What We Can Learn From Warning Letters

Why Should You Attend:

Perhaps the best training in Good Laboratory Practices comes from studying the areas that regulatory agencies cite as GLP infractions. Many areas seem to be repeatedly cited each year. These are good starting points for learning "what not to do wrong" and for building a sound quality program. Warning letters are made public under the freedom of information act. Therefore, any company should learn the major citations found by the FDA for two reasons: (1) to avoid making the same mistakes in your study and (2) to avoid having your company’s name publicly cited for inspection findings. In addition to the Form 483 and warning letter process, the FDA inspection itself is described.

Areas Covered in the Webinar:

• What is a Form 483 and how can it be avoided.
• What is a warning letter and how can it be avoided.
• What are a main findings that initiate warning letters each year.
• The proper way to respond to inspection findings.
• The proper way to host a regulatory inspection.
• Where to find warning letters on the Internet.

Who will benefit:

This webinar is targeted to scientists and management new or experienced in GLPs. This includes established companies, startups, and university laboratories conducting sponsored regulated studies. The following individuals will benefit from the information in this webinar:

• QAU and company QA managers
• Testing facility management
• Study directors
• Consultants
• Auditors

Instructor Profile:

Anne E. Maczulak, is Principal Consultant of Acorn GLP Consulting, based in the San Francisco Bay Area. She provides FDA and EPA Good Laboratory Practice compliance audits, training, and guidance to large and small companies in pharmaceuticals, devices, biotechnology, and chemicals. She has also provided GLP guidance for university-based studies. Acorn GLP Consulting specializes in helping companies and university laboratories new to preclinical studies build strong quality assurance and GLP programs from the ground up.

Anne worked in industry for 20 years at pharmaceutical and consumer products companies. During that time she served as a GLP sponsor, study director, and participating scientist.

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