A Risk-Based Approach to Validation for Life Sciences Companies

1.0 RAC Credits On-demand On-demand Member: $0.00 Nonmember: $20.00

A Risk-Based Approach to Validation for Life Sciences Companies

This is an on-demand recording from February 2021


Join ETQ’s Alex Alain to hear about the trends surrounding how companies need to validate their QMS systems to ensure the highest quality of their products. Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.

During the discussion, Alex will reference ETQ’s Expedited Validation Product and Services as examples of how companies can most effectively leverage today’s approach to validation while maintaining compliance with industry regulations.

Join Alex to hear about:

  • Trends and pains impacting validation for Life Sciences firms
  • Risk-based approach to Validation
  • Validation Tools that organizations should be using today to ensure compliance
  • ETQ’s QMS and Validation offerings

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objectives

Upon the conclusion of the program, you will be able to:

  • To understand risk based validation approach and be able to apply to your organization’s processes.
  • Use risk based validation to meet compliance requirements
  • How to reduce validation complexity

Who Should Attend

  • System Administrators
  • IT
  • CEO/President
  • Vice President
  • Executive Director
  • Director
  • Manager
  • Project Manager
  • Specialist
  • Associate
  • Coordinator
  • Regulatory Counsel
  • Regulatory Information Specialist

Speaker


Alexandre Alain, Quality Validation Manager, ETQ

Alexandre Alain has experience in different regulated industries, but mostly in the Life science industry where he worked many years for Johnson and Johnson and with ETQ for the past 10 years. He touches multiple processes within Quality and Manufacturing, leads many QMS implementations, and guides customer through their Quality Management and Validation Journeys. Most recently, he has been focused on supporting ETQ customers during their validation journeys and optimizing ETQ’s validation offerings.

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