Validation & GMP University








BTR

CAI






VALIDATION & GMP UNIVERSITY

Attend Virtually or In-Person

August 23-25, 2021 | Philadelphia, PA

Special Team Rate: $1,500 per attendee for a team of 4

Agenda at a Glance

VALIDATION & GMP UNIVERSITY

August 23rd – 25th

Take Advantage of Early Bird pricing through July 16th! 


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 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 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

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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