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, Instructor, Auditor, and
GCP Specialist
Ms. Pong has over 14 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.
|
