Earn 1.5 credit unit hours by registering for this course!

By taking this on-demand course, you’ll be able to earn 1.5 credit unit hours.  Once registered, KENX will send your log-in to our virtual conference which contains the designated Temple University sessions. 

Take every designated Temple session on your time, the schedule is completely up to you!

You can also earn credits through our other courses such as Laboratory University and CSV & DI Compliance Congress.

VALIDATION UNIVERSITY

Missed Validation & GMP University?
No problem!

For a limited time, you can purchase the on-demand conference!

Access to all 55+ sessions
Watch any and every session you’ve checked off on your agenda. Access to the recorded sessions will be available until
September 25, 2020.

3,000 pages of content!
You will also receive the conference compendium with over 3,000 pages of fresh content, including all PowerPoint presentations, SOPs, checklists, master plans and more! Please note that the compendium can be viewed indefinitely after the event.

Once you purchase your ticket, you will receive a login to the on-demand conference site!

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 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.

This Conference is Co-Located with DATA INTEGRITY INSPECTION READINESS SUMMIT with In-Depth Coverage On:

• Understand the Human Factor for Compliance
• Learn How to Build a Program from the Ground Up
• Identify the Root Cause of Inaccuracies
• Conduct an Audit/Gap Assessment and Implement Corrective Action
• Comply Across the GxP Environment
• Benchmark With Manufacturing, Laboratory and Clinical Top Companies
• Address Malicious Threats through Cybersecurity Best Practices
• Conduct Data Integrity Risk Assessments
• Know How to Handle Audit Trails