Week 2 learning team

Topics: Food and Drug Administration, Administrative law, Regulation Pages: 6 (776 words) Published: May 24, 2014
University of Phoenix Material

Organizational Performance Management Table

After you have completed your individual research on your chosen type of health care organization, collaborate with your Learning Team to complete this table. Then, refer to this table as you collaborate to write your paper. Include this table as an appendix to your paper.

Fill in the necessary information in each cell, but be as succinct as possible.

1. Provide names of or links to specific organizations. Summarize key products or services provided by each type of organization and identify the primary customers they serve.

Organization One
Organization Two
Organization Three
http://www.fda.gov/
U.S. Food and Drug Administration

2. Outline the overall content of the major regulations, accreditation requirements, and other standards that affect each organization. Provide the title, section, parts, or subparts or the numbering system and so on of the specific regulations or accreditation requirements.

For example: Use of electronic signatures in electronic medical records is equivalent to handwritten signatures on paper; FDA regulation; Title 21 CFR Part 11, Subpart C, § 11.200 Electronic Signature: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11

Organization One
Organization Two
Organization Three
Food and Drug Administration Safety and Innovation Act (FDASIA) Because of their importance, an agency’s rulemaking plans are of great interest to a wide range to stakeholders. Therefore, the Federal Government publishes a semi-annual agenda of upcoming regulations in the Federal Register, usually in the Spring and Fall. As part of FDA’s Transparency Initiative and FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK), we are also providing periodic updates on FDA’s Unified Agenda rulemakings. On the Unified Agenda-TRACK Web page, we will maintain an updated agenda of FDA’s Unified Agenda rulemakings.

3. Highlight the effect of each organization’s regulations, accreditation requirements, and other standards on the risk- and quality-management functions and activities.

Organization One
Organization Two
Organization Three
The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.

In general, FDA regulates:

Foods, including:

dietary supplements
bottled water
food additives
infant formulas
other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products) Drugs, including:

prescription drugs (both brand-name and generic)
non-prescription (over-the-counter) drugs
Biologics, including:

vaccines
blood and blood products
cellular and gene therapy products
tissue and tissue products
allergenics
Medical Devices, including:

simple items like tongue depressors and bedpans
complex technologies such as heart pacemakers
dental devices
surgical implants and prosthetics
Electronic Products that give off radiation, including:

microwave ovens
x-ray equipment
laser products
ultrasonic therapy equipment
mercury vapor lamps
sunlamps
Cosmetics, including:

color additives found in makeup and other personal care products skin moisturizers and cleansers
nail polish and perfume
Veterinary Products, including:

livestock feeds
pet foods
veterinary drugs and devices
Tobacco Products, including:

cigarettes
cigarette tobacco
roll-your-own tobacco
smokeless tobacco

4. Specify components of performance-management systems—policies and procedures, self-audits,...
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