Compliance

In manufacturing, design issues are expected to some degree, but when it's medical devices being produced as opposed to televisions, for instance, the stakes are much higher when something goes wrong. Naturally, the FDA keeps a close eye on medical device manufacturers, but these organizations can beat them to the punch with a strong CAPA system in place.

Compliance alone isn't enough, says Michael Volkov. Compliance alone is the bare minimum; fostering an ethical culture takes your compliance program to the next level, requiring little besides commitment. And there's the payoff, of course... employees want to work for companies that operate with integrity, and clients want to do business with ethical organizations.

It's not enough to pay your employees what you owe them. You've got to do it on time, or you may be in violation of the Fair Labor Standards Act. Consequences include owing liquidated damages to employees, interest on any overdue amounts and even penalties violations. And be warned, employers: the federal government isn't the only entity with jurisdiction in...

The costs can really add up when internal investigations get underway, but cutting corners is generally a bad idea. Particularly during the interview process. If you're serious about uncovering the truth, the important interviews should be handled by experienced attorneys, not by counsel a bit greener around the edges who will be less likely to pick up on hints of...

Political and corporate corruption has long galvanized the general public, but over the past several years, some of the ire that was once focused on organized institutions has begun to be directed at individuals. This is what Alison Taylor refers to as Corruption 2.0, and this trend toward anti-corruption measures at the individual level is worth watching.

Though it won't take effect until early in 2017, the time is now for audit committees to start adopting the new accounting regulations. Let's not think that audit committees need to go at implementation alone, however. Warren Stippich advises a cross-functional approach involving players throughout the organization. Here's what you need to know...

The FCPA is one of many tools the DOJ and the SEC put to use in facilitating national security in the U.S. And while they are some of the largest players in protecting the nation's interests, compliance professionals working for global corporations also play a critical role in identifying vulnerabilities and doing serious due diligence to minimize risks.

Those seeking to abuse the system will find a way to do it, so it's imperative that companies implement strong internal controls and then continually strive to strengthen them further. Make no mistake, detecting and preventing FCPA violations takes discipline, but initiatives and activities undertaken with discipline generally pay off, don't they?

Commerce is forever becoming more global in nature, and as a result, maintaining compliance with the federal government's regulations is becoming increasingly challenging. For insurers, the issue is especially complex, as they've got to ensure that not only policyholders, but also potential recipients and third-party claimants aren't barred by the OFAC or residing on its SDN list.

A recent ruling has weakened Hong Kong's anti-corruption and anti-bribery laws, limiting its enforcement power to its borders. The FCPA, UK Bribery Act, and anti-corruption laws of most other Asia-Pac countries stand in contrast to this position, holding perpetrators responsible for corruption wherever they're located.

According to a recent Ernst and Young survey, 67 percent of professionals questioned believe improving the GRC system within their companies should be high priority. There are three key areas to focus on if your firm's governance, risk management and compliance functions need bolstering. Jim Nortz, of Ethics Advisory Services, breaks them down.

With ever-changing legislation and ever-increasing regulatory scrutiny, the role of the CCO is continually evolving. Corporate compliance officers served once upon a time as compliance cops, but the scope of the role has grown over the last several years so that now CCOs must be champions within their organizations of a culture of compliance and ethics and more...