Best practices for out-of-specification (OOS) investigations

£100.00 (Member price £70.00 - Join Now)

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Fees: £70 PHARMIG MEMBERS Join Now,  £100 (Non Member)

The Zoom session will last for 60 minutes and include a Q&A section

Webinar Outline

Best practices for out-of-specification (OOS) investigations Led by Dr Tim Sandle

Tuesday 29th June @3pm BST

This presentation looks at the best practices for laboratory out of specification (OOS) investigations. The OOS approach discussed will relate to both microbiological and chemical test samples.

  • What makes for a good and a bad OOS investigation?
  • What needs to be done for the different OOS phases?
  • How can laboratory errors be assessed?
  • How and OOS’s be trended?
  • What is needed for robust hypothesis testing?
  • What needs to be considered for a production or process investigation?
  • How should the OOS be documented?

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Additional information