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Process Validation & Continued Verification

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Develop, Implement and Maintain Risk-Based Programs Enterprise-Wide

May 20

Virtual, United States

FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Although the concept was introduced in 2011, industry still struggles with the complex challenges of our rapidly change quality and technical environments. KENX is proud to present this virtual training that help you master the 3-stage life cycle approach and the innovative processes, techniques and compliance trends to make an immediate impact in your organization.

 

Top Reasons to Attend

  1. FDA’s 3-Stage Approach – Implement a Risk- and Science-based, Life Cycle Approach
  2. Risk Management – Understand Where, When and How to Implement in Validation
  3. Statistics – Learn Statistics in Validation for Decision-making
  4. ICH Guidelines – Review ICH Q8, Q9, Q10 and Q11
  5. Process Development (Stage 1) – Implement Risk and Quality by Design (QbD)
  6. Performance Qualification – Know IQ/OQ/PQ Principles
  7. Continuous Process Verification (Stage 3) – Implement an Effective Program
  8. Acceptance Criteria – Develop Sampling Plans and Set Limits
  9. Change Control – Know the Interrelationship with Validation

 

Personnel in the Following Environments Should Attend:

  • Validation
  • Quality Assurance
  • Engineering
  • IT
  • Commissioning & Qualification
  • Quality Control
  • Manufacturing Management
  • Laboratory Management
  • Regulatory Affairs

 

This event is also appropriate to business development and sales managers that offer innovative solutions for quality validation and engineering professionals in the life science industry.

Agenda

  • 10:45 AM EST
    Webinar Host Opening Remarks
    Howard Wilensky, Executive Director, KENX
  • 11:00 AM – 12:30 PM EST
    Implement a Risk-based CSA Program Aligned with New FDA Expectations
    David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
  • 12:30 – 12:45 PM EST
    Break
  • 12:45 – 2:15 PM EST
    Continued Process Verification (CPV) – Maintain the Validation State
    Phil Jarvis, Global C&Q lead for EU, Abbvie (EU)
  • 2:15 – 2:30 PM EST
    Break
  • 2:30 – 4:00 PM EST
    Introduction to Statistics in Validation
    Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
  • 4:00 – 4:15 PM EST
    Break
  • 4:15 – 5:45 PM EST
    Hands Free Validation – Execute Validation 100% Remote and 100% Paperless
    Steve Thompson, Director Industry Solutions, ValGenesis
  • 5:45 PM EST
    Close of Virtual Training

Faculty

  • David W. Vincent, Ph.D., CEO, VTI Life Sciences

    David Vincent has over thirty-two (32) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (20) twenty years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, B.Sc., Mechanical Engineering Technology, Master and Ph.D. in public health. He has hands-on experience in many areas of regulatory affairs, quality assurance and commission/qualification, engineering including; regulatory submission preparation, design review, microbiology laboratory setup and qualification, construction qualification, project management, utility and process FAT/SAT commission plans, and equipment qualification implementation.
  • Philip Jarvis, Global C&Q Lead, Abbvie

    Mr. Jarvis is an experienced team leader with over 20 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device / pharmaceutical / and biologics industries.
  • Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care

    Raul Soto is a Senior Principal Software Engineer at Johnson & Johnson Vision Care (JJVC), focused on Computerized Systems Validation and Software Quality Engineering. Mr. Soto has over 20 years of experience in validation, process engineering, industrial automation, and software quality; and has held positions of increasing responsibilities in the medical devices, biotechnology, pharmaceutical, and consumer electronics industries. Raul has led multiple global and site projects in the United States, Europe and China. As an invited speaker he has lectured on computer systems validation, data integrity, statistics, PLC/SCADA automation, and quality/compliance issues at various conferences in the United States and Europe. Raul has an MS degree in Biotechnology with emphasis on Biomedical Engineering, and a BS degree in Mechanical Engineering. He is also an ASQ Certified Quality Engineer (CQE).
  • Steve Thompson, Director Industry Solutions, ValGenesis

    Mr. Thompson has a Bachelor of Science in Computer Information Systems and has worked in Life Sciences for over 20 years. Steve was certified as a PDA computer systems auditor, has audited hundreds of companies globally, is a published author, and a frequent speaker. Currently he is Director Industry Solutions at ValGenesis, Inc.

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Venue

Details

Date:
May 20
Event Category:

Venue

Remote
Virtual, United States

Pricing & Registration

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