- Are
not “professional trainers” who simply read slides to you and have never actually
completed the work they are teaching.
- Are highly
knowledgeable clinical research trial professionals who have extensive training experience.
- Are
actively involved in the clinical research industry as auditors, consultants, investigators,
speakers and writers.
Tamera Norton Smith, PhD, MT(ASCP), President, Senior
Consultant
Ms. Smith is a former award-winning FDA investigator who is an active auditor, consultant,
author and trainer throughout the pharmaceutical and medical device industries. Her more than 17
years’ experience in the clinical research industry has included inspecting IRBs, CROs,
Sponsors and Clinical Investigators, consulting, monitoring clinical trials and performing
sponsor audits. Ms. Smith provides clinical research training in several areas, including fraud
detection and prevention. Through her extensive experience in pursuing suspect data cases, she has
developed a unique skill-based program for detection and prevention of clinical research fraud and
misconduct. With more than 10 years of teaching experience, Ms. Smith brings an unparalleled level
of energy and enthusiasm for her subject matter.
Notable Achievements
- National and Regional Speaker for Association of Clinical Research Practices (ACRP)
- Speaker for Canadian and other North American Research Conferences
- Awarded for FDA casework related to Good Clinical Practices and Good Manufacturing
Practices
- Nationally recognized by the U.S. Department of Health and Human Services for her work in
biologics and GMP fraud detection
- Accomplished the first anti-tampering prosecution in the southeast United States
- Selected to train the FDA’s Center for Devices and Radiological Health Division, 2004 and 2005,
regarding current industry practices
- Achieved one of three cases necessary to support the nation's first National Blood Bank Consent
Decree
- Sponsored the First Joint White Collar Crime Symposium for Clinical Research Professionals,
2003
Melissa Pong, MS, CCRA, Compliance Director, Instructor, Sr. Auditor and
Consultant
Ms. Pong has over 15 years experience as a Clinical Research
Associate, Research Lab Technician, Instructor, Auditor, and Consultant with several large
pharmaceutical firms including Corus Pharma, Inc., ICOS Corporation, PAREXEL International, Abbott
Laboratories, Rush Cancer Institute and IIT Research Institute. Ms. Pong’s career achievements include managing and
auditing several clinical trials in many therapeutic areas including Ophthalmology, Urology,
Osteoarthritis, Oncology, Cardiovascular, Infectious Disease, OBGYN, Pain Management, and
Respiratory.
Deidra Poucher, BSN, RN, MSHS, CCRC, Regulatory Director, Instructor, Sr. Auditor
and Consultant
Ms. Poucher, BSN, RN, MSHS, CCRC and Regulatory
Director for Norton Audits is a Sr. Auditor, Instructor and GCP Specialist with seventeen years of
research experience as an international auditor, consultant, instructor, IRB member, study
coordinator and research nurse, plus sixteen years of nursing experience. Ms.
Poucher's experience includes IRB Surveyor, Adjunct Professor, ACRP Chair and Regulatory
Affairs. Ms. Poucher’s therapeutic experience includes cardiovascular, pain, radiology, ophthalmology,
oncology, vascular, hematology, CNS, immunology, infectious disease, musculoskeletal, urinary,
OBGYN, respiratory, organ transplant and critical care among others.
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