FDA Issues and its FDA Data Integrity - 2017

7 years ago Posted By : User Ref No: WURUR13383 0
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  • TypeWebinar
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  • Location Fremont, California, United States
  • Price
  • Date 01-09-2017
FDA Issues and its FDA Data Integrity - 2017, Fremont, California, United States
Webinar Title
FDA Issues and its FDA Data Integrity - 2017
Event Type
Webinar
Webinar Date
01-09-2017
Location
Fremont, California, United States
Organization Name / Organize By
Netzealous LLC DBA - Compliance4All
Organizing/Related Departments
Healthcare Training
Organization Type
Event Management Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Information Technology

Accounting/Financial/Banking/Insurance

Location
Fremont, California, United States

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

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.

Others Details

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Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: US$150.00
Registration Ways
Email
Phone
Website
Address/Venue
  Online  Pin/Zip Code : 94539
Landmark
CA
Official Email ID
Contact
Event Manager

Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]

[email protected]

   Fax No: 302-288-6884