Despite the guidance that is in place, many regulatory cite poor out-of-specification (OOS) Investigations and these features high up on lists of inspectorate findings. Notably these are renewed calls by agencies for the OOS investigation to be thorough, timely, unbiased, well documented and scientifically sound. Hence key challenges for many companies are with having a clear understanding of regulatory expectations on how to handle Oos Investigations. To help, this presentation takes a look at how OOS are conducted and presents different ways through which OOS investigations can be improved.

A new webinar from Tim Sandle

According to many GMP regulators, based on comments made at conference, the issue of effective OOS investigations continues to be a significant challenge for both many laboratories required to conduct investigations and for inspectors and auditors tasked with reviewing investigations. One frustration is with poor scientific thinking, a hypothesis not being set and without conclusions being backed by sound and suitable data. This webinar attempts to address these concerns.

Objectives of the Presentation

• Why there is a need for good OOS investigation
• What OOS investigations covers
• How to write a good OOS
• Detailing what to investigate and how
• How to carry out root cause analysis
• How to develop a testing hypothesis
• How to conclude an OOS effectively

Date: Thursday, 07 March 2019 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 60 Minutes