Learning from Laboratory-related FDA Warning Letters

While we cannot be present at FDA inspections of other companies, we can review the individual citations (483's) that are issued by FDA investigators and learn from them. The website for warning letters is open to all and by routinely reading warning letters we can learn about the problems that FDA sees and sense changes in the emphasis of their inspections. This presentation will cover laboratory-related warning letters that contain 483s related to regulatory issues that affect pharmaceutical companies. While recent warning letters will receive the heaviest scrutiny, we will also cover old warning letters that serve to illustrate important points.

Areas Covered in the seminar:

• The will start by showing participants how to access FDA warning letters, and how to navigate through the website to find useful letters.
• How to read warning letters.
• Documentation issues.
• Management issues
• Laboratory activities that create problems.

Who will benefit:

This presentation will be aimed at QA and QC laboratory personnel and those who supervise them.

• Manufacturing personnel who must use laboratory data for controlling processes.
• Technical auditors who go to contract testing laboratories.
• Personnel who perform "due diligence” audits of laboratories who seek an association.
• Consultants who work with laboratories.

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 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. He has participated in the product development process for small molecule drugs and biologics, and has prepared or reviewed many CMC sections.

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