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[V8-S2] The Latest Regulatory Trend and Counter Measures for Data Integrity
Session Chair(s)
Shuji Sumida, MSC, RPH
Director, Project Quality and Risk Management, Japan
The integrity of required scientific data and process records in ensuring the quality, efficacy, and safety of drugs has come under the spotlight. One major reason for this trend is instances of the alteration and falsification of data and records at a number of drug manufacturing sites. Steps such as access controls and review of audit trails are thus needed to stop intentional fraud, and the FDA has issued some warning letters in the last few years because of insufficient measures to ensure data integrity. Such factors have led to data integrity coming under closer scrutiny, with guidances issued for all GxP areas, not only GMP. In this session, we will discuss the main issues and what we can do to resolve them, taking a look at the latest regulations and recent inspection findings.
Speaker(s)
Hiroyuki Kawakita
Specialist (for Inspection), Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Data Integrity:Regulatory expectation and findings on GMP Inspection
Satoshi Morino
Kashima Quality Assurance, Japan Regional Quality, Global Quality HQs, Eisai Co., Ltd., Japan
The Latest Global Regulatory Trends on Data Integrity and Issues to be Addressed by the Pharmaceutical Industries
Atsuto Kobe
Pharmaceutical Technology Quality Dept, Chugai Pharmaceutical Co., Ltd., Japan
Data Integrity Remediation Activities for Inspection Readiness and Outcome of FDA Inspection
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