The Most Important Compliance Best Practices You Need to Know

Marion Nestle, author of Food Politics: How the Food Industry Influences Nutrition and Health,  writes about how the horsemeat scandal in Europe is really a case study in food politics and the politics of cultural identity.

Republished from www.foodpolitics.com with kind permission of the author.

In this article, Dr Uday Shetty, founder and Executive Director of Drug Regulations, a non-profit organization, discusses the recently issued Indian guidelines for Certifications of API exports to the EU and asks whether these will satisfy the EU's stringent requirements.

Canada is one of the few countries worldwide that has introduced and successfully implemented a regulatory framework for governing the sale and importation of natural health products (NHPs) to consumers. While the initial phase-in was met with disappointing review times and industry confusion over application requirements, the approval process has now become extremely efficient, with some types of NHP applications being approved in as little as 60 days. Sponsors wishing to receive product licences for their NHPs need simply to submit complete applications in proper format, and respond to any information requests within the given deadlines, in order to successfully register their products for sale in Canada.

Yesterday the EU announced its plan to limit bonuses for bankers – the union said that bankers’ annual bonuses should not exceed their annual salaries. The limited bonus plan is a further requirement for banks to follow in order to comply with Basel III and aims at curbing the kinds of risks that bankers have taken in the past to further profit (and led to the recent financial crisis).

The recent settlement of the whistleblower case against Pilgrim's Pride Corp has brought to the fore the OSHA's regulations that protect employees who highlight unsafe practices by employers. This article is a Q&A explainer that clarifies the main points raised by the case.

On May 3, 2012, the FDA released new guidance on ‘Sterility Testing of Biological Products’ after revising the existing requirements for licensed biological products. The new rule on sterility eliminated specific requirements for most products and aims to establish a system in which manufacturers can adopt product-specific and appropriate testing procedures.

This article discusses the potential implications and requirements of the regulation.

Basel III regulations were agreed upon to prevent the sort of economic crisis that the US and some other developed countries experienced, post 2008. The new rules are to be implemented in phases. The first set of rules is to fall in place by January 2013. The Basel Committee criticized the US, EU and Japanese banks for not coming up to expectations for phasing in Basel III requirements.

In a bid to reduce volatility in the US stock markets, the Securities and Exchange Commission (SEC) has approved two new proposals. These proposals are aimed at modifying trading curbs on individual stocks and the broader US stock markets as a whole.

Cal/Osha issued 36 citations to American Reclamation Inc, a Los Angeles-based solid waste company, its recycling subsidiary, South Coast Fibers Inc, and their staffing company, Steno Employment Services Inc. The citations led to a penalty of USD 38,895. The citations were a consequence of complaints lodged by workers on the prevailing unsafe working conditions.

Two professors and a doctoral student undertook a 5-year-long study on the effectiveness of inspections conducted by the California Division of Occupational Safety and Health (Cal/OSHA). This article discusses the main highlights of the study outcome.

GlaxoSmithKline, the British drug maker agreed to pay $3 Billion in fines for promoting its best-selling drugs for unapproved uses and failing to report safety data. The company also faces criminal charges and civic penalties for improper marketing of a half-dozen other drugs and for violating the government's Medicaid program. The fraud settlement includes $1bn in criminal fines and $2bn in civil fines.

This article explains 11 important questions arising from the fraud settlement by GSK.

The Dodd Frank Act, enacted in June 2010 was a result of the 2008 recession. To prevent the recurrence of the financial crisis the Act empowered the US government to regulate the financial sector. This has far-reaching consequences both domestically and internationally. This article discusses the international implications of the Act.

Under Title I of the Dodd Frank Act, two agencies were created to look after the financial health of the US markets – the Financial Stability Oversight Council (FSOC) and the Office of Financial Research. This article discusses why the FSOC was created and the recent lawsuit challenging its constitutionality.

The Orderly Liquidation Authority (OLA) was created under Title II of the Dodd-Frank Act that was enacted in June, 2010. The OLA’s purpose is to prevent those large institutions that are categorized as Systemically Important Financial Institutions (SIFI) from failing.

This article discusses how the OLA came to be and how it modifies the FDIC's current role in the liquidation process.

In the last few weeks, the banking world has been rocked by revelations that derivatives traders at Barclays were rigging the LIBOR rates. This Q&A explainer demystifies some of the core issues behind this event.

Annual Product Review (APR) - Product Quality Review (PQR) reports are the first documents reviewed by health authorities while inspecting a manufacturing facility. The importance of this report is such that even a small error in reported data may have severe impact on product quality and patient safety. Considering its criticality and importance, organizations must try to eliminate errors through process standardization and automation.

This White Paper by Aman Gupta explains six steps that can lead to successful execution of APR-PQR process automation, helping eliminate regulatory reporting errors.

About the Author:

Aman Gupta is an experienced business process consultant. He has worked in several industries including Pharma to help clients in streamlining their processes for productivity gains. He is a CPIM & CSCP (Certified in Production and Inventory Management & Certified Supply Chain Professional), having good command on process areas like demand management, regulatory compliance, online campaign management, supply chain and software package implementation. He can be reached at [email protected].

OSHA does not have specific standards for illnesses and injuries caused to employees by excessive heat. But it has put in place some guidelines that direct employers to prevent the occurrence of heat-related illnesses. This article discusses these guidelines and best practices to be followed.

The Committee on Payment and Settlement Systems (CPSS) and the International Organization of Securities Commissions (IOSCO) have set some new standards for Financial Market Infrastructure (FMI). FMI includes the clearing and settlement systems as well as the recording of financial transactions. It includes the systemically important payment systems, depositories, securities settlement systems and trade repositories.

OSHA recently issued a Call to Action for New Jersey construction companies to ensure the safety of workers at their workplaces. For the same reason, it also monitors the extent to which companies comply with its instructions.

In May 2012, the Chief Executive Officer (CEO) of J P Morgan Chase, Jamie Dixon, announced that the bank had suffered losses to the tune of USD 2 billion because of mistakes made while trading in derivatives. This article discusses the background to this event and the risk controls that could have prevented it.