Best Practices for Out-of-Specification (OOS) Investigations
: 29 Jun 2021
Fees: £70 PHARMIG MEMBERS Join Now, £100 (Non Member)
The Zoom session will last for 60 minutes and include a Q&A section
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?