Special Pricing! $1,695 in-person or $1,295 virtual

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.

Over 50 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

Quality Risk Management

  • Develop a Custom Risk Analysis Tool
  • Use Product and Process Knowledge – CQAs & CPPs
  • Track Data and Monitor Outputs
  • Rank Risk and Filter for Risk Identification
  • Map Post-Market Events to Risk Analysis
  • Use Statistics as a Risk Management Tool

Change Control & Program Management

  • Conduct Meaningful Impact Assessments
  • Create Procedures, SOPs, Forms and Checklists
  • Present Your Program to an Inspector
  • Centralize Processes in a Global Organization
  • Validate and Document Automatic Software Upgrades
  • Integrate Risk Management into Processes

FDA Inspection Readiness

  • Build an Audit Team Based on Fitness-of-Use
  • Integrate Risk Management into Audit Programs
  • Conduct a Data Integrity Audit Enterprise-Wide
  • Inspection Readiness Conduct a Mock Inspection
  • Build Your Custom Audit Checklist
  • Bridge Communication Between Quality and Operations

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Quality Metrics Reporting Program

  • Measure Manufacturing Process Performance – Process Capability/Performance Indices, Lot Acceptance Rate (LAR), Right-First-Time Rate, Lot Release Cycle Time
  • Evaluate PQS Effectiveness – CAPA, Repeat Deviation Rate, Change Control, Equipment Effectiveness and Unplanned Maintenance
  • Optimize GMP Laboratory Performance – Adherence to Lead Time, Right-First-Time Rate, IOOSR, Calibration Timeliness
  • Ensure Supply Chain Robustness – On Time In Full (OTIF), Fill Rate, Disposition On Time, Days of Inventory On-Hand

21 CFR Part 211

  • Container and Closure Systems – Receipt and Storage, Testing and Approval, Approved Components, Retesting, etc.
  • Production and Control Processes – Written Procedures, Deviations, Calculation of Yield, Equipment Identification, Sampling and Testing, Contamination Control
  • Laboratory Controls – Testing and Release, Stability Testing, Special Requirements
  • Records and Reports – Equipment Cleaning, Master and Batch Records, Record Review, Lab and Distribution Records, Complaint Files

Statistics and Data Trending in Validation and Manufacturing

  • Accelerate Development of a Robust Control Strategy — Statistics in Process Development
  • Link Knowledge Across the Lifecycle & Optimize Sampling Plans to Demonstrate Process Performance – Statistics in PPQ: No More an Isolated Event
  • Design a CPV/OPV Program that Benefits the Patient and the Manufacturer
  • Tips & How to Avoid Common Mistakes Across the Lifecycle

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.