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This webinar will help you understand the industry background to the current transition to Risk-based Verification processes and the current trend in implementation by industry. You will learn the regulatory foundations, industry guidance, and primary components of risk-based verification as it relates to an overall specification, design, and verification program as outlined in ASTM E-2500-07; “Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment;” ASTM, 2007. Key implementation considerations and initial steps will be discussed.

Why Should You Attend:

Pharmaceutical manufacturing processes and other supporting operations are highly regulated by FDA current Good Manufacturing Practice (cGMP) regulations and other OUS regulatory agencies. Changes to existing commissioning, qualification and validation program practices that demonstrate compliance with these regulations are often avoided or rejected based on a perception of regulatory risk and potential negative impact to operations. This is especially true for significant changes, such as the current shift from ‘traditional’ practices to science-and risk- based practices.

This webinar will provide information illustrating that risk-based project delivery and verification processes as currently defined in industry standards and guidance documents are indeed aligned with current US and OUS regulatory expectations. This webinar will also present the System Life-cycle Model for Risk-based Asset Delivery and will discuss the interactions between the various activities in each phase of an asset delivery program. Finally, basic guidance on implementing Risk-based Asset Delivery processes will be presented and discussed.

Learning Objectives:

At the conclusion of this webinar, participants should be able to:

Identify the reasons why risk-based verification processes are currently being adopted in industry.
Identify the industry standards and guidance documents addressing Science- and Risk-based verification (and project delivery overall).
Understand the differences between a traditional Commissioning and Qualification program and a risk based verification program.
Describe the activities / phases in the System Lifecycle.
Describe the activities, phases, and supporting practices in the science- and risk-based process as defined in ASTM E-2500.
Identify key considerations for implementation.
Areas Covered in the Webinar:

This webinar will provide valuable assistance to all pharmaceutical industry companies in preparing for a transition to risk-based verification.

Why is this transition happening?
Asset delivery and verification processes need to respond to and address potential risks to patient safety and product quality.
Industry innovation
Streamlining the process
What is different about risk-based verification compared to traditional Commissioning and Qualification?
Product Quality and Patient Safety are the foundations
Verification activities traceable to product (Critical Quality Attributes)
Verification activities traceable to process (Critical Process Parameters)
Verification is interactive with the design process, not reactive to it
Verification as part of overall Risk-based asset delivery model
Includes appropriately conducted / documented vendor and engineering activities
Brief Overview of recent industry standards and regulations supporting science- and risk- based project delivery and verification processes
Overview of ASTM E-2500-7
Science- and Risk-based Asset Delivery Model
System Life-cycle Model
Requirements Definition
Specification and Design
Fabrication and installation
Acceptance and Release
Continuous Improvement
Supporting Practices
Vendor audits
Good Engineering Practice
Risk Assessments
Design Reviews
Engineering Change Management
Use of Subject Matter Experts
Key Considerations for Implementation
Determine what the desired outcome looks like
Process maps
Deliverables scope and content
Supporting processes and relationships
Identify key stakeholders who will need to approve implementation
Identify obstacles
Retain practices that work well, evaluate streamlining opportunities
Anticipate that most of the changes will likely involve Good Engineering Practice, Risk and Quality Management and Quality by Design principle implementation
Collaborate with successful implementers
Consider pilot implementation on small project scale
Who will Benefit:

This topic applies to personnel / companies in the Pharmaceutical and life sciences industry. The employees who will benefit most include:

Project Management
Commissioning and Qualification
Quality Assurance

Official Website:

Added by complianceonlinecom on November 7, 2012