AGENDA
SPONSORS
VALIDATION UNIVERSITY COMES TO PUERTO RICO!
December 12 – 13, 2023
Attend in Puerto Rico or Virtually!
Join KENX for Validation & GMP University series tailored specifically for those manufacturing drugs, biologics, and medical devices in Puerto Rico. The event provides hands-on training for Quality, Validation, Engineering and Regulatory Affairs professionals. Participants create-their-own-experience by choosing from over 30 tutorials offering innovative, modern strategies for Validation and Quality Systems Management. Whether you’re interested in best practices for process, cleaning, and computer validations, or quality metrics, change control and risk management, this conference is for you! Come join the fun and learn from the best SMEs our industry has to offer and enrich your professional development in these critical environments.
30+ tutorials overflowing with rich content and tangible takeaways, including:
- Navigate the maze of validation regulatory guidance – A systematic approach to knowledge management
- Design a risk-based IQ, OQ, and PQ approach for facility commissioning & equipment qualification
- Modernize software validation – Align with CSA, risk assessments, and critical thinking
- Change Control – Mitigate risk when making changes to validated systems
- Continued Process Verification – Maintaining equipment and processes in a validated state
- Analytical testing for process validation
- Risk-based process validation – Program implementation case study
- QRM – Conducting a validation risk assessment
- Qualify critical utility systems – HVAC, Water and Gas
- Medical device validation & verification program implementation
- Build a Data Integrity program from the ground up
- Developing a high-quality Validation Master Plan (VMP) for regulators
- Risk-based supplier partnering and auditing – During the Pandemic and Beyond
- Minimize deviations and implement effective corrective actions
- Measure manufacturing process performance – Process capability/performance, Lot Acceptance Rate (LAR), Right-first-time rate, lot release cycle time
- Conducting impact assessments as part of change control
- Good documentation practice – Well written procedures, SOP’s, forms, and checklists
- Maximize your ROI on risk assessments – A practical, resource effective approach
- How to use risk throughout the process validation lifecycle
- Building and managing your audit team and design a custom checklist
- Bridging the communication gap between quality and operations
- Using statistics as a risk tool throughout the process validation lifecycle
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.
