This FDA inspection webinar compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company.
Description
This presentation will also give information on what an inspector may be thinking during the interview process.
FDA on-site inspections cause a great deal of worry for drug, biologics, and device companies in addition to contract laboratories. Many companies spend significant hours devoted to practicing mock inspections and training for real inspections. This presentation compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company.
This presentation will also give information on what an inspector may be thinking during the interview process. In addition, it offers tips for company personnel in answering inspector's questions, behavior during an inspection, and the requirements for managing an inspection outcome.
Areas Covered in the seminar:
* Update on FDA Inspections and Trends.
* Types of Inspections.
* The Inspection Process.
* Best Methods for a Smooth Inspection.
* Roles and Responsibilities.
* Recommendations for the Closeout Meeting.
* 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