ATTEND VIRTUALLY OR IN PERSON
October 9-10 | San Diego
San Diego Marriot La Jolla
4240 La Jolla Village Drive, La Jolla, CA 92037
AI in QMS Session Highlights:
- Use GenAI Responsibly in Validation and Technical Documentation
- AI-Powered Risk Management & Intelligent QMS Insights
- AI in QMS: Otsuka’s Strategy for Secure, Compliant GenAI Adoption
- AI Predictive Maintenance for GMP Environments
- Validate Adaptive AI Algorithms in SaMD and Smart Devices
- Modernizing Legacy Systems: Moving into the AI Fold
- AI and Quality Systems – Building Trust in a Digital Era
GMP Hot Topics
- Top Five Risk Management Mistakes and How to Avoid Them
- Building a Change Control Framework That Survives Inspection Scrutiny
- Quality Metrics and KPIs: What Regulators Really Expect
- Data Integrity Across the Product Lifecycle
- Developing a Site Preparation Strategy for a Successful FDA Inspection
- Using Statistics and Analytics as Risk Management Tools
Do you need a team discount?
Save $300 per ticket when you register 4 or more!
Contact Howard Wilensky to answer your registration questions and access exclusive team discounts.
SCHEDULE HERE
SCHEDULE HERE
Early Bird Pricing Until September 5
Single Admission – Manufacturer and Temple: $1,795 ($1,995)
Single Admission – Solution Providers: $1,995 ($2,195)
Single Admission – Solution Providers: $1,995 ($
Complimentary Webinar
Preparing for GMP Inspections:
What Regulators Are Looking For
July 23, 2025
11:00AM – 12:15 PM EST
Moderated by:
David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
What You’ll Gain:
- Comprehensive understanding of current GMP inspection expectations
- Strategies to maintain a state of control and continuous compliance
- Insights into effective documentation practices that tell your quality story
- Techniques for training personnel to confidently engage with inspectors
- Awareness of common inspection pitfalls and how to proactively address them
- Best practices for managing both scheduled and unannounced inspections
Who Should Attend:
- Quality Assurance and Quality Control professionals
- Regulatory Affairs specialists
- Manufacturing and Operations Managers
- Compliance Officers
- Training and Development Coordinators
- Anyone involved in GMP compliance and inspection readiness
