Auditing Analytical Laboratories for FDA Compliance

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.

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