This document summarizes four Supreme Court cases related to education, criminal procedure, corporate law, and insurance regulation. Brown v Board of Education declared segregation in public schools unconstitutional. Miranda v Arizona established that suspects must be informed of their rights and inadmissible confessions cannot be used as evidence. Paul v Virginia ruled that corporations are not citizens under the Privileges and Immunities Clause and that insurance is not interstate commerce. South-Eastern Underwriters overturned Paul v Virginia, finding that insurance transactions are subject to federal regulation under the Commerce Clause.
A handful of new information came out at the FDA pharma social media hearings, but quite a bit was missing as well. Here's my brief overview of what I learned and what I thought was missing
FDA Form 483 (Inspectional Observations) - Top Violations 2013Marc Sanchez
FDA Attorney Marc Sanchez discusses the Top FDA Form 483 (Inspectional Observations) from fiscal year 2013. The top observations provide a foundation for preparing for a pre-inspection, for-cause inspection, or routine surveillance inspection.
3 top ten fda warning letter findings by theShirley Roach
The document outlines the top ten most common Good Manufacturing Practice (GMP) findings by the FDA in fiscal year 2003 based on Form 483 observations. The most frequent finding was a failure to follow and/or document written production and process control procedures, which was referenced on 317 Form 483s. Other top findings included responsibilities of the quality control unit, written procedures for production and process controls, testing and release for distribution, and validation. The document also provides examples of common GMP violations found during inspections, such as dirty facilities, unqualified equipment, and lack of corrective and preventative action procedures.
This document summarizes four Supreme Court cases related to education, criminal procedure, corporate law, and insurance regulation. Brown v Board of Education declared segregation in public schools unconstitutional. Miranda v Arizona established that suspects must be informed of their rights and inadmissible confessions cannot be used as evidence. Paul v Virginia ruled that corporations are not citizens under the Privileges and Immunities Clause and that insurance is not interstate commerce. South-Eastern Underwriters overturned Paul v Virginia, finding that insurance transactions are subject to federal regulation under the Commerce Clause.
A handful of new information came out at the FDA pharma social media hearings, but quite a bit was missing as well. Here's my brief overview of what I learned and what I thought was missing
FDA Form 483 (Inspectional Observations) - Top Violations 2013Marc Sanchez
FDA Attorney Marc Sanchez discusses the Top FDA Form 483 (Inspectional Observations) from fiscal year 2013. The top observations provide a foundation for preparing for a pre-inspection, for-cause inspection, or routine surveillance inspection.
3 top ten fda warning letter findings by theShirley Roach
The document outlines the top ten most common Good Manufacturing Practice (GMP) findings by the FDA in fiscal year 2003 based on Form 483 observations. The most frequent finding was a failure to follow and/or document written production and process control procedures, which was referenced on 317 Form 483s. Other top findings included responsibilities of the quality control unit, written procedures for production and process controls, testing and release for distribution, and validation. The document also provides examples of common GMP violations found during inspections, such as dirty facilities, unqualified equipment, and lack of corrective and preventative action procedures.