FDA at the Door: Ten Essential Steps for Inspection Success

FDA on-site inspections can be cause for a great deal of worry for drug, biologics and device companies, and with good reason. If an inspection does not go well, the FDA will start out by demanding changes in the company’s practices with a Form 483, and continue by issuing a warning letter if these demands are not met. Many companies spend long hours preparing for inspections with mock inspections. However, it can be difficult to know exactly what to expect.

This FDA Inspection training brings a large amount of information together in one place to give you somewhere to start. It will show you tried and true methods for satisfying FDA inspectors, with tips for the interview process, behavior during an inspection, and how to manage an inspection’s outcome. Targeted at company management, QA, and personnel with little or no experience in FDA inspections, this training will guide you through the daunting task of preparing for an FDA inspection.

Areas Covered in the seminar:

• The latest updates on FDA inspections and trends.
• The various types of inspections.
• The Inspection Process.
• The best ways to ensure a smooth inspection.
• Roles and Responsibilities.
• Recommendations for the Closeout Meeting.
• What to do after the inspection team leaves.

Who Will Benefit:

This webinar targets company management, QA, and personnel with little or no experience in FDA inspections. This webinar provides information to help make inspections less of a stressful event, but rather a powerful learning experience for future activities. Companies, contract facilities, and university laboratories will benefit from the information presented in this webinar, specifically:

• Company management
• University study management
• Study personnel
• QA representatives
• Legal departments

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. Anne’s background is in microbiology, so in addition to QA, she is often called upon to provide consultation in the areas of environmental monitoring and development of HACCP programs.

Anne’s experience in quality assurance training includes presentations at the Society of Quality Assurance training workshop and the SQA Pacific Chapter’s annual training conferences in addition to other association conferences. As an independent consultant, Anne offers companies training in the following: introductory GLP training, study director and management responsibilities, good documentation, and effective SOP writing. Anne Maczulak is a published author; her consulting services include technical writing. In addition, Acorn GLP Consulting tailors all of its training courses to the specific needs of the company or laboratory.

Anne Maczulak is currently treasurer and board member of the Pacific Regional Chapter of SQA, a member of the national SQA, and a member of the Regulatory Affairs Professionals Society. She serves on SQA’s specialty committees on biotechnology and on university-based studies.

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