Sarah Hamilton

The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management procedures/policies to CFR requirements. The agency e...

As the overall cost of storage and regulatory operations increase, many companies are searching for an integrative, cost-saving option.  With multiple avenues for regulatory and compliance issues, executives and management often find...

Financial organizations experience the burden of regulatory processes required to remain compliant with the ever-changing regulations. Lack of ability to process documents and make quick decisions in a consistent manner across all are...

Unpredictable and a constantly shifting regulatory climate is the new norm, and banks and other financial institutions need to prove strict compliance on all fronts at any time. More and more, regulators are cracking down on these ins...

It's difficult to keep up with regulatory compliance because it changes all the time. Complying with changes in corporate compliance documentation, internal controls, audit requirements, employee training, etc. In addition, compliance...

Can the factors that optimize learning be defined and then can they be part of a metrics evaluation process? What is the role of culture, language and care (intrinsic Vs. extrinsic) with regard to alertness to bad practice and in the ...

Wouldn’t you want to be the person with the solution rather than the person who has to keep reporting the problems? Time is money. Money is time. Sometimes accidents are caused by employer pressure, but other times it can be you, a...

Most Regulatory agencies are clear about what they are looking for during the auditing process, but what they are not clear about is the process or a system as to how you will achieve compliance i.e. What should be the components of a...

When it comes to governance, risk, and compliance, simplicity is not the first thing that comes to mind. Working in regulatory compliance can seem like an over-complicated maze of run-on sentences and unclear requirements at times. Bu...

The Safety and Environmental Management System (SEMS) program was developed for organizations to meet two core objectives i) Accident & Incident Prevention and ii) Prevention of the release of  hazardous substance in the environm...