Course Description:

Warning Letters for process validation are becoming more common. In 2015, for example, almost 30% of the Warning Letters for QSR included process validation as one of the cited areas. These problems cover a range of issues such as lack of procedures, not following the procedures, documentation issues, statistical problems, and failure to manage the process input parameters.

Device manufacturers could avoid these troubles, and the Warning Letters, with a solid understanding of the principles of process validation. FDA does not have a guidance document on medical device process validation, so manufacturers are often unclear about how to proceed.

This course ensures you understand the regulatory requirements from both FDA QSR and ISO 13485:2003. To compensate for the lack of FDA guidance, the course draws on a variety of other sources including the GHTF guidance, FDA’s QSIT, FDA Warning Letters, and the guidance document for ISO 13485:2003.

This course helps design engineers, production engineers, quality engineers, and production people understand the regulatory requirements and the statistical methods needed to perform an effective process validation for medical devices. After validating the process, the manufacturer operates the process, collects information, and creates quality records.

Process validation is an integral part of the Quality Management System (QMS) and the Risk Management System (RMS) so the course covers those relationships. You will learn how to use process validation for ISO 14971:2007 risk reduction, apply corrective action properly in solving problems, and understand how process validation supports the production and process control requirements of QSR.

While not a regulatory requirement, the course uses the traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) model. You will understand this common approach and the application of these traditional phases.

At its fundamental, however, process validation is applied statistics. You will learn the relationship between “validated with a high degree of assurance” and process capability indices. The course explains the use of design of experiments to define the input parameter space, an essential element of Operational Qualification.

This highly interactive course provides many examples and exercises that will help you explore the subject and solidify your learning.

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Why Should You Attend:

Manufacturing companies, especially medical device manufacturers, must determine when a process requires validation. For these processes the manufacturer must plan the validation, perform it following the plan, and operate it following the procedures and work instructions.

This workshop gives you the skills, practical knowledge, and tools for these critical tasks.

Areas Covered in the Session:

  • The three elements of the FDA QSR approach to process validation
  • The traditional phases of process validation: IQ, OQ, and PQ
  • The regulatory issues and how an FDA Investigator approaches process validation
  • Review and analysis of Warning Letters to avoid common problems
  • Integration of process validation with risk management including risk reduction and production information collection
  • The statistical basis for process validation
  • Application of statistical methods including designed experiments

Who will Benefit:

This course develops the methodology required for effective process validation. Because it covers both the regulatory and statistical aspects, the course appeals to a variety of skills and disciplines. Among them are:

  • Quality Engineers
  • Production Engineers
  • Design Engineers
  • Risk Management Specialists
  • Production Managers
  • Production Supervisors

Course Outline:

Day One (8:30 AM – 5:00 PM) Day Two (8:30 AM – 5:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Process Validation Concepts
    • When to validate a process
    • Contrasting process output verification and process validation
    • The regulatory definitions of process validation
  • The Requirements Framework
    • The FDA QSR requirements
    • The ISO 13485:2003 requirements
    • Using the guidance document on ISO 13485:2003
    • Using the GHTF guidance document for complete understanding
  • The Regulatory Approach
    • What the FDA Investigator looks for
    • Using QSIT to help ensure compliance
    • Warning Letters – Learning from others
  • Installation Qualification
    • Equipment placement
    • OSHA standards and how they impact equipment
    • Maintenance and calibration from FDA QSR
    • Maintenance and calibration from ISO 13485:2003
    • Developing checklists

  • Statistical Methods (Part 1)
    • Process Capability
    • Acceptance Sampling
    • Statistical Process Control
  • Statistical Methods (Part 2)
    • Factorial Design of Experiments (DOE)
    • Transmission of Variation
    • Robust Tolerance Analysis
  • Operational Qualification
    • Exploring the parameter space with DOE
    • Setting control limits and action levels
    • Running Challenge Tests
  • Performance Qualification
    • Defining controlled conditions
    • Evaluating Deviations
  • The Process in Production
    • Monitoring process parameters
    • Data collection
    • Integration with Risk Management

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

He is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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