Live Webinar on
Auditing Analytical Laboratories for FDA Compliance
Course "Auditing Analytical Laboratories for FDA Compliance"
has been pre-approved by RAPS as eligible for up to 1.5 credits
towards a participant's RAC recertification upon full completion.
Date & Time:
Tuesday, June 5, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Steven S Kuwahara
Steven S Kuwahara
Founder & Principal, GXP
Price : $245.00 (for one participant)
Steven S. Kuwahara, Ph.D. is the
founder and Principal of GXP
Auditing analytical laboratories can be complex because of the
BioTechnology LLC, a consulting firm
preparation that is often required. All of the GMP rules do not apply
that works in the areas covered by
to the laboratory; while there may be additional requirements
the GLP and GMP of drugs, biologics,
depending upon the type of testing that is being conducted.
and nutraceuticals. Steve has over
30 years of experience in
supervising quality control
In many cases, the laboratory itself may not understand what
laboratories, including an animal
regulations apply to the work that is being conducted. This
testing facility, and in performing
presentation will discuss what advance preparation is needed on the
GLP and GMP audits of internal and
part of the auditor, and discuss what the auditor should look for
external testing laboratories . Steve
during the audit. Since documentation is often an issue, a discussion
has participated in the development
of documentation problems will be presented.
of drugs and biologicals through all
phases of clinical research and final
product production. ...more
Areas Covered in the Session:
GMP regulations that apply to analytical laboratories.
Suggest a Topic
Advance preparation for the audit
Your Necessity is our Priority
Auditing styles and structures
Equipment and laboratory instrument qualification.
What to look for while doing a walk-through.
Other regulations and standards, including ISO 17025
Following through on the audit
Click here to register for this webinar
Who Will Benefit:
This webinar will be of benefit to company auditors who need to
investigate the qualifications of contract testing laboratories and
internal testing facilities. It will also be beneficial to workers in
laboratories that will be audited or inspected by external parties.
Personnel from companies that perform testing on small molecule
drugs, biologicals, and nutraceuticals will benefit from knowing what
standards are being applied to them.
The following specific types of workers will benefit from this webinar:
External and Internal Auditors
Supervisors and Analysts in Quality Control Laboratories and
Quality Assurance groups.
Supervisors and Analysts in Contract Testing Laboratories
Personnel Responsible for Selecting Contract Testing
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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