ComplianceOnline

Auditing Analytical Laboratories for FDA Compliance

Instructor: Steven S Kuwahara
Product ID: 700870
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2008

Training CD / USB Drive

$500.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This presentation will discuss the advance preparation that is needed on the part of the auditor, and discuss the things that the auditor should look for during the audit.

Description

It will also be beneficial to workers in laboratories that will be audited or inspected by external parties.

Auditing analytical laboratories can be a complex affair because of the preparation that is often required. Not all of the GMP rules 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 be confused about what regulations apply to the work that is being conducted. This presentation will discuss the advance preparation that is needed on the part of the auditor, and discuss the things that the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be presented.

Areas Covered in the seminar:

  • GMP regulations that apply to analytical laboratories.
  • Other regulations and standards, including ISO 17025.
  • Advance preparation for the audit.
  • Auditing styles and structures.
  • Equipment qualification.
  • Doing a walk-through and what to look for.
  • Reviewing documentation.
  • Follow through on the audit.

Who will benefit:

This webinar will be of benefit to company auditors who will need to investigate the qualifications of contract testing laboratories and internal test facilities. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties. Personnel from companies that must perform testing on small molecule drugs, biologicals, and nutraceuticals will benefit from knowing what standards are being applied to them.

  • External and Internal Auditors
  • Supervisors and Analysts in Quality Control Laboratories
  • Supervisors and Analysts in Contract Testing Laboratories
  • Personnel Responsible for Selecting Contract Testing Laboratories
  • Consultants

Instructor 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 GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories and in performing GMP audits of internal and external testing laboratories. He has performed audits of contract testing laboratories and performed evaluations of R & D laboratories and GLP testing laboratories.

Follow us :
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
Seminars by Ex-FDA Officials

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

I work for a commercial testing lab firm who has one lab complying with GMP we have several others who are interested in upgrading their quality programs to meet GMP requirements. The webinar was helpful in that it confirmed our auditing approach while explaining a few of the specific GMP areas that I do not deal with routinely.
- Anonymous

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