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Kate Douglass, MS, RN, CRNI, Vice-President, CriticalPoint, LLC
Kate Douglass, MS, RN, CRNI is Vice-President of CriticalPoint, LLC, a healthcare training and development company. She is a co-author of CriticalPoint’s Interactive USP Chapter <797> Gap Analysis Tool and Co-Director of the annual USP 797 Compliance Study. Kate has written numerous articles on sterile compounding quality and training. She co-authored a paper commissioned by the Pew Charitable Trust titled “Quality Standards for Large-Scale Sterile Compounding Facilities” and is a member of the Sterile Compounding Boot Camp Faculty. Kate has personally supervised the design, engineering and build of pharmacy compounding facilities that met or exceeded USP requirements. She was the Project Manager for the design and build of CriticalPoint’s Center for Training and Research in Totowa, New Jersey.
Prior to joining CriticalPoint, Kate was the President of Performance Strategies, LLC, a company focused on best practice sterile compounding and drug administration assisting hospitals, alternate site, manufacturing, and commercial health care market segments. Kate has also served as the Senior VP of Clinical Operations for Coram Healthcare and as COO of SoluNet, LLC, a licensed pharmacy and FDA-registered manufacturer (later acquired by B. Braun’s CAPS) that provided CSPs to hospitals. Licensed as an Advanced Practice Nurse, Kate received her Bachelor of Science from Villanova University and a MS from Rutgers, The State University of New Jersey. She holds a post graduate Certificate in Advanced E-Learning Instructional Design and is currently pursuing training that will lead to CPLP (Certified Professional in Learning and Performance) certification. She serves on the Editorial Board of the Journal of Infusion Nursing.
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP, President, Clinical IQ, LLC
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.
James T. Wagner, President, Controlled, Environment Consulting
Jim Wagner, the president of Controlled Environment Consulting (CEC), has over 33 years experience assuring the performance of critical environments. His consulting includes design and evaluation of sterile compounding facilities, containment facilities and other engineering controls. Jim conducts international training on cleanroom and containment device certification. Prior to founding CEC, Jim was the President of Micro-Clean, a certification and validation company. Recently Jim led the Controlled Environment Testing Association’s (CETA) efforts to develop guidance documents for USP Chapter 797. He served on the USP sterile compounding expert committee for the 2005-2010 appointment cycle and is a member of the 2010-2015 USP Hazardous drug compounding expert committee. He has presented at many USP forums on engineering controls for sterile compounding. Jim is a steering committee member for NSF/ANSI standard 49 Biosafety Cabinetry: Design, Construction, Performance and Field Certification. He has been an NSF accredited BSC certifier since program inception in 1993. He is a current board member for the Controlled Environment Testing Association and served as president in 1992-1994 and 2006.
Brian Williamson, PharmD
Brian has been involved in many aspects of the pharmacy industry, including a role as a clinical pharmacist in a pediatric hospital, teaching pharmaceutical compounding, and the ownership and operation of a sterile compounding pharmacy. Most recently, Brian owned and operated a successful 503B Outsourcing Facility. Williamson is now consulting for and investing in various companies and opportunities in the pharmacy space.
Greg Rockers, RPh
Greg has over 14 years of sterile compounding experience in both pharmacy and manufacturing. He has operated two 503B Outsourcing Facilities and has assisted organizations in navigating multiple FDA inspections. Greg has considerable experience in all facets of running an FDA compliant compounding facility including formulation development, cGMP gap analysis and remediating 483 observations.
Lewis is employed by Controlled Environment Consulting (CEC) where he performs Gap Analyses as well as Construction Design Review for pharmacies that fall under the jurisdiction of the USP Chapters <797> and <800>. Prior to joining CEC, Lew was employed by Micro-Clean, Inc. for 25 years. During his tenure in the certification division, he managed over 30 employees conducting a variety of primary and secondary engineering control certification services.
Lew is also a tenured trainer participating in a variety of live training programs developed for pharmacies, FDA personnel as well as other certifiers. He lectures and demonstrates how to perform airflow visualization at the Eagleson Institute located in Sanford, ME.
Lew earned accreditation in NSF/ANSI Standard 49 in 1995 and he has achieved the National Environmental Balancing Bureau (NEBB) Certified Professional Status in Cleanroom Performance Testing in 2001.