The Glassed pacemaker for process validating manufacturing a a Divine

Advanced Process Validation Training
4 Day Interactive Training Program
May 16-19, 2017
Summit Executive Centre
Downtown Chicago, IL USA

Pre-approved by RAPS for 12 credits towards RAC recertification. See details below.

There are no prerequisites for this course.

Registration is closed for this event.

Course Description

Process Validation has been the number one citation in Production and Process Controls for both FDA 483s and Warning Letters for the last 10 years!

Is your Process Validation System effective? Will it pass an audit or inspection?

This training is your chance to implement and maintain a robust and effective process validation system, whether you’re new to process validation or seeking to improve your knowledge and expertise.

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. The training emphasizes the connectivity between design controls, risk management and statistical techniques. Advanced Process Validation for Medical Devices will also provide participants the fundamental knowledge and tools to establish and implement effective process validation lifecycle systems. In addition, hands-on, interactive exercises will highlight and reinforce the principles learned.

Learning 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
  • 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

Who Will Benefit

  • Operations and Manufacturing Managers and Engineers
  • Process Engineers
  • Quality Assurance & Quality Control
  • Consultants
  • Process Engineers
  • Project Managers
  • Product Design and Development Managers and Engineers
  • Contract Manufacturers
  • Suppliers to the Medical Device Industry

RAPS RAC Recertification Credits

Advanced Process Validation — Practical Solutions & Strategies for the Medical Device Industry 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.

Course Outline

Day One

  • Quality Systems Regulation and Standards for medical devices and process validation (21 CFR Part 820 and ISO13485:2016)
  • Design Control and Risk Management – links to Process Validation
  • Process validation prerequisites including validated test methods
  • Verification versus Validation
  • Master Validation Plans
  • Use of equivalency of equipment and processes in process validation
  • Software Validation overview
  • Installation Qualification (IQ); protocols and reports

Day Two

  • Basic statistics and quality metrics calculations
  • Sample size determination based on risk
  • Design of experiments – screening, optimization and response surface analysis
  • Process development / Engineering studies – identification of critical process parameters and raw material characteristics

Day Three

  • Operational Qualification (OQ); protocols and reports
  • Performance Qualification (PQ); protocols and reports
  • Validating Manual Processes
  • Methods for:
    • Cleaning Validation
    • Facilities Qualification and Validation
    • Utilities Qualification and Validation
    • Sterilization Validation
  • Outputs from Process Validation

Day Four

  • Developing a Process Failure Mode and Effects Analysis (pFMEA)
  • Process monitoring and control; control charts
  • Analysis of process monitoring data
  • Revalidation and process changes — link to change control
  • Analysis of historical data
  • Documentation of process validation
  • Conclusion and wrap-up


Summit Executive Centre
205 N Michigan Av
Chicago, IL 60601

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

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

For information on registration, pricing, hotels or other logistical concerns, please contact Tim Schapker.
For information on course content, please contact Dr Vinny Sastri.