4th Annual Data Integrity, Reliability and Quality Metrics Workshop to be held in Hyderabad and Mumbai

The workshop by UBM India will enhance knowledge and upgrade skills to address the DI issues

CPhI Conferences, a division of UBM India, will organise 4th Annual ‘Data Integrity, Reliability and Quality Metrics Workshop’ scheduled on March 6 -7, 2018 in Hyderabad and from March 8-9, 2018, in 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 scrutinised 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 DI issues are an unreasonably low number of deviations, OOS incidents and EM excursions.

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

The workshop by UBM India will enhance knowledge and upgrade skills to address the DI issues.

Key topics of the conference include

• Data integrity

1. Setting the scene
2. Beyond the lab
3. 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

1. Data Integrity questions as a part of an inspection
2. Implementing and running a robust DI programme

• Group Exercises

1. Analysis of an FDA Warning Letter
2. Assessing a System for Data Integrity
3. Implementing and running a robust DI programme
4. Cultural Excellence