Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Steven S. Kuwahara

Data Integrity has always been a major issue with FDA. If the data presented to FDA in submissions, and if the data employed by the company to release products and support the safety of those products, are unreliable, it is difficult to protect the product from unreliable or even dangerous material. 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 who are not familiar with US practices. Thus the FDA has increased its review and inspection activities in this area.

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

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.