Best Practices in GLP Final Reporting and Study Closure

Areas Covered in the seminar:

• A description of a GLP final study report.
• Reporting requirements.
• Problems the FDA always sees.
• The QC process.
• Closing a study, step-by-step.
• Study amendments.
• Proper chain of custody and archiving.

Who Will Benefit:

This webinar provides final report writing background to people new to FDA requirements in GLP studies or as a refresher for personnel that have experience in GLP. It describes key points in report writing that often go overlooked. It also describes the closeout process in terms of QA, study director, principal investigator, management, and sponsor responsibilities.

• Test facility managementt
• Study directors
• Principal investigators
• Contract laboratories
• QA representatives
• Sponsor companies

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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