Microbiology Method Validation and Verification - live online tutor-led training course

• Why validate and verify?
• When is validation or verification needed?
• How the new Standards relate to ISO 17025 requirements for validation and verification
• Introduction to ISO 16140 series of standards
• Introduction to independent method validation systems for alternative methods
• How to interpret ISO 16140 scopes of validation
• Practical guidance on the new requirements for in-house method verification in ISO 16140-3

Learning Outcomes

At the end of this course delegates will be able to:

• Understand the Importance of Method Validation and Verification
  • Participants will gain a clear understanding of why method validation and verification are critical in microbiological testing, especially under regulatory frameworks like EC 2073/2005, ISO 17025 and CLAS Standard.
• Identify When Validation and Verification Are Required
  • Participants will learn to determine the appropriate situations for performing validation and/or verification of microbiological methods.
• Interpret and Apply ISO 16140 Standards
  • Participants will be introduced to the ISO 16140 series of standards and the situations when/to whom each Standard applies.  Participants will be given guidance on how ISO16140 classifies food/non-food items to understand ISO 16140-2/6 scopes of validation, and ensure the methods they select/protocols they use are validated for the needs of the laboratory.
• Implement In-House Method Verification Using ISO 16140-3
  • Participants will receive practical guidance on how to conduct in-house method verification according to the new requirements of ISO 16140-3, to demonstrate methods achieve accurate and reliable results.
• Align Validation and Verification with ISO 17025 and other Laboratory Quality Standards such as CLAS Standard
  • Participants will understand how the new ISO 16140 standards for method validation and verification relate to ISO 17025 and the CLAS Standard requirements, and how to integrate these practices to meet accreditation standards.