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A Certified
Product Safety Specialist (CPSS) is responsible for
minimizing the risks in the product safety industry by
identifying, screening, reviewing and reducing potential
problems. A CPSS can develop reports regarding damages and
injuries potentially caused by a product. The CPSS course
was designed to serve as a guideline for attorneys,
physicians, nurses, toxicologists, researchers, pharmacists,
pharmaceutical representatives, drug or product regulators
and those working in the pharmaceutical industry,
legal-medical industry or in drug or product manufacturing,
importing or exporting. With the many products that are
under scrutiny, the need for this type of new age specialty
is at its highest! |
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Strict liability |
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Products liability |
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Failure to warn |
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Manufacturing |
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Duty, breach of duty, damages/injuries, causation |
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Internet search: Medscape, MEDLINE, eMedicine, Drug
Reference |
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Food
and Drug Administration (FDA) |
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FDA compliance |
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FDA
approval |
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Clinical studies |
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Investigational new drugs |
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New
drug applications |
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Liability Prevention |
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Labeling |
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Drug warnings |
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Pharmaceutical advertising |
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Adverse drug reactions/adverse product reactions |
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Adverse Events |
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Trending |
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Toxic
Torts |
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Signaling |
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Code of Federal Regulations (CFR) |
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Risk
assessment – benefit/risk ratio |
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Risk minimization |
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Risk minimization action plans |
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Liability Detection |
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Consumer complaint calls |
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Basic
data entry |
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Demographics |
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Electronic Case Screening |
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Report
Writing |
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How to
use the computer to make reports |
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Preparation of exhibits/demonstrative evidence |
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Using databases/software to manage mass information |
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Electronic database report writing |
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Federal
acts |
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Standards/deviations |
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Legal
and ethical aspects |
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Conflicts of interest |
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Crime
Scene Reconstruction |
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Confidentiality |
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Fraud |
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