Managing GLP Studies in Non-GLP Facilities

Why Should You Attend:

You should attend this webinar if you or your organization conduct several types of studies at once, some of which are submitted to a regulatory agency. Very few organizations can afford the expense of having separate people, equipment, and space dedicated to GLP studies and non-GLP studies. Most companies, contract labs, and universities conduct both GLP and non-GLP activities simultaneously. Fortunately, these “mixed laboratories” have become increasingly common and various approaches have shown to be successful in managing both types of studies.

If you work on GLP studies or on non-GLP basic or exploratory research in a mixed lab, this seminar teaches you the best ways to keep the activities separate and meet GLP requirements. It alerts you to the main ways that other facilities have made mistakes in trying to keep activities separate. It also teaches you how equipment and personnel can overlap in the correct way to meet everyone’s expectations, i.e., a researcher’s as well as a regulatory agency. The goal of this webinar is to eliminate the possibility of study contamination so that your GLP study will not be invalidated.

Learning Objectives:

• Organizational separation of GLP and non-GLP activities
• Basic information non-GLP personnel must learn
• Physical separation of GLP and non-GLP equipment, reagents, and space
• What to do when things go wrong

Areas Covered in the Webinar:

• Defining non-GLP activities
• Knowing when certain activities must be conducted under GLP regulations
• Basic training for non-GLP personnel
• Methods for keeping non-GLP items separate from GLP items
• How to share equipment and logbooks
• Organization charts of mixed laboratories
• The Final Report’s Compliance Statement

Who Will Benefit:

• Scientists trained to participate in GLP studies
• Lab managers
• University researchers
• Grad students conducting research in a GLP lab
• QA professionals
• Study directors

Anne E Maczulak
Principal Consultant, Acorn GLP Consulting

Anne Maczulak, PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with established companies, startups, and universities in need of guidance in GLP regulations. She has presented webinars for FDA and training courses for the Society of Quality Assurance. She audits laboratories that conduct nonclinical studies and/or bioanalysis and provides on-site as well as remote training in GLP.

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