COURSE DESCRIPTION

OVERVIEW

In multiple recent FDA warning letters, laboratory data integrity was cited as the main reason for concern.  One letter states that the identified data integrity issues “demonstrate a general lack of reliability and accuracy of data generated by the laboratory – a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm.”

This is of critical importance because without complete, accurate data, the laboratory – and therefore the firm – cannot demonstrate the product has the appropriate identity, strength, quality, and purity as stated in specification. If the integrity of your data is in question, so is the quality and safety of your product.

In order to assure your firm’s data integrity, staff must be kept up-to-date on the handling of laboratory data/results – especially failing or out of specification (OOS) data. And, since the FDA issued the OOS guidance in 2006, both the FDA and the MHRA have communicated additional expectations for OOS handling, including updates to the OOS investigation process and expectations for quality agreements to address OOS communication and management.

LEARNING OBJECTIVES

Attend this webinar to learn – or refresh your knowledge of:

1. The basic tenets that drive laboratory data integrity expectations
2. The current expectations for handling OOS investigations – including the process, roles/responsibilities, and expected outcomes
3. The differences between the US and new EU expectations for OOS handling
4. Expectations for data integrity and OOS management in CMO relationships
5. Examples of recent laboratory data handling issues identified by FDA in warning letters and 483’s
6. How to prepare your analysts/personnel to operate under these expectations
7. How to assess your process for gaps – before the auditors do