Posted on July 19, 2017
Under USP Chapter <797>, environmental and personnel sampling excursions which include exceeded action levels or the recovery of organisms of concern must be investigated. Requirements for this investigation and the essential remediation following the excursion are ambiguous, but inspectors expect documentation detailing the root cause of the excursion and the steps taken to prevent recurrence. Including a review of the historical data and other key components in the investigation will ensure the remediation steps taken are appropriate. Proper remediation is crucial in confirming the cleanroom has returned to a state of control, or that personnel are using proper techniques. Commitment to a proper investigation and remediation efforts will help ensure a safer compounded sterile preparation.
Webinar attendees will:
About the Presenters
Abby Roth is the Director of Microbiology at Clinical IQ LLC, a health care consulting firm. She holds a Certified Manager of Quality/Organizational Excellence certification through the American Society of Quality. Abby has more than 13 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring, including program development, sampling technique, sample analysis and data trending, as well as product testing. Abby also has experience in consulting on microbial contamination sources and remediation. She is currently serving as an expert committee member of the 2015 to 2020 USP Sterile Compounding Committee. Abby is an involved member of the Controlled Environment Testing Association (CETA), speaking at their annual meeting and teaching CETA series.
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP is president of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company. Eric received a coveted ISMP Cheers Award in 2015 for his work related to sterile compounding safety. He is one of four recipients of the 2013 Outstanding Service Award from the Massachusetts Society of Health-System Pharmacists and the 2014 recipient of the NABP Henry Cade Memorial Award that recognized his efforts and assistance to the states and NABP to address the compounding tragedy that occurred in 2012.