FDA Issues and its FDA Data Integrity - 2017

Many of the data integrity issues that plagued the US drug and biologics industry were eliminated by detailed regulations and stricter enforcement, but many of the problems have resurfaced in recent years among the multitude of foreign manufacturers whoare not familiar with US practices.

Areas Covered in the Session:

Important Regulations related to Data Integrity, including laws related to the effects of bad data
Guidance Documents related to Data Integrity
Requirements for Computerized Instrument Outputs
Definition of Data Integrity Terms
Importance of Audit Trails
Examples of Violations 483s taken from Warning Letters

Who Will Benefit:

Quality Control and Quality Assurance Workers
Regulatory Affairs Personnel
Product Development Workers
Personnel Planning Clinical Studies
Manufacturing Supervisors

Speaker and Presenter Information

Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.