Data Integrity is a key element to be verified during the audits to pharmaceutical and API companies and still a big source of observations in both customer and health agencies ones. Therefore, it is necessary to conduct data integrity checks during them, but it is not possible that this activity monopolizes all the audit time. Data Integrity is not all the GMPs.
Consequently, it should be balanced the time used for data integrity checks and all the other checks in the audit, obtaining the most information for the inverted time and preventing that this topic distorts a well-planned agenda.
In this Webinar we will share our knowledge and experience from having carried out hundreds of audits of APIs and finished products, in which data integrity evaluation has been a key element. The Webinar will depict the key considerations to do an effective data integrity review, including:
Examples of most common observations will be shown during the webinar and it will be enabled a space for questions and answers.
Technical staff from API, and Pharmaceutical industry.
He is qualified as AFA lead auditor since 2008 and he has conducted around 100 worldwide audits to suppliers and manufacturers of Pharmaceutical and Chemical Industries.