HYBRID CONFERENCE
VENUE
The DoubleTree by Hilton or attend virtually
237 s Broad Street, Philadelphia, Pennsylvania
GMP University
Are you a life science professional in charge of ensuring your firm is compliant with GMPs throughout the Pharmaceutical Quality System? Are you up-to-speed in 21 CFR Part 211 regulatory expectations and compliance trends? Did you know FDA renewed their interest in Quality Metrics by asking for public comments suggesting an FDA guideline is moving forward? Would you like to understand GMP statistics and data trending to use risk and deviation tool? Are you still having issues with Data Integrity? If your answer is yes, don’t walk – run to this event to keep you up-to-the-minute with GMP regulations and compliance trends, best in class procedures/documentation and the innovative technology platforms to get you there.
Who 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.
BONUS! Choose Between Two Pre-conference Workshops
1) QRM- ICH Q9 Revision 1 Update – Review, Impact to the Industry and
Implementation
presented by: Steven Thompson, Director Industry Solutions, ValGenesis
2) Building a GMP Training from The Ground Up
presented by:Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics
& Dori Gonzalez-Acevedo, CEO, ProcellaRX
Don’t Miss Our Pre-Sale Deadline Through June 9th ($995)
CREATE YOUR OWN EVENT – 6 TRACKS with 45+ SESSIONS!
HIGHLIGHTS INCLUDE:
QUALITY RISK MANAGEMENT
- Maximize your ROI on Risk Assessments – A Practical, Resource Effective Approach
- How to Use Risk Throughout the Process Validation Lifecycle
- Successful FMEA Training and Continual Improvement
- Learn How to Create and Use a Customized Risk Tool
CHANGE CONTROL PROGRAM MANAGEMENT
- Conducting Impact Assessments as Part of Change Control
- Integrate Risk Management into Change Control Procedures
- Good Documentation Practice – Well Written Procedures, SOP’s, Forms, and Checklists
- Change Control for Computer Systems and Software Upgrades
AUDITS & INSPECTIONS
- Building and Managing Your Audit Team and Design a Custom Checklist
- Learn Best Practices for Conducting Mock Audits
- Bridging the Communication Gap Between Quality and Operations
- Preparing Your Firm for an FDA Inspection
QUALITY METRICS
- Learn Effective Strategies to Ensure Supply Chain Robustness
- Measure Manufacturing Process Performance – Process Capability/Performance, Lot Acceptance Rate (LAR), Right-First-Time Rate, Lot Release Cycle Time
- Equipment Effectiveness and Maintenance – The Good, The Bad and The Unexpected
QUALITY SYSTEMS MANAGEMENT
- Best Practice for Handling Testing and Production Batch Records
- Risk-based Supplier Partnering and Auditing – During the Pandemic and Beyond
- SOPs – Writing Quality Procedures that Survive the Lifecycle
- Minimize Deviations and Implement Effective Corrective Actions
STATISTICS IN VALIDATION
- Moving to Objective, Data-Driven Decisions
- Using Statistics as a Risk Tool throughout the Process Validation Lifecycle
- Optimize Sampling Plans to Demonstrate Process Performance
- Use Statistical Analysis for Setting Acceptance Criteria
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.
