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2-day In-person Seminar

Auditing Analytical Laboratories for FDA Compliance


November 20th & 21st, 2017

Time: 9:00 AM to 6:00 PM

Manila, Philippines

Venue: WILL BE ANNOUNCED SOON


Director : Dr. Steven Kuwahara

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,095.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $3,285.00
      $5,475.00 You Save: $2,190.00 (40%)*

  Register for 10 attendees   Price: $6,022.00
      $10,950.00 You Save: $4,928.00 (45%)*
Course "Auditing Analytical Laboratories for FDA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.


Who will benefit:

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 Laboratories
  • Consultants

Day 1 Schedule


Lecture 1:

GMP Regulations that Apply to Analytical Laboratories


Lecture 2:

Reviewing Documentation


Lecture 3:

Advance Preparation for the Audit


Lecture 4:

Auditing Styles and Structures



Day 2 Schedule


Lecture 1:

Equipment and Laboratory Instrument Qualification


Lecture 2:

What to look for while doing a Walk-Through


Lecture 3:

Other Regulations and Standards, including ISO 17025


Lecture 4:

Following through on the Audit

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven 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.





Location: Manila, Philippines Hotel: WILL BE ANNOUNCED SOON  

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