The No. 1 Trade Show Site in the U.S.

Menu
×
EVENT DATE
Sep 2017
M T W T F S S
010203
EXPO DATE
Sep 2017
M T W T F S S
010203

Venue


Online Event
Location map
Tel:
Type: Online Event

HOTEL DEALS

Booking.com

TRAVEL DEALS

Expedia.com

Partners

exhibitus success by design Remington Hotels

FDA Issues and its FDA Data Integrity - 2017

B2B

EVENT DESCRIPTION

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.

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

If the FDA Issues and its FDA Data Integrity - 2017 is important to your business, act now and make the appropriate connections. See the contact information below.

EVENT CONTACTS

Sign Up for FULL Membership and Log In to access Event Contact Information.

EVENT DETAILS

Primary Industry:
Manufacturing - General
Other Industries:
Manufacturing, Manufacturing - General
Audience:
Quality Control and Quality Assurance Workers
Regulatory Affairs Personnel
Product Development Workers
Personnel Planning Clinical Studies
Manufacturing Supervisors
Notes:
Show Owner:
Compliance4All DBA NetZealous
Sponsorship:

Exhibitor Information +

Booth Details:

Booth Size
Booth Cost
No Exhibiting
Amenities
Electricity:
n/a
Water:
n/a
Generator:
n/a
Marketing Vehicles Allowed:
n/a
Services
n/a
Show Owner
Compliance4All DBA NetZealous

floor plan

MORE events +

BUSINESS+
HEALTH CARE+
MANUFACTURING+
TECHNOLOGY+

Display Makers

Promo Makers

2017: 2,575 Trade Shows
2018: 575 Trade Shows
© copyright since 2008 All Rights Reserved eventsinamerica.com
117
page views