Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies

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.

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

• Engineering
• Project Management
• Commissioning and Qualification
• Quality Assurance
• Regulatory Affairs
• Manufacturing and Operations

Instructor Profile:

Mr. Franklin, has over 24 years of experience and leadership supporting planning and delivery of major capital assets. Specific areas of expertise include planning, development and execution of Commissioning & Qualification (C&Q), Preventive Maintenance planning and delivery, Project Information Mgt., and approaches reflecting the ASTM E2500 Standard. He is experienced in facility startup and in all stages of C&Q programs; including strategy & planning, development, execution, and delivery. He is a contributing author to the new ISPE Baseline Guide #12 on Specification, Design and Verification and to the ISPE C&Q Good Practice Guide. Mr. Franklin is a veteran of the United States Army and a graduate of Lewis University with a Bachelor’s degree in Aviation Maintenance Management followed by a Master of Business Administration from National University.

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