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IPS is a Gold Sponsor for the KENX Validation & GMP University Hybrid Conference taking place in Philadelphia, PA.

Join KENX for hands-on training for engineering, quality, C&Q, and validation professionals within the pharmaceutical, biotech, medical device, and related industries. Participants can create their own experience by choosing from over 55 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 to turn into immediate, actionable results.

55 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe
 
Facility Commissioning & Equipment Qualification

  • Implement a Risk-based Verification Strategy
  • Design a Risk-based IQ, OQ, and PQ Approach
  • Manage Process Validation Tech Transfers
  • Qualify Critical Utility Systems – HVAC, Water and Gas

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 Continued Process Verifications

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

  • Stay up to speed with FDA’s Computer Software Assurance proposed draft
  • Implement a Risk-Based CSV Program Enterprise-Wide
  • Develop and Validate SAAS, IAAS, and Other Software Programs
  • Qualify Network Infrastructure and Cloud Environments

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.

Find more information here.

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