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Kastango Consulting Group – Meet the Team

Mary Nazzal, PharmD, BSCSP

Mary Nazzal, a PharmD, Registered Pharmacist, is the Director of Field Operations for KCG.

She received her PharmD degree from Butler University of Indianapolis and has completed the Nuclear Pharmacy Certificate Program at Purdue University. Mary received her Compounded Sterile Preparations Certification from the Board of Pharmacy Specialties in the fall of 2019 as a member of its inaugural class.

She has over 14 years of progressive and diverse hospital pharmacist experience, including administrative, inpatient pharmacy, de-centralized pharmacy, and operating room with a focus in sterile compounding. Before joining KCG in 2017, Mary established and led sterile compounding services, including pharmacy-related policy/procedure/SOP development, technology setup and implementation, training development, and execution for Cleveland Clinic, Abu Dhabi in the United Arab Emirates. She performs gap analysis, facility design development, and review of construction documents for clients to ensure regulatory compliance as well as provide best practice recommendations regarding sterile compounding. She is also a member of the American Society of Health-System Pharmacists (ASHP) and Indiana Pharmacists Association.




Mark Bodnar, RPh

Mark Bodnar, BS Pharm, Registered Pharmacist, Rutgers University alumni is Director of Special Projects for KCG, with over 40 years’ experience in sterile compounding: hospital, infusion therapy/home, and LTC as well as FDA-regulated outsourcing facilities.

Mark’s focus through the years has been the introduction and installation of GCP/GMP culture through quality systems management of SOP development, documentation, training, and CAPA. Mark performs construction document reviews to ensure regulatory compliance and recommends best practices for sterile compounding. He is also a peer reviewer for gap analysis, facility design development, and other related documents. Mark is likewise a Rutgers University preceptor for IPPE and APPE pharmacy students during their rotation cycles and is involved with various medical device studies related to sterile compounding.

 

 

Kimberly Coughlin, B.S., RCP-SCF, NSF-49

Kimberly currently serves as the Director of Microbiology for KCG, joining in early 2019.

In her role, she provides consultation on environmental monitoring, remediation, and facility design performance. Kimberly is also responsible for reviewing regulatory compliance and performing onsite gap analysis at client facilities and audits of client vendors.

Kimberly has over 20 years of experience in microbiology laboratory testing, environmental monitoring, field testing, and certification of engineering controls in the pharmaceutical, medical device, research, and sterile compounding industries. During Kimberly’s industry tenure, she has worked with clients to develop meaningful environmental monitoring programs and successful remediation plans and has consulted on remedial efforts for engineering control performance issues.

Since 2015, Kimberly has served as a Director on the Controlled Environment Testing Association (CETA) Board of Directors. She is the 2019–2021 President-elect for CETA and Program Chair for the 2020 and 2021 annual meetings. Kimberly also serves as a subject matter expert (SME) for the CETA National Board of Testing’s (CNBT) Registered Certification Professional — Sterile Compounding Facilities (RCP-SCF) accreditation program. She served as the past Chair/Board Liaison of the CBNT Executive Committee and continues to serve as a committee member. She held a lead role in the writing of ISPE’s Good Practice Guide: HVAC and Process Equipment Air Filters. Kimberly received her Bachelor of Science degree in Environmental Science from Westfield State College. She received NSF Accreditation for the Field Certification of Class II Biosafety Cabinets and CETA accreditation as a Registered Certification Professional — Sterile Compounding Facilities.




 

Adam West, RCP-SCF, NSF-49

Adam West is the Environmental Monitoring and Training Specialist at CriticalPoint, LLC, a health-care training and development company.

In his current role, 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. He also works with KCG, providing consulting for environmental monitoring investigations and remediation, facility design, and certification of primary and secondary engineering controls for sterile compounding facilities.

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. In addition to certification, he has extensive knowledge in viable environmental monitoring, including sampling plan development and remediation, and has provided consultation services for USP Chapter 797 and 800 facility design compliance. Adam holds the Registered Certification Professional – Sterile Compounding Facilities (RCP-SCF) certification and NSF-49 accreditation.

 

 

Melanie Dorey, RPhT, QP503A

Melanie Dorey, RPhT, is licensed in Canada as a Pharmacy Technician. She graduated from La Cite Collegiale in 2006 from a two-year pharmacy technician program that is specialized in sterile compounding.

She has been working as a technician at a pediatric hospital since 2006. Melanie also has served as an aseptic teacher (practical and theory) at an accredited pharmacy technician college in Ottawa since 2010. Melanie has been working with CriticalPoint since 2015. She is currently the lead Aseptic Instructor at CriticalPoint and runs a one-and-a-half-day class that includes lectures and hands-on learning and competencies in aseptic technique. Melanie is QP503A certified and serves as a subject matter expert for CriticalPoint for other areas such as nonsterile compounding development of standard operating procedures and eLearning, pharmacy math, hazardous compounding, video shoots, and editing as well as eCurriculum development. She also works with CriticalPoint’s sister company, KCG, as an aseptic consultant and offsite speaker. She travels to different sites to offer hands-on training and lectures on many different 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. She also assists facilities with developing and completing evaluations/competencies. Melanie has performed a variety of roles at the pediatric hospital. These roles include tech check tech, IV room lead, critical care technician, writing and reviewing standard operating procedures, medication reconciliation, pharmacy buyer, billing, research/study technician as well as performing as a preceptor to new employees. She has voluntarily joined NAPRA on a Review Committee for Compounding Competencies. Melanie has a passion for sharing knowledge and loves teaching the “why” behind the “how.”