Test Method Validation Training

Course Description

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.

Learning 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

Who will benefit

• Development engineers
• Testing labs managers, engineers and technicians
• Quality assurance and quality control
• Research and development managers and engineers
• Operations managers and engineers
• Contract manufacturers
• Suppliers

Course Outline

Day One

• Quality Systems Regulation and Standards for medical devices and test method validation (21 CFR Part 820 and ISO13485:2016)
• Use of test methods in the product life-cycle – design, production, post-production
• Design Control and Risk Management – links to Test Method Validation
• Basic principles of Test Method Validation
  • Range
  • Resolution
  • Linearity
  • Precision, accuracy and bias
  • Repeatability and reproducibility
  • Stability
  • Robustness
  • Suitability determination
• Calibration requirements
• Qualification of test equipment

Day Two

• Basic statistical requirements for Test Method Validation
• Gage R&R for variable data
• Gage R&R for attribute data
• Test Method Validation requirements for Analytical Methods
  • Selectivity; specificity
  • Limit of quantitation
  • Limit of detection
• Method transfer
• Validation lifecycle and changes to test methods
• Conclusion

RAPS RAC Recertification Credits

Test Method Validation Training has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Winovia is a Regulatory Affairs Professionals Society (RAPS) Professional Development provider. Winovia is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. Winovia has agreed to follow RAPS’ established operational and educational criteria.

Cost

$1,500 per attendee

Early-Bird Pricing $1,400 through June 2nd
Group price for 3 or more attendees from same company – $1,400/per person
REGISTER NOW

Registration is limited to 30 attendees
Cost includes all training materials, breakfast and lunch all four days, morning and afternoon breaks
Training materials are distributed on a USB drive, so each participant must bring a laptop computer with a USB drive with them.
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Location

Hotel Information

Summit Executive Centre is located within walking distance of dozens of Chicago’s most exciting hotels. Listed below are some of the hotels within walking distance that sometimes offer special rates for Summit Executive Centre Guests. There are many other hotels within walking distance as well. Attendees are responsible for securing their own hotel accommodations. Please call the hotel and ask if they have a Summit Executive Centre room rate. You can also contact one of the many of the other hotels or AirBNBs within walking distance if the hotels listed below do not meet your needs.

Meet Your Instructor

Dr. Vinny Sastri is the president of WINOVIA^® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. He has over 25 years of experience in quality, product development and manufacturing. Areas of expertise include product design and development, design controls, process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, manufacturing, risk management, CAPA, and plastics and materials. Dr. is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. Dr. Sastri’s book Plastics in Medical Devices: Properties, Requirements and Applications was released on April 1st, 2010 by Elsevier, London.

Contact Information