The Most Important Compliance Best Practices You Need to Know

The Home Mortgage Disclosure Act or HMDA applies to financial institutions, like banks, savings associations, credit unions, and other mortgage-lending institutions. In 2011, over 16.3 million loan records for the calendar year 2010 were reported by 7,923 institutions.

What are the best practices to be followed in order to comply with the HMDA? Read this article to find out.

Under US federal regulations, financial privacy is guaranteed to customers of financial institutions. But what are the best practices that banks can follow in order to protect the sensitive customer data and ensure compliance with regulatory requirements?

Read this article to find out.

Business continuity is a key operational and risk management consideration for financial institutions such as banks. But what are the strategies that banks should follow in order to ensure that there is no unnecessary disruption to their daily operations?

Read this article to find out how banks can implement business continuity strategies and the best practices they can follow.

In this extract from his book, IFRS Simplified, Mike Morley, a Certified Public Accountant, gives a brief overview of the International Financial Reporting Standards (IFRS) requirements for financial instruments.

The largest corporate bankruptcy in US history (Enron) shook the very foundation upon which the securities exchange system was founded. The report card that investors and lenders used to make their decisions, the audited financial statement, could no longer be trusted. Investors and lenders lost confidence in public company senior management to tell them the truth.

In this article, Mike Morley, a Certified Public Accountant and author of several books including “IFRS Simplified" and "Sarbanes-Oxley Simplified", discusses what led to the collapse of investor confidence in Enron.

Prevention is better than the cure when it comes to fraud as organizations around the world lose around 5% of their annual revenues to corporate malpractices. So how can a financial services organization create an effective anti-fraud policy to prevent such losses? What are the factors to be taken into consideration when drafting such a policy?

This article gives the best practices to follow when drafting an anti-fraud policy for financial institutions.

According to an estimate, the amount of money laundered annually ranges from USD 500 billion to about USD 3 trillion. How can organizations estimate the risk that money laundering poses to their operations and comply with anti-money laundering regulations?

This article discusses the best practices to follow in preventing money laundering.

According to a Certified Fraud Examiners Survey, organizations lose an estimated 5% of their annual revenue or about USD 2.9 trillion of the gross world product, because of fraud. The average time taken to detect a fraud is about 18 months.

This article discusses the best practices to be followed by financial institutions when creating a fraud response plan.

PCAOB Audit Standard No. 5 contains new standards and guidelines for independent auditors to affirm and report on the effectiveness of an organization’s internal control over financial reporting, in terms of Section 404(b) of Sarbanes-Oxley Act. It effectively replaces PCAOB Standard No.2. The new standard makes Section 404(b) more effective by promoting risk-based audits depending on the size and complexity of the organization.

This article discusses how to comply with this standard and the best practices to be followed.

Medical device recalls happen frequently due to faulty device design or usability. How can medical device manufacturers prevent medical device recalls? What are the best practices to be followed?

In this article, Dev Raheja, a recognized expert on medical devices, discusses the various kinds of recalls, how the FDA oversees these and how to prevent them.

IEC 80001 is an international standard for managing risks in IT networks using medical devices. Its aim is address issues of safety, effectiveness, data, and system security in the network. The standard defines the process and also defines responsibilities for each of the stakeholders involved. It recognizes that risk management should be applied throughout the lifecycle of the networks. 

This article discusses the best practices for medical device manufacturers to comply with this standard.

The Compensation Committee Revised Rules of 2006 require that all compensation earned by a company’s senior executives (chief executive officer, chief financial officer, and three most-highly-compensated officers, earning above USD 100,000) in the last fiscal year be disclosed.

This articles discusses the best practices to be followed in order to comply with these regulations.

The Food and Drug Administration (FDA) receives spontaneous adverse event reports from health care professionals and consumers. A manufacturer, upon receiving an adverse event report from a patient or health care professional, has to send a report to FDA.  The U.S. Department of Health and Human Services (HHS) Food and Drug Administration Center for Biologics Evaluation and Research (CBER) has mandated reporting of adverse events and has issued guidance towards this end.

This article describes the best practices to be followed in the reporting of adverse events.

Under OSHA regulations, employers have to recognize and catalog workplace hazards so that any workplace accidents and dangers to employee health and safety can be prevented.

This article describes the best practices to be followed in recognizing and cataloguing workplace hazards in compliance with OSHA's regulatory requirements.

The Food and Drug Administration (FDA) requires manufacturers of medical devices to create and maintain a device master record (DMR). Section 820.3(j) of the Federal Code defines device master record. DMR is a set of documents containing procedures and specifications for a finished medical device. 

This article gives the best practices for maintaining DMR to comply with medical device regulations.

Off-label use is the practice of prescribing drugs for an unapproved condition or in an unapproved age group, unapproved dose or unapproved form of administration.  Unlike the drugs approved by the Food and Drug Administration (FDA), off-label drugs do not undergo mandatory clinical trials to determine the dosages, efficacy, or side effects.

This article discusses the best practices to be followed in the off-label marketing of drugs.

A vaccine is a biological preparation that provides immunity against a particular disease. It is usually made of dead or weakened organisms which cause the particular disease. Biosafety means the safe handling of infectious biological materials which can cause diseases. Biosafety level refers to safety tiers prescribed by the Center for Disease Control (CDC), a United States Federal Agency, for laboratories which work with infectious materials. 

This article discusses how to comply with biosafety risk assessment requirements during vaccine production.

Abbreviated New Drug Application (ANDA) is an application for approval of a generic drug. This application is submitted to the FDA Center for Drug Evaluation and Research (CDER) for review and approval. Using bioequivalence for generic drug approval was established by the Waxman-Hatch Act. 

This article describes the requirements for bioequivalence data submission for ANDA to the FDA.

An ethics committee protects the rights and interests of the people in a clinical trial. The ethics committee is usually comprised of individuals from diverse backgrounds like local health care professionals, counselors, social workers, lawyers, and community representatives. Practices of ethics committees vary enormously across Europe, Australia, Canada, and USA.

This article gives an overview of best practices that ethics committees can follow in order to execute their roles and responsibilities in an effective and compliant manner.

The informed consent is process is a cornerstone in the ethical conduct of clinical trials and research on human subjects. Regulatory requirements for this important process varies from country to country.

This article gives an overview of best practices for getting informed consent from human subjects in various international jurisdictions.