A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 25th Year of Publication

Quality

Advanced Process Validation For Medical Device Manufacturers

Background : Due to the complexity of many medical devices, routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of the device or its components.

With a focus on in-depth process validation methods and statistical rigor, this four-day advanced session will explain the intent and importance of process validation with respect to the regulations and standards, emphasizing the connectivity between design controls, risk management and statistical techniques. The training will also provide participants the fundamental knowledge and tools to establish and implement effective process validation lifecycle systems. Hands-on, interactive exercises will highlight and reinforce the principles learned.

Objectives :

  • Understand the intent and purpose of regulations as it applies to process validation and production controls

  • Know how design controls and risk management feed into process validation

  • Learn the fundamentals of Test Method Validation and Measurement Systems Analysis

  • Learn to identify which processes to verify and which process to validate

  • Be able to develop a Master Validation Plan

  • Learn to calculate basic quality metrics and determine sample sizes

  • Learn to use statistical methods like design of experiments (DOE) to determine critical process and raw material parameters

  • Learn the principles of Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) using protocols and reports

  • Understand the basics of risk management and developing a Process Failure Mode and Effects Analysis (PFMEA)

  • Identify key outputs from process validation

  • Learn to formulate methods for process monitoring and control

  • Understand the concepts of statistical process control (SPC) and statistical quality control (SQC)

  • Understand how to maintain the validated state and the criteria for revalidation

Test Method Validation

Background : Test methods are one of the most critical elements in the design, development, manufacture and release of products. They provide the objective evidence for the safety and effectiveness of devices. It is thus imperative that device manufacturers ensure their test methods used in the determination of safety and effectiveness for their product are suitable, capable and reliable for their intended use. Inadequate test method validation can have severe regulatory and business consequences. In the past few years, regulatory bodies have added additional focus on test method suitability and reliability in their audits and inspections.

This two-day session will explain the intent and importance of test method validation with respect to the regulations and standards. The training will also provide participants the fundamental knowledge and tools to establish and implement effective test method validation procedures and processes. Hands-on, interactive exercises will be used to highlight the principles learned.

Objectives :

  • Understand the intent and purpose of regulations as it applies to test methods across the product lifecycle
  • Learn the basic principles of Test Method Validation to determine suitability and capability of the test method for its intended use
  • Understand the requirements for the qualification of test equipment
  • Understand requirements for calibration
  • Understand how to conduct a gauge repeatability and reproducibility (Gauge R&R) for variable data and attribute data
  • Learn the principles of method transfer
  • Lear how to develop and complete test method protocols and reports
  • Understand the validation life-cycle and changes to test methods

The Links For the Above Two Training Programs :

• Advanced Process Validation Training, May 16-19,2017, Chicago IL

http://winovia.com/advanced-process-validation/

• Test Method Validation Training, July 18-19, 2017, Chicago, IL

http://winovia.com/test-method-validation/

 

 

Back | Back To Top