Western National is a super-regional carrier with well-diversified geographic representation and product risk
spread, as the group underwrites a variety of commercial and personal lines products in 20 states.
* Karen's experience is in performing human factors activities throughout the development process, including: ethnographic research, translating stakeholder needs into measurable, technical requirements, facilitating creative workshops, assessing product risk
, and designing, conducting and analyzing Formative and Validation usability studies.
While a drug substance risk assessment is not a required element of the Q3D guideline, the assessment of the drug substance and its potential contributions to the drug product elemental impurity burden is an essential part of the drug product risk
Revision D includes additional requirements for product risk
systems, traceability and mitigating counterfeit parts.
During his tenure at the company, Freitag was also vice president of product risk
and profitability management for the Individual Life and Annuities businesses.
Overall, the CAPA must link to product risk
Although future catastrophic liability claims and class action lawsuits may emanate from any emerging product risk
, the potential could be greater when novel technologies with unknown risks emanate from an industry that "touches" consumers as closely as food packaging.
Second, when consumers misperceive risk, only strict liability is efficient because firms (which are assumed to perceive risks accurately) will set a price that correctly conveys product risk
to consumers, so they will purchase the correct amount, and firms, because they bear the full damages from any accidents, will invest in efficient safety.
The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk
, " said Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.
The report, "Insurance Product Risk
in the GCC", is now available on
We build upon this literature in two ways: in the way risk is modeled (considering asset risk, product risk
, and financial risk, i.e., leverage, following Baranoff and Sager, 2002) and in the methodology employed (use of structural equation models following Baranoff, Papadopoulos, and Sager, 2007).