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Cleaning Validation & Critical Cleaning Processes

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Develop, Implement and Maintain a Risk-based Program

April 15

Virtual, United States

An effective Cleaning Validation Program is a critical focus of a regulatory investigation. Having a first-rate program has never been more critical during a time where COVID-19 is changing the way we operate and interact. FDA Warning letters for violations remain high across the globe as industry continues to struggle with compliance and overcome its complicated challenges. This seminar illustrates how to develop, implement and continuously monitor a risk-based program that exceeds regulatory expectations and uses a best-in-class approach to build a successful, safe and compliant program.

 

Top 20 Reasons to Attend:

  1. Learn FDA Requirements, Critical Elements and Documentation Practices
  2. Implement a Risk-Based Approach Enterprise-Wide
  3. Learn How to Adequately Assess Your Soils and Cleaning Agents
  4. Learn How to Group Equipment and Select a Worst-Case Soil
  5. Understand the Training and Qualification Requirements for Cleaning Validation Executors
  6. Examine an Example of a Good Cleaning Validation Protocol and Report
  7. Manage Project Timelines, Communicate Necessities and Set Expectations
  8. Know the Importance of Change Control Throughout the Cleaning Process
  9. Understand Risk-based Cleaning Validation
  10. Learn Where, When and How to Conduct Risk Assessments
  11. Develop a Life Cycle Approach from Process Design to Verification
  12. Learn How to Detect Residuals and Contaminants
  13. Define Risk-Based Critical Cleaning Process Parameters and Critical Quality Attributes
  14. Understand the Importance of Coupon Studies
  15. Master the Visual Inspection
  16. Set Acceptance Criteria and Health-based Limits
  17. Determine the Level and Frequency of Testing Needed for Routine Monitoring
  18. Understand Use of Laboratory Scale Models to Develop Robust Cleaning Recipes
  19. Receive Example Documents – Templates, Checklists, Worksheets and a Validation Master Plan
  20. Learn How to Handle Failure Investigations

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • R&D
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory
  • Microbiologist, Scientist and Chemists

Agenda

  • 10:45 AM EST
    Webinar Host Opening Remarks
    Howard Wilensky, Executive Director, KENX
  • 11:00 AM – 12:30 PM EST
    Building a Cleaning Validation Program from the Ground Up
    Dawn Tavalsky, Senior Director Global Quality, Sanofi Pasteur
  • 12:30 – 12:45 PM EST
    Break
  • 12:45 – 2:15 PM EST
    Risk-Based Critical Cleaning Process Parameters and Critical Quality Attributes (CPP and CQA) – A Case Study
    Phil Jarvis, Global C&Q lead for EU, Abbvie
  • 2:15 – 2:30 PM EST
    Break
  • 2:30 – 4:00 PM EST
    Cleaning Validation Documents, SOPs and Strategy
    Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
  • 4:00 – 4:15 PM EST
    Break
  • 4:15 – 5:45 PM EST
    Troubleshooting Tools for the CIP Practitioner
    Jeff Gaerke P.E., Principal Consultant, CAI
  • 5:45 PM EST
    Close of Virtual Training

Faculty

  • Dawn Tavalsky, Senior Director of Global Quality, Sanofi

    Ms. Tavalsky is a Senior Director of Global Quality with Sanofi Pasteur, the vaccine division of Sanofi. She has over 30 years of experience in the pharmaceutical industry including small molecule, device, biologics and vaccines. She is a Sterility Assurance and Validation subject matter expert.
  • Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk

    Fred Ohsiek is the Sr Cleaning Validation Specialist and Cleaning Validation Work Package Owner for Novo Nordisk in Clayton, NC. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
  • Jeff Gaerke P.E., Principal Consultant, CAI

    With more than 30 years’ experience in biotech manufacturing, Jeff has worked as a process engineer in API manufacturing as well as formulation and filling. Serving as an engineering subject matter expert in with a focus on cleaning and sterilization, Jeff has supported manufacturing sites worldwide in the design, start-up, optimization, and troubleshooting of cleaning and sterilization processes.
  • 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.

Sponsors

  • Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there.
    Website: https://commissioningagents.com

Venue

Details

Date:
April 15
Event Category:

Venue

Remote
Virtual, United States

Pricing & Registration

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