Process Validation Training

Practical Solutions & Strategies for the Medical Device Industry
Process Validation Training


Registration ends September 16th!

2 1/2 Day Interactive Training Program
September 21 – 23, 2016
Summit Executive Centre
Downtown Chicago, IL USA


Registration is limited to 40 attendees
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Course Description

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. This two-and-a-half day 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.  A hands-on, interactive process validation exercise will be used to highlight the principles learned.

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

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 1

  • Quality Systems Regulation and Standards for medical devices and process validation
  • Design Control and Risk Management – links to Process Validation
  • Process validation prerequisites including validated test methods
  • Basic statistics and quality metrics calculations
  • Verification versus Validation
  • Validation Master Plans
  • Process development / Engineering studies and Design Controls
  • Introduction to Design of Experiments (DOE)


  • Calculating quality metrics
  • Determining sample size based on risk
  • Creating master validation plans
  • Analyzing a design of experiments using a case study and determining the critical process parameters
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
  • Be able to calculate basic quality metrics and determine sample sizes
  • Learn to identify which processes to verify and which process to validate
  • Develop a Master Validation Plan
  • Learn to to use statistical methods like design of experiments (DOE) to determine critical process and raw material parameters
Day 2

  • Installation qualification (IQ)
  • Automated Processes and Software validation overview
  • Operational qualification (OQ)
  • Performance qualification (PQ)
  • Validating manual processes
  • Overview of methods for cleaning, facilities, utilities, and sterilization validation


  • Filling out protocols and reports for an IQ, OQ, PQ based on a case study
  • Completing a validation summary report
  • Hands-on team exercise in planning, conducting and analyzing an IQ, OQ and PQ
Learning Objectives

  • Learn the elements of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
  • Learn how to incorporate software validation into an IQ
  • Develop protocols and reports for an IQ, OQ and PQ
  • Understand how to address deviations during protocol execution
Day 3 (half day)

  • Process Failure Mode and Effects Analysis (PFMEA)
  • Process Monitoring and Control
  • The validation life-cycle and revalidation
  • Documentation for process validation
  • Conclusion and wrap-up


  • Developing a PFMEA
  • Populating a DMR
  • Evaluating data from statistical process controls scenarios
  • Calculating process and product capability
  • Revalidation
Learning Objectives

  • Understand the basics of a 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
  • Know the documentation requirements for process validation activities


$1,750 per attendee


Registration ends September 16th!

Registration is limited to 40 attendees
Group price for 3 or more attendees from same company – $1,450/per person
Cost includes all training materials, breakfast all three days, lunch days 1 & 2, 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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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 Premiere Hotel Partners within walking distance of the training location which 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 for the Summit Executive Centre room rate. You can also want to contact one of the many of the other hotels within walking distance if the hotels listed below do not meet your needs.
The Fairmont
200 North Columbus Drive (0.2 Miles)
The Fairmont website

Swissotel (0.4 Miles)
323 East Upper Wacker Drive
Swissotel website

Club Quarters (0.3 Miles)
75 East Upper Wacker Drive
Club Quarters website

Downtown Marriott (0.5 Miles)
540 North Michigan Avenue
Downtown Marriott website

theWit (0.2 miles)
201 North State Street
theWit website

Virgin Hotel (0.1 Miles)
203 North Wabash
Virgin Hotel website

Hyatt Regency (0.2 Miles)
151 East Upper Wacker
Hyatt Regency website

Hard Rock Hotel (0.1 Miles)
230 North Michigan Ave
Hard Rock Hotel website

Radisson Blu (0.3 Miles)
221 North Columbus Drive
Radisson Blu website

Meet Your Instructor

Vinny Sastri, PhD

Vinny Sastri, PhD

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.

(518) 253-7751


For information on course content, please contact Dr Vinny Sastri.

(773) 348-8577


Exciting Downtown Chicago

Summit Executive Centre is located in the heart of Downtown Chicago on the famous Magnificent Mile. Millennium Park, Navy Pier, and the world’s best museums, world-class theater, beautiful parks, celebrated restaurants, architecture that awes, and shopping for days are all just blocks from the training location.

Chicago is a city built on the shores of greatness. To start your adventures check out the Chicago Convention and Tourism Bureau’s website.


Dr Sastri is truly an expert in his field. I personally appreciate the caliber of his treatment of this course.
Dr Sastri did a great job presenting, keeping us actively involved and answering our questions. I would look forward to attending more of his seminars.
Really excellent. The breakout sessions were productive breaks and really solidified information by applying to real case scenarios.
Dr Sastri did a great job presenting, keeping us actively involved and answering our questions. I would look forward to attending more of his seminars.
Very useful and professional. A lot of information to work on. I learned a lot!