Process Validation Training

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

Process Validation Training

Process Validation Training – Practical Solutions and Strategies for the Medical Device Industry
3-Day Interactive Training Program
July 23-25, 2019
Summit Executive Centre
Downtown Chicago, IL USA

This Process Validation Training course has no prerequisites.

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Process Validation Training – 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? Above all, will it pass an audit or inspection?

This process validation 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, this training can help.

With a focus on in-depth process validation methods and statistical rigor, this 3-day Process Validation Training for Medical Devices will explain the intent and importance of process validation with respect to the ever-evolving regulations and standards. The training emphasizes the connectivity between design controls, risk management, supplier controls and statistical techniques. Process Validation Training 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, practical, interactive exercises and case studies will highlight and reinforce the principles learned. Each participant will receive a complete suite of procedures, forms and templates.

Process Validation Training – Learning Objectives

  • Understand the intent and purpose of regulations and standards as they apply to process validation and production controls
  • Know how design controls and risk management feed into process validation
  • Learn the difference between process validation and process verification, and identify which processes to verify or 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), Operational Qualification (OQ) and Performance Qualification (PQ) using protocols and reports
  • Identify key outputs from process validation including process failure mode and effects analysis (pFMEA) and supplier controls
  • 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 from Process Validation Training

  • 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

Process Validation Training – Course Outline

Each day will include interactive exercises and case studies. Each participant will receive a complete suite of procedures, forms and templates.

Day One

  • Quality Systems Regulation and Standards for medical devices and process validation (21 CFR Part 820, ISO13485:2016, MDSAP, EU MDR and EU IVDR)
  • Design Control and Risk Management – inputs to Process Validation
  • Verification versus Validation
  • Validation Master Plans; validation planning
  • Basic statistics and quality metrics calculations
  • Sample size determination based on risk
  • Design of experiments – screening, optimization and response surface analysis

Day Two

  • Installation Qualification (IQ); protocols and reports
  • Software Validation overview
  • Process development / Engineering studies – identification of critical process parameters and raw material characteristics
  • Operational Qualification (OQ); protocols and reports
  • Performance Qualification (PQ); protocols and reports
  • Validating Manual Processes
  • Overview of Cleaning Validation, Facilities Qualification and Validation, Utilities Qualification and Validation, Sterilization Validation

Day Three

  • Outputs from Process Validation
    • Process Failure Mode and Effects Analysis (pFMEA) overview
    • Process monitoring and control; control charts; statistical process control (SPC) and statistical quality control (SQC)
    • Supplier controls
  • Revalidation and process changes – link to change control
    • The validation life-cycle
    • Analysis of process monitoring data
    • Use of equivalency of equipment and processes in process validation
  • Documentation of process validation
  • Conclusion and wrap-up

Cost

3-day Process Validation Training
$1,900 per attendee
$1,700 per attendee with early registration before May 31st
$1,650 per attendee with a group registration of 3 or more from the same company
Training Terms and Conditions

EVENT REGISTRATION
For registration we partner with Eventbrite

Location

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 best hotels. Listed below are some of the hotels within walking distance from Summit Executive Centre Guests. There are many other options within walking distance as well. Attendees are responsible for securing their own accommodations. You can also contact one of the many other hotels or AirBNBs within walking distance if the hotels listed below do not meet your needs.
THE FAIRMONT
200 North Columbus Drive
312-565-6661
0.2 Miles to SUMMIT EXECUTIVE CENTRE
The Fairmont website

SWISSOTEL
323 East Upper Wacker Drive
312-565-0565
0.4 Miles to SUMMIT EXECUTIVE CENTRE
Swissotel website

CLUB QUARTERS
75 East Upper Wacker Drive
312-601-3514
0.3 Miles to SUMMIT EXECUTIVE CENTRE
Club Quarters website

CHICAGO MARRIOTT DOWNTOWN MAGNIFICENT MILE
540 North Michigan Avenue
312-836-0100
0.5 Miles to SUMMIT EXECUTIVE CENTRE
Downtown Marriott website

THEWIT
201 North State Street
312-239-9528
0.2 Miles to SUMMIT EXECUTIVE CENTRE
theWit website

VIRGIN HOTELS
203 North Wabash
855-946-6600
0.1 Miles to SUMMIT EXECUTIVE CENTRE
Virgin Hotel website

HYATT REGENCY
151 East Upper Wacker
312-239-4547
0.2 Miles to SUMMIT EXECUTIVE CENTRE
Hyatt Regency website

ST. JANE
230 North Michigan Ave
312-334-6489
0.1 Miles to SUMMIT EXECUTIVE CENTRE
St. Jane website

RADISSON BLU
221 North Columbus Drive
312-477-0236
0.3 Miles to SUMMIT EXECUTIVE CENTRE
Radisson Blu website

Meet Your Instructor

Vinny Sastri, PhD

Vinny Sastri, PhD

Dr Vinny Sastri

Dr. Vinny Sastri is the President of WINOVIA® LLC a company that provides customized solutions, strategies and training in the implementation of effective quality management systems.  Dr. Sastri is a leading industry expert in FDA and ISO quality management systems, product development, design controls, risk management, manufacturing and process validation, six sigma and design for six sigma, CA/PA and materials. He is a certified Six Sigma black-belt. He has a strong track record in leading, managing, establishing and implementing quality initiatives into client organizations around the world, resulting in efficient and effective quality management systems and operational excellence. Dr. Sastri is the author of Plastics in Medical Devices: Properties, Requirements and Applications published by Elsevier, London. Learn more about Dr Vinny Sastri.

Contact Information

For information on registration, pricing, hotels or other logistical concerns, please contact Tim Schapker.

(518) 253-7751

training*winovia.com

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

(773) 348-8577

training*winovia.com

Exciting Downtown Chicago

Chicago
Summit Executive Centre is located in the heart of Downtown Chicago on the famous Magnificent Mile. Millennium Park, Navy Pier, museums, theater, parks, restaurants, world-famous architecture, and shopping are all just blocks from the training location.

To plan your adventures check out the Chicago Convention and Tourism Bureau’s website.

Testimonials

“Walking through the real-world examples gave a better insight to Process Validation.”

“Dr Sastri did a great job highlighting what the FDA has required in respect to the compliance of good manufacturing, good design practices and management.”

“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!”