HYBRID CONFERENCE & SPEAKER: KENX Validation University

SAVE $200 off your registration with CODE: Novatek200 

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 Verfications

 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