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Faculty: John E. Lincoln

  • Date: 9/29/2020 11:00 AM - 9/29/2020 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event


Verification and validation requirements for production and test equipment hardware and software / firmware have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution. In this webinar we will address both the V&V system as well as consider practical implementation by means of examples.

Areas Covered in the Session :

  • Verification or Validation – Recent regulatory expectations
  • The Master Validation Plan / structure
  • Process / Equipment / Facility Validation – FDA’s new guidance
  • When and How to use DQ, IQ, OQ, PQ, or their equivalents
  • How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
  • The 11 key documents for software validation
  • Incorporating 21 CFR Part 11 requirements
  • Suggested “test case” formats
  • Production / test equipment / software examples

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Everyone tasked with product, process, software validation responsibilities