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Paving the Way to Validation Excellence

October 22-24, 2018
  • San Diego, CA

Convening validation professionals of all levels for unmatched training, IVT’s 24th Annual Validation Week provides a transformative exploration through the world of validation. Build your own conference adventure and trek your way between four unique tracks — Process Validation, Quality, CSV/Data Integrity and Cleaning Validation. Navigate the critical aspects of validation with subject matter expert trailblazers and uncover a wide range of solutions to your organization’s specific challenges. With three FDA presenters and over 30 thought leaders, take this opportunity to learn about expected regulatory changes, including the impending draft guidance on non-product CSV software and the anticipated final guidance on data integrity and compliance with CGMP for industry.

Back by popular demand and rave reviews, IVT will host the 2nd Annual Women in Validation Empowerment Summit featuring a diverse panel of accomplished women in the validation and engineering field to lead an inspiring and constructive conversation where participants can share practical techniques for optimizing performance both personally and professionally.

Featured FDA Keynote Presentations:

  • Insight From the FDA Office of Regulatory Affairs — Learn from Recent Inspections to Increase Efficiencies and Decrease Violations
    Raymond Brullo, DPM
    Compliance Officer, Office of Regulatory Affairs
    U.S. Food and Drug Administration
    Linda Thai
    Consumer Safety Officer, Office of Regulatory Affairs
    U.S. Food and Drug Administration
  • FDA Center for Devices and Radiological Health (CDRH) Address — Understand How the Regulator and Industry Can Collaborate More Effectively Francisco Vicenty
    Program Manager, Case for Quality, CDRH
    U.S. Food and Drug Administration (invited)

Plus! IVT hosts the First FDA-CDRH Collaborative Community bringing medical device professionals together with FDA to brainstorm solutions to the Benefit-to-Risk balance. To submit an application to participate, visit: http://blog.cbinet.com/IVT-FDA

40+ In-depth Educational Sessions, Including:

  • Optimize Cost Reduction in Process Validation Using a Risk-Based Approach
  • From the Trenches —
    How to Develop a Transfer Plan for a Site Move and Lessons Learned from Managing Validation Processes during an Acquisition
  • Establish a Global Change Control Process
  • Practical Application of Risk Management Tools to Develop Effective Process Validation
  • Recent Changes in GMPs, Focus on EU Annex 1 and How the Validation of Cleanrooms Is Evolving
  • Managing Computer Systems Validation in an Agile World
  • The Art of Technology Transfer — Execute Cleaning Validations and Assessments for New Facilities and Equipment
  • Bulletproofing Your CSV Program —
    Where to Start and How to Build for Success
  • Establish a Site-Wide or Enterprise-Wide Data Governance Program to Ensure Your Data Integrity
  • Preparing an Effective Qualification (Validation) Master Plan
  • ...and many more!

Join us where a world of validation knowledge awaits. DOWNLOAD BROCHURE

Previous Attendee Acclaim:

I’ve learned a lot of great information which will greatly impact our processes and help us to address pressing needs.

Senior Validation Manager, Carestream Health

Great for understanding and staying current with regulatory expectations. Really helped me think about alternative approaches in several quality system areas.

Director of Validation Engineering, Edwards Lifesciences

The conference provided great refresher material and innovative ways of addressing new industry challenges.

Quality Engineer, MTF

The knowledge of the speakers provided for
thorough and in-depth discussions.

Validation Project Lead, Grand River Aseptic Manufacturing

Very informative, lots of great, usable information.

Validation Specialist, Precision Medical Products

24th Annual Validation Week

Paving the Way to Validation Excellence

Convening validation professionals of all levels for unmatched training, IVT’s 24th Annual Validation Week provides a transformative exploration through the world of validation. Build your own conference adventure and trek your way between four unique tracks — Process Validation, Quality, CSV/Data Integrity and Cleaning Validation. Navigate the critical aspects of validation with subject matter expert trailblazers and uncover a wide range of solutions to your organization’s specific challenges. With three FDA presenters and over 30 thought leaders, take this opportunity to learn about expected regulatory changes, including the impending draft guidance on non-product CSV software and the anticipated final guidance on data integrity and compliance with CGMP for industry.

Back by popular demand and rave reviews, IVT will host the 2nd Annual Women in Validation Empowerment Summit featuring a diverse panel of accomplished women in the validation and engineering field to lead an inspiring and constructive conversation where participants can share practical techniques for optimizing performance both personally and professionally.

Featured FDA Keynote Presentations:

  • Insight From the FDA Office of Regulatory Affairs — Learn from Recent Inspections to Increase Efficiencies and Decrease Violations
    Raymond Brullo, DPM
    Compliance Officer, Office of Regulatory Affairs
    U.S. Food and Drug Administration
    Linda Thai
    Consumer Safety Officer, Office of Regulatory Affairs
    U.S. Food and Drug Administration
  • FDA Center for Devices and Radiological Health (CDRH) Address — Understand How the Regulator and Industry Can Collaborate More Effectively Francisco Vicenty
    Program Manager, Case for Quality, CDRH
    U.S. Food and Drug Administration (invited)

Plus! IVT hosts the First FDA-CDRH Collaborative Community bringing medical device professionals together with FDA to brainstorm solutions to the Benefit-to-Risk balance. To submit an application to participate, visit: http://blog.cbinet.com/IVT-FDA

40+ In-depth Educational Sessions, Including:

  • Optimize Cost Reduction in Process Validation Using a Risk-Based Approach
  • From the Trenches —
    How to Develop a Transfer Plan for a Site Move and Lessons Learned from Managing Validation Processes during an Acquisition
  • Establish a Global Change Control Process
  • Practical Application of Risk Management Tools to Develop Effective Process Validation
  • Recent Changes in GMPs, Focus on EU Annex 1 and How the Validation of Cleanrooms Is Evolving
  • Managing Computer Systems Validation in an Agile World
  • The Art of Technology Transfer — Execute Cleaning Validations and Assessments for New Facilities and Equipment
  • Bulletproofing Your CSV Program —
    Where to Start and How to Build for Success
  • Establish a Site-Wide or Enterprise-Wide Data Governance Program to Ensure Your Data Integrity
  • Preparing an Effective Qualification (Validation) Master Plan
  • ...and many more!

Join us where a world of validation knowledge awaits. DOWNLOAD BROCHURE

Previous Attendee Acclaim:

I’ve learned a lot of great information which will greatly impact our processes and help us to address pressing needs.

Senior Validation Manager, Carestream Health

Great for understanding and staying current with regulatory expectations. Really helped me think about alternative approaches in several quality system areas.

Director of Validation Engineering, Edwards Lifesciences

The conference provided great refresher material and innovative ways of addressing new industry challenges.

Quality Engineer, MTF

The knowledge of the speakers provided for
thorough and in-depth discussions.

Validation Project Lead, Grand River Aseptic Manufacturing

Very informative, lots of great, usable information.

Validation Specialist, Precision Medical Products