Denise Frank RPh
Director of Accreditation and Inspection Services
Denise is a pharmacist and an independent consultant with extensive experience in pharmacy practice and expertise in accreditation and regulatory compliance. She served as a member of the Minnesota Board of Pharmacy for eight years and participatedin National Association of Boards of Pharmacy (NABP) committees for almost 20 years. She also served as a surveyor consultant and Accreditation and Inspection Services manager for NABP.
Furthering our commitment to the actual operations of the pharmaceutical supply chain, our Advisory Board is comprised of members with experience and expertise in the following areas: Manufacturing, Distribution, Pharmacy/Healthcare provider, and Legal/Regulatory (FDA, DEA, Board of Pharmacy, Attorney, Consultant).
Donnie Calhoun, BPharm, FACA, FACVP attended Troy State University earning a B.S. degree in Biology and then attended Samford University in Birmingham, graduating in 1987 with a B.S. degree in Pharmacy. Calhoun is a licensed pharmacist in Alabama and has owned several pharmacies during his career. He is the current owner of Calhoun Compounding Pharmacy in Anniston, Alabama. He is Past President of the National Community Pharmacists Association, Past President of the National Community Pharmacists Association Foundation, Past President of the Alabama Board of Pharmacy, Past Executive Director of the Specialty Sterile Pharmaceutical Society, and he has held many positions with the Alabama Pharmacy Association. He is also a former CEO/Executive Vice President for the American College of Apothecaries, the American College of Veterinary Pharmacists and the American College of Apothecaries Research and Education Foundation. Donnie was elected to the Pharmacist Mutual Board of directors in 2005.
Drug Distribution Industry
Sid Geller is an experienced supply chain professional, with expert knowledge in the areas of profitability, negotiating Fee-for-Service agreements, forecasting, trade relations, 3PL selection and assisting new start up branded and generic companies in bringing their products to market. At Cardinal Health, Sid was responsible for achieving the annual buy-margin. Sid has negotiated over three hundred Fee-for-Service agreements with leading pharmaceutical companies and managed, trained and mentored over two dozen people who currently hold key executive level positions with various pharmaceutical companies.
Legal / Regulatory
Rick Lauer, Esq.
Rick Lauer has represented various healthcare entities for over a decade. He has provided trusted legal counsel to manufacturers and distributors of prescription drugs and medical devices, pharmacies and logistics providers. He has extensive experience dealing with the FDA, DEA and state boards of Pharmacy. He has successfully counseled both buyers and sellers of healthcare entities in mergers and acquisitions.
Brian Rucker is a consultant for the pharmaceutical industry, specializing in top to bottom reviews of manufacturers’ and wholesalers’ controlled substance due diligence/know your customer programs, suspicious order monitoring techniques, audit methodology, and security controls and procedures. Previously, Brian was the Director of Compliance for Independent Pharmacy Cooperative (IPC) from September 2013 to April 2018. Assigned to the Phoenix office, he was responsible for implementing and managing IPC’s controlled substance program. Prior to IPC, Brian was employed for over 34 years with the U.S Government, serving over 14 years with the Drug Enforcement Administration and 20 years as a Naval Officer with the United States Navy. He Retired as a Commander from the Navy Reserves in 2000 and from the DEA in August 2013.
QAS Accreditation Surveyors are either licensed pharmacists or have at least 10 years of experience specifically in wholesale drug distribution (experience may be derived from a regulatory agency or from industry). We also provide an Inspection program – our inspections are only performed by licensed pharmacists.
Results-oriented law enforcement professional with over 25 years of experience acting as a Special Agent for the FDA to investigate fraud and lead surveillance efforts related to GMP fraud, counterfeit drugs, medical device manufacturing fraud, clinical trial fraud, and fraud related to false NDAs. Proven track record of protecting executives/organizations from deviations from GMP, fraud, theft or damage. A skilled problem-solver with strong leadership and investigation skills. Able to sustain a high level of professionalism and confidentiality.
Drug Distribution Industry
Kenton (Kent) Nagel
Kenton (Kent) Nagel is recognized as a trusted leader to analyze issues, develop and motivate teams to successfully implement customer-centric and regulatory compliant solutions. He has held key management positions since 1991, with his most recent position being Vice President of Operations for Metro Medical Supply and Cardinal Health Specialty Solutions. Kent’s accomplishments include regulatory certification and compliance, product inventory control, ERP systems requirement blueprinting and profit/loss management. He recently implemented process changes that exceeded the stringent guidelines introduced in the FDA’s DQSA (Drug Quality and Safety Act) with WHO (World Health Organization) requirements. Kent is known as a solution provider through listening and applying his vast industry knowledge, natural ability to cut through the noise to identify root causes when facing issues or addressing growth challenges. Kent maintains current certifications in Florida and California for the pharmaceutical designated representative demonstrating his advanced understanding of Pharmaceutical and Medical Device regulations.