$1,721.25 – $2,295

Commissioning, Qualification & Validation University Philadelphia

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Wyndham Philadelphia Historic District

400 Arch Street

Philadelphia, PA 19106

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VALIDATION UNIVERSITY HEADS TO PHILADELPHIA!

Knowledge Exchange Network (KENX) is very excited to announce their Commissioning, Qualification & Validation University heads to Philadelphia this spring. 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.

50 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

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.

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Wyndham Philadelphia Historic District

400 Arch Street

Philadelphia, PA 19106

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