FDA Issues and its FDA Data Integrity - 2017

Overview:

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

Event Cost & Details:

One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile:

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.