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Contact : Mr. D. L. Pandya
Classic Computer Services
B-4, Mandir Appt., Opp. P & T Colony, Jodhpur Char Rasta, Satellite Road, Ahmedabad-380 015. India.
Phone : +91 79 26740611 Telefax : +91 79 26754867
M : +91 9825457563
E-mail : mpds00@vsnl.com / dlpandya@gmail.com

Advanced Process Validation Training

Practical Solutions and Strategies for the Medical Device Industry

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

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

CLICK HERE FOR MORE INFORMATION & REGISTER

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

There are no prerequisites for this course.

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.

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.

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

  • 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

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

Cost

$2,100 per attendee

Early-Bird Pricing $1,850 through March 31st

Group price for 3 or more attendees from same company – $1,850/per person

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 an accessible USB drive.

CLICK HERE FOR MORE INFORMATION & REGISTER

Winovia LLC
2435 N Sheffield Av, A8
Chicago, IL 60614-2277
(773) 348-8577

Dr Vinny Sastri, PhD
President, Winovia LLC