Risk-Based EM Sampling Strategy -
Using the Process Risk Control Strategy to
Determine EM Sampling Strategy

August 11th, 2021 11:00 AM – 12 PM SST

August 10th, 2021 11:00 PM – 12 AM EDT

Part 1 – Holistic Process Risk Control Strategy
• Process Risk Assessment and establishing a holistic risk
control strategy
• Environmental risks and risk controls

Part 2 – Environmental CQAs and CPPs
• Environmental CPPs and the product CQAs impacted
• ISO classifications and regulatory requirements

Part 3 – Environmental Monitoring Strategy Prerequisites
• Risk-based process-related prerequisites
• Risk-based product-related prerequisites
• Risk-based facility-related prerequisites
• Risk-based equipment-related prerequisites
• Operational prerequisites

Part 4 – Environmental Monitoring Risk Assessment
• Identify appropriate SMEs (Validation, Engineering, QC)
• Understand the EM Risk Assessment process
• Understand EM Risk Assessment criteria
• Determine EM sampling types, locations, and frequency


Chip Bennett

Associate Director,
Global C&Q, SME, CQV Program
Development, QRM, CAI

Chip Bennett, Assistant Director, Global C&Q, CAI is a QRM SME and lead CQV Program Development SME. A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.