Webinar content

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:

Alignment of Data Integrity checks in an audit agenda
Data Integrity key points & verification strategy in manufacturing & maintenance
Data Integrity key points & verification strategy in quality control
Data Integrity governance
Tips and tricks. Running away from a well-prepared story

Examples of most common observations will be shown during the webinar and it will be enabled a space for questions and answers.

Target group

Technical staff from API, and Pharmaceutical industry.

Speaker’s background

Sergi Arcas

TDV Software Area Manager

Chemical Engineer with 19 years of professional experience in the Pharmaceutical and API industry, as well as in the GLP/GCP areas, as consultant in TDV. Responsible of conducting hundreds of computerized system validation projects of all kinds and also tenths of Data Integrity specific audits in companies.
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.