The Most Important Compliance Best Practices You Need to Know

The SEC conflict mineral rule that came into force on January 1, 2013 has led to widespread confusion over applicability and what the law requires. Companies are also unsure of what processes to adopt in order to comply with the rule’s requirements and what they are expected to report to the regulator.Ignoring the rule can come at a high cost – businesses can be sued for fraud and face regulatory action.If a company is found to have used a mineral from a supplier that is supporting human rights abuses,the damage to its reputation can be irreparable. This white paper provides an overview of the conflict minerals issue, explains the SEC rule and provides five best practices that can be adopted in order to ensure regulatory compliance.

The FDA has been cracking down on non-compliance in vitro diagnostic products or IVDs recently. Manufacturers have not been adhering to the strict regulations governing the use of these products, and have been falling short when it comes to the compliant labeling of these devices. This White Paper puts together five best practices that can help IVD manufacturers improve their compliance with labeling and avoid FDA citations, Warning Letters, product recalls and worse.

The FDA has strengthened its scrutiny of animal drug products as public awareness of the issues surrounding their use and adverse events have increased. A number of manufacturers have been warned about marketing products with treatment claims without first obtaining approval from the agency. The approval process for a veterinary drug is as complicated and rigorously analyzed by the FDA as the one for human medicines. This White Paper details what is considered an animal drug, the different types of applications and finally explains five best practices that manufacturers can adopt in order to ensure better compliance with the application process for a new animal drug.

Banks and other financial institutions have benefited massively from modern systems thatfacilitate quick transactions across the world. But these same systems can be abused bycriminals spread across geographies and institutions that turn a blind eye to such suspicioustransactions can pay a heavy price when they are caught by regulators. Thus, organizationsmust ensure that they have strong anti-money laundering programs in place to prevent suchactivity and the cornerstone of a strong program is a robust Suspicious Activity Reporting (SAR)process. This White Paper describes some of the best practice that banks and other financial organizations can adopt in order to build an effective and efficient SAR process.

Recent events have shown that in an increasingly globalized food production environment, food safety has emerged as a vital public issue. Food manufacturers are increasingly under scrutiny both from governments and consumers regarding their production methods, quality practices and commitment to product safety. One of the cornerstones of a strong food safety management system is HACCP. It is a systematic approach to the identification, evaluation, and control of food safety hazards based on seven core principles. The seventh HACCP principle focuses on setting up record keeping and documentation procedures to ensure compliance with food safety regulatory requirements. For the successful implementation of HACCP, appropriate documentation and records must be kept and be readily available. This White Paper describes some of the record keeping best practices that will help food manufacturers ensure compliance with HACCP requirements related to food safety management systems.

The HIPAA Final Omnibus Rule was published on January 25, 2013, by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). The amendments to HIPAA found in the Final Rule are extensive and address complex healthcare regulatory schemes. It broadens the definition of business associates and provides new requirements for business associate agreements. All kinds of covered entities as well as business associates of covered entities need to review their HIPAA policies and procedures in order to comply with changes in these rules. This White Paper provides some of the best practices the covered entities can adopt to ensure that their business associates are in compliance with requirements of the HIPAA Final Omnibus Rule.

In this article, James Bone, a leading expert on GRC, analyzes the recent speech Mary Jo White, Chair of the S.E.C, gave at the the Council of Institutional Investors in Chicago this fall.

James Bone, a leading expert on GRC, explains why risk management programs at most companies are failing, why the organizations are not aware of this phenomenon and how to rectify the situation.

In this paper, Frederick D. Lipman, Partner - Blank Rome LLP and President, Association of Audit Committee Members, Inc., discusses methods of improving the flow of information to audit committees so that they are better able to perform their oversight function.

About the Author:

Frederick D. Lipman is Partner - Blank Rome LLP and President, Association of Audit Committee Members, Inc. Mr. Lipman is an internationally known authority on business law and has authored 14 books, including Whistleblowers, Incentives, Disincentives and Protection Strategies (John Wiley & Sons, Inc. 2012), The Family Business Guide (Palgrave Macmillan 2010), International and U.S. IPO Planning (John Wiley & Sons, Inc. 2009), Valuing Your Business: Strategies to Maximize the Sale Price (John Wiley & Sons, Inc. (2005), Executive Compensation Best Practices (John Wiley & Sons, Inc. 2008), Corporate Governance Best Practices (John Wiley & Sons, Inc. 2006), Audit Committees (The Bureau of National Affairs, Inc. 2008), and International Strategic Alliances:  Joint Ventures Between Asian and U.S. Companies (Daniel Publishing LLC 2012). For more information, please go here: www.blankrome.com/index.cfm

New York City employers beware: The New York City Council has once again acted to expand the nation’s broadest anti-discrimination law — this time to prohibit discrimination against New York City’s unemployed. The law will go into effect on June 11, 2013.

