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FDA Issues and its FDA Data Integrity - 2017

Start Date:
Friday, 1 September, 2017
End Date:
Friday, 1 September, 2017 11:30am
Health & Nutrition

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 dataGuidance Documents related to Data IntegrityRequirements for Computerized Instrument OutputsDefinition of Data Integrity TermsImportance of Audit TrailsExamples of Violations 483s taken from Warning Letters Who Will Benefit:Quality Control and Quality Assurance WorkersRegulatory Affairs PersonnelProduct Development WorkersPersonnel Planning Clinical StudiesManufacturing Supervisors 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. Event Cost & Details:One Dial-in One Attendee Price: US$150.00 Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Netzealous LLC DBA - Compliance4All

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Netzealous LLC DBA - Compliance4All

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