Compliance Resources to Help you Stay Current

In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, discusses the best ways to conduct cleaning test method validation. Marcelle discusses the various steps involved and different regulatory recommendations for this essential process in the manufacture of drug products.

This article establishes a rationale to justify the level and extension of Environmental Monitoring to be applied at non-sterile pharma facilities based on the risk compound by  factors such as location and product susceptibility to microbial contamination.

The author, Marcelle Cortezia, has ten years of experience with major pharmaceutical companies and is at present a Quality Manager with Dentsply.

The California Online Privacy Protection Act of 2003 or OPPA, which became effective on July 1, 2004, was the first state law that required owners of commercial websites or online services to post a privacy policy.

This article discusses the applicability of the Act and summary of its requirements.

The Energy Independence and Security Act (EISA) of 2007 was signed into law by President Bush and aimed towards moving the US towards greater energy independence and security.

This article discusses the background to the act and summary of its requirements.

On September 2, the Federal Housing Finance Agency (FHFA) filed lawsuits against 17 financial institutions for allegedly misrepresenting mortgages in securities filings.

This article details the reasons for the lawsuits, response to the FHFA’s actions and likely impact.

The Federal Travel Regulation or FTR contains the requirements and policies that cover travel by federal employees and others authorized to travel at government expense.

This article gives an overview of the FTR, its applicability and summary of requirements.

The manufacture of pharmaceuticals requires strict adherence to standards and regulations. ISO 14644-1 details the requirements that pharma manufacturers have to follow with respect to clean room environments.

In this article, Yara Almouti, an expert on cGMP in the pharma industry, explains these requirements.

Medical devices need to be reliable and safe - and reliability engineering is key to ensuring this. But how do you effectively leverage reliability engineering to create successful devices?

Dev Raheja, a recognized expert on medical devices, explains how and why reliability engineering matters during the production of medical devices.

US President Obama recently announced more sanctions against the current Syrian regime led by President Bashar el Assad. Syria has been rocked by anti-government protests and violence for much of 2011.

These new sanctions have been taken pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (IEEPA) and Syria Accountability and Lebanese Sovereignty Restoration Act of 2003 (Public Law 108-175) (SAA).

This article discusses the details of these additional sanctions and how American businesses are expected to comply.
 

The ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories - is an international standard that applies to laboratories. It specifies the general requirements for the competence required in a laboratory to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

This article describes the applicability and use of this standard and summarizes its requirements.

President Barack Obama has announced that federal regulatory agencies have reviewed and will soon start a rollback of outdated and cumbersome regulations. The scrapping of regulations is expected to “eliminate millions of hours in annual paperwork burdens for large and small businesses and save more than $1 billion in annual regulatory costs”.

This article details the background to this regulatory reform and its expected impact on US businesses.

The Securities and Exchange Commission was accused of destroying documents pertaining to inquiries at an early stage, in violation of federal record management policy.

This article gives the background to the issue and details of the federal regulation the SEC is accused of violating.

The SEC’s new whistleblower program came into effect on August 12, 2011. As part of this program, the agency also unveiled a website to help people report violations of federal securities laws and apply for a financial award.

This article discusses the background, highlights of the program, the final rule and response from industry.

Google has agreed to pay $500 million dollars as a settlement in a Department of Justice inquiry into whether the search engine’s advertisements for online Canadian pharmacies led to illegal imports of prescription drugs.

This article gives details of the allegations against Google and the regulatory violations that led to the inquiry.

An FAA regulation aimed at preventing pilot fatigue, inspired by a 2009 plane crash near Buffalo, New York, and due to be issued on August 1 has been delayed. The agency did not give a reason for the delay but the proposed rule has been criticized by cargo and charter carriers as well as the Pentagon.

This article gives the background and provisions of the proposed rule and response to it from various stakeholders.

The Environmental Protection Agency (EPA) has pulled DuPont’s herbicide Imprelis, blamed for killing trees in numerous states, from the market. The EPA is investigating if the company violated the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

This article describes the reasons for the ban, responses to it and the litigation resulting from the use of the herbicide.

President Barack Obama announced new fuel efficiency program for heavy duty trucks including school buses and garbage trucks. The regulations will require fuel efficiency improvements of around 23 percent by Model Year (MY) 2018.

This article discusses the background to the new standards, the expected savings and costs and summary of provisions.

On July 29, 2011, President Obama announced that the US government and thirteen major automakers had agreed on a new standard that would increase fuel economy of cars and light duty trucks to 54.5 miles per gallon for cars and light duty trucks by 2025. This article describes the background to these standards, estimated savings and proposed provisions in the new standard.

The FDA has for the first time issued a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily. The agency is presently accepting comments on these draft guidelines.

This article provides a summary of the guidance document’s recommendations.

The Institute of Medicine has released a report that has found the FDA’s existing rules for the 510(k) clearance lacks the legal basis to be a reliable premarket screen of the safety and effectiveness.

The report has been criticized by the medical device industry while patient rights groups have welcomed its findings.