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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)
Data Integrity:Regulatory expectation and findings on GMP Inspection
Hiroyuki Kawakita
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Specialist (for Inspection)
The Latest Global Regulatory Trends on Data Integrity and Issues to be Addressed by the Pharmaceutical Industries
Satoshi Morino
Eisai Co., Ltd., Japan
Kashima Quality Assurance, Japan Regional Quality, Global Quality HQs
Data Integrity Remediation Activities for Inspection Readiness and Outcome of FDA Inspection
Atsuto Kobe
Chugai Pharmaceutical Co., Ltd., Japan
Pharmaceutical Technology Quality Dept