UBM India announces 4th Annual Data Integrity, Reliability and Quality Metrics Workshop 2018

 

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.  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.

UBM India is pleased to organise the ‘4th Annual Data Integrity, Reliability and Quality Metrics Workshop 2018' on 6th - 7th March at Radisson Blu, Hyderabad and 8th - 9th March at Hotel Sahara Star, Mumbai

Key topics
• Data IntegrityInvestigations of Deviations, OOS, Market Complaints, Audit findings arriving at the Root Cause & CAPA
- 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
- Data Integrity questions as a part of an inspection
- Implementing and running a robust DI program
 • Group Exercises
- Analysis of an FDA Warning Letter
- Assessing a System for Data Integrity
Implementing and running a robust DI program
Cultural Excellence

Who will attend
• Executives
• Principal Scientist
• Managers
• Senior Managers
• General Managers Scientist
• Deputy General Manager
• Business Head
• Assistant Director
• Director
• Associate Vice-President
• Vice-President
• Manufacturing
• Analytical Development Laboratories
• CRO’s and CMO’s
• Data Integrity Officers
• QA/QC
• Global Quality
• CSV
• Validation
• Compliance
• Engineers
• Quality Risk
• Regulatory

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