Process Validation for Medical Devices: 2-day In-person Seminar

Medical device manufacturers can avoid FDA Warning Letters, 483s and enforcement actions with a good understanding process validation principles. But knowing how to proceed is the toughest task as no FDA guidance document is available which talks about it.

This two day interactive seminar is designed to make you understand the regulatory requirements of both FDA QSR and ISO 13485:2003. To compensate for the missing guidance document, the course draws the “how to” answer from various other sources including the GHTF guidance, FDA’s QSIT, FDA Warning Letters, and the guidance document for ISO 13485:2003. This course will help attendees understand the regulatory requirements and the statistical methods needed to perform effective process validation for medical device manufacturing.

During this two day seminar the instructor will focus on:

• Regulatory requirements from FDA QSR and ISO 13485:2003
• How to use process validation forISO 14971:2007 risk reduction
• How to apply corrective action properly in solving problems
• How process validation supports the production and process control requirements of QSR
• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) techniques and their application in process control
• ApplicableOSHA regulations, Hazard Analysis and Critical Control Point (HACCP)to ensure a robust system
• The relationship between “validated with a high degree of assurance” and process capability indices
• How to usedesign of experiments (DOE)to define the input parameter space, an essential element of Operational Qualification

• Learn the three elements of FDA QSR’s approach to process validation
• Understand and apply the traditional phases of process validation: IQ, OQ, and PQ
• Be aware of the regulatory issues and how an FDA Investigator approaches process validation
• Review and analyze Warning Letters to avoid common problems
• Integrate process validation with risk management including risk reduction and production information collection
• Incorporate HACCP methodology to help improve your process
• Learn the statistical basis for process validation and apply the methods
• Develop designed experiments to explore the parameter space and set limits