The Dodd-Frank Act requires publicly traded companies to take steps to verify and to publicly report their use of so-called “conflict minerals.” The SEC has now passed a final rule implementing the Act's requirements. In this article, Gregory Husisian, an expert on export control issues and trade compliance, explains the various steps companies have to take in order to ensure compliance with the SEC regulations.

About the Author

Gregory Husisian is a partner with Foley & Lardner LLP and has extensive experience in export controls and economic sanctions, the Foreign Corrupt Practices Act (FCPA), corporate risk management and compliance, and issues arising from international trade. Mr. Husisian is a member of the firm’s Government Enforcement, Compliance & White Collar Defense, Securities Enforcement & Litigation, Automotive, Appellate, and International Practices and the Insurance & Reinsurance Industry Team. For more information, please visit: www.foley.com/gregory-husisian/

Serendipity has often provided unanticipated insights into chemistry and toxicology, among other fields.

Developing a new defense strategy [FAEDER, BRUYA, & CLARKE, 2011] for a Proposition 65 [OEHHA, 2012A] case in California, the authors undertook a variety of QA/QC procedures to be assured that their test results regarding exposure to DEHP [TOXNET, 2012A] from the consumer product at issue had precision and validity. One such procedure was to ascertain if the test subjects had measurable DEHP on their hands prior to the test in which they handled the product at issue.
 

In this article, Mithun Raja B. and Raghavendra Rao K., explain the clinical and regulatory requirements governing the process of prescription to OTC switches in USA and India. The article discusses the reasons for these switches, the process itself and what regulatory agencies in both countries require from pharmaceutical manufacturers.

Do you really know who you are doing business with in your supply chain? How much due diligence is enough? Should you update your due diligence on a regular basis? How about on a continuous basis? What ethical considerations come into play in the manufacturing sector, in the supply chain? These questions, and perhaps more, came to me as I was reading about the recent tragedy in Bangladesh involving the collapse of Rana Plaza. At this time, there are 433 confirmed dead and police report that 149 people are still missing in what has become the worst disaster for Bangladesh’s $20 billion-a-year garment industry. The collapsed building was built and owned by Mohammed Sohel Rana, he was not the owner of the factories that operated in Rana Plaza; he was simply the building owner and landlord and, therefore, is legally required to provide a safe structure.

Republished from FCPA Compliance and Ethics Blog with kind permission of the author.

The debate on whether the use of Deferred Prosecution Agreements (DPAs) and Non-Prosecution Agreements (NPAs) has become lively again over the past couple of weeks. Last week, there was a panel hosted by the Corporate Crime Reporter conference at the National Press Club. The panel was moderated by Steven Fagell, a partner at Covington & Burling LLP, and the panelists included Denis McInerney, the Criminal Division’s Deputy Assistant Attorney General, David Uhlmann, the former chief of the Environmental Crimes Section at the Department of Justice (DOJ), and currently a Professor of Law at the University of Michigan, the FCPA Professor, Michael Koehler, Kathleen Harris, a partner at Arnold & Porter LLP in London, and Anthony Barkow, a partner at Jenner & Block in New York.

Republished from FCPA Compliance and Ethics Blog with kind permission of the author.

In the two most recent corporate Foreign Corrupt Practices Act (FCPA) enforcement actions, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC) to communicate not only what they believe constitutes a best practices compliance program but equally importantly what actions a company can engage in which will significantly reduce a company’s overall fine and penalty. These matters involved Parker Drilling Company (Parker Drilling) and the Ralph Lauren Corporation. Parker Drilling received a Deferred Prosecution Agreement (DPA) and Ralph Lauren sustained a Non-Prosecution Agreement (NPA).

Republished from FCPA Compliance and Ethics Blog with kind permission of the author.

In this article, Haroon Atchia, CEO & Technical Director of Quality First International provides a critical examination of the European Commission's update of MEDDEV 2.12/2 entitled Post Market Clinical Follow-Up Studies, a guide for Manufacturers and Notified Bodies, published in January 2012.

In this article, Melvin Dionne, a pharmacist-consultant, provides a high level overview of Canadian regulations governing the licensing and manufacturing of natural health products.

In this article, Dr Uday Shetty, founder and Executive Director of Drug Regulations, a non-profit organization, provides insight into the recent Indian Supreme Court's decision on the Novartis cancer drug Gleevac and explains the reasoning behind the court's ruling on not granting a patent for the product.

Marion Nestle, author of Food Politics: How the Food Industry Influences Nutrition and Health,  writes about the FDA's recently published food safety rules.

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