March 28 – 30, 2023
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.
Join KENX at industry’s validation event of the year! Whether you’re in QA, validation, or engineering; a novice or advanced professional; or, attending in-person or online, this is your chance to network with over 200 of like-minded colleagues in the FDA-regulated environment.
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
- 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
- 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
- Modernize CSV Programs with FDA’s New CSA Guidance
- Implement a Risk-Based CSV Program Enterprise-Wide
- Develop and Validate SAAS, IAAS, and Other Software Programs
- Qualify Network Infrastructure and Cloud Environments
Advanced Validation Practices
- Applying Quality Metrics to Validation
- Critical Thinking – Understand How to Develop Critical Thinking Skills
- ICH Q10 Pharmaceutical Quality System, Section 2 – Mastering Management Responsibilities
- Continuous Process Validation and Holistic Control Strategy – Thinking Beyond CPP-Based Critical Aspects
Interested in attending specific advanced sessions? Click here for our brochure.
Personnel In The Following Environments Should Attend:
- Regulatory and Compliance
- Facility Management
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.
Early Bird Pricing Ends March 3rd, 2023!
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email firstname.lastname@example.org, Call 856-281-7134 or Register using the Temple Track Ticket above.
“This is the first time I am attending a Virtual Conference, Love how interactive it is and also the Whova app is great.”
CSV Manager, Meitheal Pharmaceuticals, Inc.
“Great presentations, speakers, and interaction by both onsite and remote participants. Whova has been the best virtual conference platform I’ve experienced over the past few years.”
-ISO IT CSV and SQA Manager, AmerisourceBergen