Fundamentals of Process Validation

Why Should You Attend:
Process validation, or the lack of it, is coming under close scrutiny by the FDA. It has been the subject of Warning Letters over the past few years. In addition, the FDA’s approach is changing. Instead of one common validation approach, the FDA Centers have started to go in different directions. Most likely, the FDA’s CDRH will follow the Global Harmonization Task Force (GHTF) guidance. Last, an effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the nonconforming material.

Your Quality Management System (QMS), should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

This webinar defines the concepts, using diagrams, to help you understand the principles of process validation. It divides process validation into three phases: Installation Qualification, Operational Qualification, and Production Qualification. The seminar explains how to develop protocols for each phase and write reports that document the work.

In addition, the webinar explains the regulatory requirement for process validation ,both FDA’s QSR and ISO 13485. We will examine some FDA Warning Letters to help understand the requirements and explain the current status of the FDA and GHTF Guidance Document as it relates to medical devices.

Learning Objectives:

• Understand the business value of process validation.
• Explain how process validation support Risk Management.
• State the FDA requirement that tell when a process must be validated.
• State the ISO 13485 for requirement for process validation.
• Explain the current state of the FDA Guidance documents.
• Describe the role of the GHTF Guidance document.
• State the phases of process validation.

Areas Covered in the Seminar:

• The Concepts Of Process Validation
  • Why it is a Good Practice
  • Verification and Validation Explained
  • The Diagram for the Parameter Space
  • Process Validation and the Links to Risk Management
• Regulatory Requirements
  • FDA’s QSR (21 CFR 820.§75)
  • ISO 13485:2003 Clause 7.5.2
• Guidance Documents
  • The FDA’s changes to Process Validation Guidance
  • The GHTF Guidance Document
• Installation Qualification (IQ)
• Checklist
• Considering OSHA regulations
• Considering OSHA regulations
• Writing the report
• Operation Qualification
• Checklist
• What this phase accomplishes
• Writing the protocol
• Writing the report
• Production Qualification (PQ)
• Checklist
• What this phase accomplishes
• Writing the protocol
• Writing the report

Who Will Benefit:

This seminar is designed for people involved in production, validation, and verification activities. Attendees should understand the concepts of processes and their interactions. Knowledge of SPC and designed experiments will be useful, but is not required.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Professionals
• Regulatory Professionals
• Production Managers
• Risk Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners

Instructor Profile:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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