  • Conduct Compliant Utility Qualification Processes
  • Understand New System URS & Qualification Processes (DQ, IQ, OQ, PQ)

 

Process Validation

  • Master Critical Elements Including Statistical Sampling Plans
  • Establish Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)
  • Implement a Compliant Continued Process Verification (CPV) Programme
  • Manage Variability by Using Design of Experiments (DoE)

 

Cleaning Validation

  • Examine Health-Based Cleaning Limit Formulas
  • Establish Acceptance Criteria and Set Active Ingredient Limits
  • Resolve Issues and Deviations During Protocol Execution
  • Implement a Risk-Based Approach & Understand Critical Processes

 

Computer System Validation

  • Master A Life Cycle Approach and Implement Enterprise-Wide
  • Qualify Cloud Infrastructures and Mobile Devices
  • Perform a Part 11 Gap Assessment
  • Conduct a Functional Risk Assessment (FRA) on a Complex System

 

Data Integrity Compliance

  • Ensure Governance Throughout the Life Cycle
  • Learn how to Conduct Risk Assessments and Investigate Root Causes
  • Prepare for and Handle Investigators in a Regulatory Audit
  • Implement System Safeguards and Controls

 

LEADING ORGANIZATIONS SHOWCASING BEST-IN-CLASS INNOVATION AND PROCESSES, INCLUDING:

Agidens Life Sciences * Bausch + Lomb * Bayer * BioMarin * Bio Products Laboratories * Bristol-Myers Squibb * Commissioning Agents, Inc. * Dublin Institute of Technology * ICQ * Odyssey VC * Rescop * Sanofi * Shire * ValGenesis * Validant * VTI Life Sciences * Medicines & Healthcare Products Regulatory Agency (MHRA)

 

RECEIVE OVER 2 DOZEN TEMPLATES, TOOLS, SOPS, CHECKLISTS AND OTHER USEFUL TOOLS, INCLUDING:

Risk Based Verification Process Flow * Lifecycle Verification Plan IOQ Report * Commissioning Document (with Lean Approvals) * Process Risk Assessment * Test Scripts and User Requirements * IOQ Protocol * PQ Protocol * Monitoring Plan * Cleaning Validation Periodic Review * Cleaning Validation Protocol * Data Integrity Checklist * URS Process Flow and Responsibilities * IQ/OQ Infrastructure * DoE Protocol

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 to business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the lifescience environment.

Agenda

More Information To Follow Soon

Faculty

  • COMING SOON!

Sponsors

  • GOLD


  • Ellab

    Providing the world's leading life science and food companies with high quality thermal process validation and monitoring solutions
    Website: http://www.ellab.com
  • Kneat Software

    Digitally Transforming GxP Validation Processes
    Website: http://kneat.com
  • SILVER


  • Novatek

    Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.
    Website: http://ntint.com/
  • ValGenesis

    Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • VTI Life Sciences

    Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

Venue

Details

Start:
November 19
End:
November 21
Event Category:

Venue

Dublin
Dublin, Ireland + Google Map

Pricing & Registration

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