Process validation is a powerful technique to help you find the point where your process should operate. In addition, it can help you find the limits of the process. These limits, applied to the process inputs define the parameter space that produces satisfactory process output.

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 have requirement for process validation. The webinar explains the requirements to help you implement them. It also illustrates problems with FDA Warning Letters.

The webinar will explain the current state of the FDA's guidance documents as well the GHTF guidance document.

Why you should 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. Understanding the FDA's thinking for devices is important.

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!

• Can you list the processes that produce product, including intermediate products, in your production stream?
  
• Can you state how you verify each process output, i.e., the inspections and tests that demonstrate conformity?
  
• Do you know which verifications are destructive?
  
• If verification is done with sampling, can you state the probability of not finding all the nonconformities?
  
• Do you know the operating point of each process?
  
• Do you know the challenge points of each process?

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
• Writing the protocol
• 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: 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