CPhI Conferences, a division of UBM India has announced the 4th Annual ‘Data Integrity, Reliability and Quality Metrics Workshop’ scheduled on March 6 & 7, 2018 at Radisson Blu, Hyderabad and March 8 & 9, 2018 at Hotel Sahara Star, Mumbai.

Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. Company quality management systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the quality control laboratory and in operations (manufacturing and engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues.

Indicators of potential data integrity issues are an unreasonably low number of deviations, OOS incidents and EM excursions.

The pharmaceutical industries must give immediate and strategic consideration to data integrity practices for two critical reasons:1) Increased attention to data integrity shortcomings by global regulatory agencies and 2) The possibility of a less stringent regulatory environment.

To understand the pressing ramifications of the data integrity issue, we must remind ourselves that data is both the backbone of CGMP compliance and the fuel of the digital economy.

Regulatory non-compliance is always a serious area of concern for the Indian pharmaceutical sector. With 13 warning letters being issued in FY 2015 and 9 warning letters in FY 2016, Data integrity still continues to be a severe problem to be tackled.

In this context, this practical case-study and highly interactive content-driven workshop by UBM India which will enhance knowledge and upgrade skills to address the data integrity issues.

Key topics of the conference include: Data integrity, setting the scene, beyond the Lab, DI training and the behavioural elements, investigations of deviations, OOS, market complaints, audit findings arriving at the root cause & CAPA, reviewing, identifying, archiving, retrieval of the laboratory or shop floor data – A.L.C.O.A

Case studies include: Data integrity questions as a part of an inspection, implementing and running a robust DI programme.

Group exercises include: Analysis of an FDA warning letter, assessing a system for data integrity, implementing and running a robust DI programme and cultural excellence.

For further details, visit www.ubmindia.in.