IVT’s Quality Metrics & Management Week - SOLABS
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IVT’s Quality Metrics & Management Week

- 5 January 2016



2016-02-22 9:00:00
2016-02-24 18:00:00
America/Los_Angeles
IVT’s Quality Metrics and Management Week
IVT’s inaugural event, Quality Metrics and Management Week, combines our annual change control and risk management events to provide you and your team a platform for creating a culture of continuous improvement and innovation enterprise-wide.
Coronado Island, San Diego, CA
ITV
info@solabs.com

THREE CRITICAL TASKS — ONE CHOICE FOR EXCELLENCE
QUALITY METRICS • CHANGE CONTROL • QUALITY RISK MANAGEMENT

IVT’s inaugural event, Quality Metrics and Management Week, combines our annual change control and risk management events to provide you and your team a platform for creating a culture of continuous improvement and innovation enterprise-wide.

FDA’s CDER and CBER recently released a draft guidance on Quality Metrics that is going change the face of quality units in pharmaceutical manufacturing. This data-driven initiative requires measurement of lot acceptance rates, product quality complaint rate, invalidated OOS results, Annual Product Review (APR) on Time Rate, and other “optional” metrics related to quality culture and process capability/performance.

It is critical that quality units stay ahead of the curve on this important guidance.

24 Cutting-Edge Sessions, including:

• Integrate Quality Metrics in Your Process Validation Program
• Hear Proctor & Gamble Outline Their Quality Metrics Pilot Program
• Link Quality Metrics to Individual Performance Incentives
• Learn Documentation Strategies for the New Quality Metrics Guidance
• Implement CAPA Adhering to the QM Initiative
• Use Statistical Process Control (SPC) as a Tool for Understanding and Managing Variability
• Conduct a Gap Analysis of Your Change Control Program
• Implement Change Control into Your Process Validation Program
• Define Risk and Risk Levels — Implement ICH Q9 Quality Risk Management
• Perform a Risk-based Impact Assessment
PLUS! CHOOSE BETWEEN THREE IN-CONFERENCE WORKSHOPS

Design, Implement and Sustain Enterprise-wide Quality Metrics for Biopharmaceuticals and Devices

CASE STUDY

• Introduction to Quality Risk Management (QRM) Implementation
• Create an Effective Change Control Program for Your Organization
ELITE INDUSTRY PERSPECTIVES

Stanley Bouma, Ph.D., Senior Project Manager, Risk Management, Abbott Molecular

Pete Buckwalter, Global Head IT Quality, Compliance & Risk Management, MedImmune

Jack C. Chu, PE MBA, Associate Director of Engineering, MMD-WP, Merck & Co. Inc

Rod Freeman, Manager, Validation and Calibration – Carlsbad Reagent Manufacturing Global Process Owner – Process Validation, Beckman Coulter

Steve Greer, Corporate QA External Engagement Leader, Procter & Gamble

Alan Golden, M.S., Quality Consultant Operations Support, Abbott Molecular

Mehron Mirian, B.S, Quality Assurance-Validation Manager, B. Braun Medical, Inc.

Jayme Richter, BA, Quality Assurance-Validation Manager, B. Braun Medical, Inc.