Abby Roth, CMQ/OE

Abby’s lab experience started in 2004 and continued through 2017, where she held the role of Quality Director at a contract pharmaceutical microbiology laboratory. To improve her quality knowledge base, she holds the Certified Manager of Quality/Organizational Excellence certification through the American Society of Quality. Prior to founding Pure Microbiology in 2022, she was a subject matter expert for CriticalPoint LLC, a health care training and development company. In addition to operational responsibilities, she developed curricula for educational sterile compounding products. Abby was also a consultant for Clinical IQ, serving as their Director of Microbiology.

Abby’s passion for sterile compounding started in 2008 when USP Chapter <797> introduced the requirement for viable air and surface sampling. This passion really blossomed in 2015 when she had the honor of serving as an expert committee member for the USP Compounding Committee for the 2015 to 2020 cycle. She is an involved member of Controlled Environment Testing Association (CETA), serving on their Board of Directors, speaking at their annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby 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).

Patricia Clancy Kienle, RPh, MPA, BCSCP, FASHP

Patricia Kienle is the Director of Accreditation and Medication Safety for Cardinal Health.

She received her pharmacy degree from the Philadelphia College of Pharmacy and Science and a master’s in Public Administration from Marywood University in Scranton, Pennsylvania. She is board certified as a Sterile Compounding Pharmacist, completed an executive fellowship in Patient Safety from Virginia Commonwealth University in Richmond, Virginia, and is an Adjunct Clinical Faculty member at Wilkes University in Wilkes-Barre, Pennsylvania.

She served on the Board of Directors of the American Society of Health-System Pharmacists and as President of the Pennsylvania Society of Hospital Pharmacists. She is a Fellow of ASHP, was named Pharmacist of the Year by PSHP, the recipient of the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management, the Distinguished Leadership Award from ASHP, the ASHP John W. Webb Lecture Award, the Thomas S. Foster Award from the United States Pharmacopeia, the Lifetime Achievement Award from the Institute for Safe Medication Practices, and ASHP Harvey A.K. Whitney Lecture Award. She has served on the Pharmacotherapy Specialty Council of the Board of Pharmacy Specialties, the Pennsylvania Patient Safety Authority, the Hospital Professional and Technical Advisory Committee of The Joint Commission, and on the Board of Governors of the National Patient Safety Foundation. She is a current member of the USP Compounding Expert Committee.

Patti is the author of The Chapter <795>; Answer Book, The Chapter <797>; Answer Book, The Chapter <800>; Answer Book, and co-author of Meeting Accreditation Standards: A Pharmacy Preparation Guide.

With over 600 invited presentations and 100 publications, she has special interests in promoting medication safety, compounding sterile preparations, accreditation, and regulatory issues.

Kevin N. Hansen, PharmD, MS, BCSCP

Kevin N. Hansen, PharmD, MS, BCSCP is a distinguished expert in pharmaceutical compounding with over 15 years of experience in health-system pharmacy operations. He has a profound interest in patient safety and drug shortage mitigation, and he is renowned for his successful implementation of compounding technology and automation, particularly a centralized IV sterile compounding robot operation at a large health system.

Dr. Hansen’s expertise extends to designing cleanroom suites for USP <797> and <800> compliance, and he has designed over 10 such facilities. He is a board-certified expert in compounded sterile preparations through the Board of Pharmacy Specialties, and he completed a PGY1/PGY2 Health-System Pharmacy Administration and Leadership residency program at the University of North Carolina Medical Center. Dr. Hansen earned his Doctor of Pharmacy degree from Lake Erie College of Osteopathic Medicine (LECOM) and a Master of Science degree in Pharmaceutical Sciences with a specialization in health-system pharmacy administration from the UNC Eshelman School of Pharmacy.

In addition to his professional accomplishments, Dr. Hansen serves as adjunct faculty for the UNC Eshelman School of Pharmacy, where he imparts his knowledge and expertise to aspiring pharmacy leaders. He is also currently serving as an expert volunteer on the United States Pharmacopeia (USP) Compounding Expert Committee. Dr. Hansen is a proven leader and is passionate about leading multidisciplinary teams to achieve success in health-system pharmacy operations.

Lew exner

A Navy veteran and a seasoned trainer and leader, Lew brings over 30 years of experience specializing in cleanroom and containment device certification. He has held several accreditations with NSF, NEBB, and CETA. Lew started as a field technician and made his way up to become a Certification Division Manager, managing over 35 employees. He was instrumental in developing a Cleanroom Technician Training program and has performed thousands of airflow visualization smoke studies in both Pharmaceutical (cGMP) and Pharmacy (503A and 503B) clients.

Lew is currently the Director of Field Operations at Controlled Environment Consulting (CEC) overseeing the certification service and training operations. Over the course of his career, he has become a well-known and respected consultant for certification and validation environments. Lew has presented several classes designed to enhance the general certification knowledge for the FDA and has been an instructor for “Testing HEPA Filtered Systems and Pharmaceutical Cleanrooms” at the Eagleson Institute since 2003.

Lew served on the Controlled Environment Testing Association (CETA) Working Group for the Ceta Application Guide (CAG-008). Lew has served on the Controlled Environment Testing Association, (CETA) Board of Directors since 2021 and was President of CETA for the 2024 – 2025 term.