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CriticalPoint has teamed with international experts to bring you a state-of-the-art Sterile Compounding curriculum, training, and resources. These experts not only talk about these principals but have also put these practiced principals to use while working in their own cleanroom environments. We believe this practical, hands-on perspective is a critical differentiator. Please review our authors’ CV’s for additional information.
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, is president of Kastango Consulting Group (previously Clinical IQ LLC), a health care consulting firm and CriticalPoint, LLC, a web-based education company.
Mr. Kastango received his Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and his Master of Business Administration degree from the University of Phoenix. He completed 65 hours of training in nuclear pharmacy at Purdue University and 80 hours of didactic training for the Six Sigma-Green Belt certification that he started with BD Medical Systems.
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.
Since 1980, he has practiced pharmacy in a number of practice settings, including hospitals, community, and home care, in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation.
He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from 2005-2010 and 2010-2015 USP Council of Experts, Compounding Expert Committee until April 2013. In May 2013, USP recognized Eric and the members of Compounding Expert Committee with an Award for Outstanding Contribution to the USP Standards-Setting Process.
He has served on the USP Hazardous Drug Expert Panel since 2010. He is actively working with NABP and state boards of pharmacy to provide training to their sterile compounding inspectors. Eric served on the Expert Panel for ASHP Research & Education Foundation in the development of the 2015 Outsourcing Sterile Products Preparation Vendor Assessment Tool and ASHP’s Insourcing Readiness Assessment Tool.
He is also the author of the 2004 ASHP Discussion Guide on Sterile Preparation: Summary and Implementation of USP Chapter 797, the ASHP Sterile Product Preparation CD-ROM: A Multimedia Learning Tool, the ASHP web-based 797 Compliance Advisor Gap Analysis Tool for USP Chapter 797. He assisted in the development of the CriticalPoint web-based educational series on Sterile Compounding and the Annual National USP <797> Compliance Survey now in its fifth year. Eric has over 200 invited national and international professional presentations on various pharmacy practice topics such as pharmacy compounding, patient safety and quality systems.
Patricia Kienle, RPh, MPA, BCSCP, FASHP is the Director of Accreditation and Medication Safety for Cardinal Health. Patti has presented over 500 talks on medication safety, compounding, regulatory, and accreditation issues. She is the author of The Chapter <795> Answer Book, The Chapter <797> Answer Book, and The Chapter <800> Answer Book and co-author of Meeting Accreditation Standards: A Pharmacy Preparation Guide. Patti is a member of the USP Compounding Expert Committee.
Melanie Dorey, RPhT, is the Compounding Learning and Product Specialist with CriticalPoint, LLC and licensed in Canada as a pharmacy technician. She graduated from La Cite Collegiale, completing a two-year pharmacy technician program that specialized in sterile compounding. Since 2006, Melanie has worked as a technician at a pediatric hospital, performing a variety of roles that include tech check techician, IV room lead, critical care technician, writing and reviewing standard operating procedures, medication reconciliation, pharmacy buyer, billing, and research/study technician as well as a preceptor to new employees. Since 2010, she has served as an aseptic teacher (practical and theory) at an accredited pharmacy technician college in Ottawa. Melanie has been with CriticalPoint since 2015, serving as one of its faculty experts for the hazardous and nonhazardous sterile compounding curriculum and the lead aseptic instructor. She is QP503A certified and serves as a subject matter expert for CriticalPoint in other areas such as nonsterile compounding development of standard operating procedures and eLearning, pharmacy math, hazardous compounding, and video recording and editing as well as eCurriculum development. Melanie also works with CriticalPoint’s sister company KCG as an aseptic consultant and speaker. She travels to multiple sites offering hands-on training and lectures on many subjects, including cleaning, disinfecting, aseptic technique, hand hygiene and garbing, environmental monitoring, and compounder conduct. Melanie shares knowledge and theories to help make improvements in current work practices and also assists facilities with developing and completing evaluations and competencies. She is a member of the Review Committee for Compounding Competencies for NAPRA. Melanie has a passion for sharing knowledge and loves teaching the “why” behind the “how.”
Mary Nazzal, PharmD, is the Director of Field Operations for Kastango Consulting Group. She received her PharmD degree from Butler University of Indianapolis and has completed the Nuclear Pharmacy Certificate Program at Purdue University. She has over 14 years of progressive and diverse hospital pharmacist experience including administrative, inpatient pharmacy, de-centralized pharmacy, operating room with a focus in Sterile Compounding. Prior to joining Clinical IQ in 2017, Mary established and lead Sterile Compounding Services including pharmacy related policy/procedure/SOP development, technology setup and implementation, training development and implementation for Cleveland Clinic, Abu Dhabi in the United Arab Emirates.
Abby Roth is the Senior Director of Business Operations at CriticalPoint, LLC, a healthcare training and development company. In addition to operational responsibilities, she develops curriculum for CriticalPoint’s eLearning modules and live training classes. Prior to joining CriticalPoint, Abby served as the Director of Microbiology for Clinical IQ, LLC, and as Quality Director at a contract pharmaceutical microbiology laboratory.
She has over 17 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 and product testing. Abby also has experience in consulting on microbial contamination sources and remediation. She holds the Certified Manager of Quality/Organizational Excellence certification through the American Society of Quality.
Abby served as an expert committee member for the USP Compounding Committee from 2015 to 2019 and is an involved member of Controlled Environment Testing Association (CETA), speaking at their annual meetings and chairing committees for the revision of three CETA Application Guides. She has been invited to speak for state boards of pharmacy and for organizations such as the National Home Infusion Association (NHIA) and the American Society of Health-System Pharmacists (ASHP).
Adam West is the Environmental Monitoring and Training Specialist at CriticalPoint, where he is responsible for the development and delivery of live face-to-face, virtual, and eLesson curriculum related to aspects of primary and secondary engineering controls and certification.
Adam has over ten years of experience in the certification industry providing Field Certification Services for 503A and 503B sterile compounding facilities and pharmaceutical and medical device manufacturers. Adam also has expertise in viable environmental monitoring, including sampling plan development and remediation. Adam holds the Registered Cleanroom Certification Professional – Sterile Compounding Facilities (RCCP-SCF) certification and NSF-49 accreditation.