A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, ...

Dublin, Sept. 18, 2024 (GLOBE NEWSWIRE) -- The "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations" webinar has been added to ...

The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Regulatory Agency (MHRA) both publish Out of Specification Investigation Guidance documents for the pharmaceutical ...

Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "OOS and OOT Investigations Course - Best Practices, Key Components and FDA Requirements" training has been added to ResearchAndMarkets.com's offering.

This course is designed to be an exploration of best practice for OOS investigations in a GMP environment. The course is aimed at the investigation of all out of expectation (OOE) results, including ...

The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including the responsibilities of ...

Implementing an electronic system to track out-of-specification results could help ensure compliance with current good manufacturing practices, but the system must be 21 CFR Part 11 compliant and easy ...

Dublin, June 19, 2025 (GLOBE NEWSWIRE) -- The "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations" webinar has been added to ...