The Most Important Compliance Best Practices You Need to Know

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 is an amendment to the Federal Food, Drug, and Cosmetic Act. It requires that manufacturers clearly identify on the labels of food if it contains an ingredient that is or contains protein derived from a "major food allergen" declare the presence of the allergen in the manner described by the law.

The School Food Safety Program is based on the Hazard Analysis and Critical Control Point Principles (HACCP) established by the Secretary of Agriculture, U.S Department of Agriculture (USDA). HACCP implemented a legislative provision requiring school food authorities participating in the National School Lunch Program (NSLP) or the School Breakfast Program (SBP) to develop a school food safety program for the preparation and service of school meals served to children. It enables schools to take systematic action to minimize or prevent the risk of food-borne illness among children participating in the either program.

The U.S Department of Agriculture, through its Food Safety and Inspection Service (FSIS) has established January 1, 2014, as the uniform compliance date for new meat and poultry product labeling regulations that are issued between January 1, 2011, and December 31, 2012.

Uniform compliance dates are periodically announced to minimize the economic impact of label changes.

The Knox-Keene Health Care Service Plan Act (Knox-Keene Act) is a California law that provides the license and regulation of managed health care service plans. The design of the act provides for the regulation of health insurers by the Department of Insurance. The licensure and plans' compliance with state regulations is managed by the Department of Managed Health Care.

Banks are failing at an alarming rate and the number of problem banks continues to rise. Shareholders and taxpayers are shouldering the brunt of the losses and, as a matter of recourse, the FDIC and shareholders groups are suing the directors and officers of failed banks for negligence and mismanagement. In order to provide protection against the risk taking that has led to failed bank litigation, financial institutions must take sufficient steps to manage and mitigate the human factor risks that have contributed to the crisis.

Author Profile:

Tyler D. Nunnally is the Founder & CEO of Upside Risk Corporation, a behavioral risk management consultancy that helps organizations to maximize profit while mitigating risks inherent in human judgment. He currently serves on the Board of Directors of the Technology Association of Georgia (TAG) International Business society.

 

The present article delineates Judgment Risk Indicator which is a behavioral -based risk assessment that enables clients to gain strategic and competitive advantages by identifying and developing top talent. It also provides the JRI snapshot report to help clients making better informed pre-employment hiring decisions. The article additionally provides Judgment Risk Indicator Matrix which illustrates a person’s overall assessment results when their Judgment Bias and Risk Appetite scores are shown together. The present paper also provides valuable answers to some most frequently asked questions.

Author Profile:

Tyler D. Nunnally is the Founder & CEO of Upside Risk Corporation, a behavioral risk management consultancy that helps organizations to maximize profit while mitigating risks inherent in human judgment. He currently serves on the Board of Directors of the Technology Association of Georgia (TAG) International Business society.

 

The National Aeronautics and Space Administration Authorization Act of 2010 is a bill that supports the overall growth of science, aeronautics, and space technology. It defines long-term goals for the expansion of the human space flight to a permanent human presence beyond low-Earth orbit. The act specifies funding for an assortment of activities that turn NASA’s focus towards Earth and away from space, including scientific research and aeronautics research and development.

Good Agricultural Practices (GAP) are a collection of principles applied to on-farm production and post-production processes, leading to safe and healthy food and non-food agricultural products, taking into account economical, social and environmental sustainability.

Unemployment insurance tax liabilities have skyrocketed. As a result of the recession, employer-paid UI taxes in 2010 and for the next few years will be significantly higher than in previous years – for some employers tax liabilities have increased by more than 300%. No longer a “nuisance tax,” higher UI taxes are having a negative effect on labor costs, cash flow, and profitability. Higher UI taxes are altering hiring and retention decisions and affecting other talent management decisions. Higher UI taxes are increasing employers’ interest in effective UI cost control techniques. One technique to measure and allocate an organization’s UI taxes liabilities more effectively is internalized experience rating (IER).

These charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

Chart 1: Is an Activity,  Research Involving Human Subjects?

Chart 2: Is the Human Subjects Research Eligible for Exemption?

Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?

Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?

Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?

Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?

Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?

Chart 8: May the IRB Review Be Done by Expedited Procedures?

Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?

Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?

Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?

The guidance contained within this document is intended to apply to medical devices generally and combination products regulated as medical devices. It is not intended to cover in vitro diagnostic medical devices. Additionally, this document was drafted primarily to address the use of Clinical Investigations to support a marketing authorization application. Some aspects of this document may apply to studies conducted following commercial release of a device. Future GHTF documents will specifically address post-market clinical follow-up studies.

This document provides guidance on

• when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles (see GHTF/SG1/N041 – “Essential Principles of Safety and Performance of Medical Devices”); and
• the general principles of clinical investigation involving medical devices

Sections

• General Principles When Considering the Need for a Clinical Investigation
• General Principles of Clinical Investigation Design
• Ethical Considerations for Clinical Investigations

This document provides guidance in relation to:

1. the circumstances where a post-market clinical follow-up study is indicated;
2. the general principles of post-market clinical follow-up studies involving medical devices; and
3. the use of study information, including, for example, to provide information to update labelling.

This document does not apply to in vitro diagnostic devices.

It explains -

• The Circumstances Where A Post-Market Clinical Follow-Up Study Is Indicated
• The Elements Of A Post-Market Clinical Follow-Up Study
• The Use Of Study Information

This document is intended to provide guidance on the content of the STED to be assembled and submitted to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles of Safety and Performance.

The availability of such Summary Technical Documentation (STED) should help eliminate differences in documentation requirements between jurisdictions, thus decreasing the cost of gaining regulatory compliance and allowing patients earlier access to new technologies and treatments.

Major Sections of this document

6.0 Device Description and Product Specification, Including Variants and Accessories
6.1 Device Description
6.2 Product Specification
6.3 Reference to similar and previous generations of the device
7.0 Labelling
8.0 Design and Manufacturing Information
    8.1 Device Design
    8.2 Manufacturing Processes
    8.3 Design and Manufacturing Sites
9.0 Essential Principles (EP) Checklist
10.0 Risk Analysis and Control Summary
11.0 Product Verification and Validation
    11.1 General
    11.2 Biocompatibility
    11.3 Medicinal Substances
    11.4 Biological Safety
    11.5 Sterilisation
    11.6 Software Verification and Validation
    11.7 Animal Studies
    11.8 Clinical Evidence
12.0 Format of the STED
13.0 Declaration of Conformity