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Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?…
Posted by Adam Fleaming on March 24, 2017 at 6:31am
Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.
SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that…
Posted by Adam Fleaming on March 22, 2017 at 6:04am
Wage and Hour calculations are sometimes tricky, but that is no excuse for making mistakes. Wage and Hour mistakes can be extremely expensive for organizations. In 2015, the US Department of Labor (DoL) collected close to a quarter of a billion dollars in back wages for nearly a quarter of a million employees whose pay did not comply with the requirements of the Fair Labor Standards Act (FLSA). Just a misclassification of independent contractors resulted in a seven-figure settlement…Continue
Posted by kate smith on March 17, 2017 at 7:00am
Posted by kate smith on March 16, 2017 at 7:08am
Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…
Posted by Adam Fleaming on March 16, 2017 at 6:00am
Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.
Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.
Lyophilization is considered complex
Parenteral products such as anti-infective drugs,…
Posted by Adam Fleaming on March 15, 2017 at 6:18am
HR metrics are often overlooked or underrated in many organizations. This is a mistake, because HR metrics are very important in assessing the efficiency of the HR policies, programs and endeavors. At the heart of the idea of HR metrics is that whatever is taken up for assessment or implementation has to be measurable. As in any other area of management, HR too has to go by the idiom that what cannot be measured cannot be managed.
The ability for being quantified or measured is…Continue
Posted by kate smith on March 14, 2017 at 7:46am
Strategic planning, as the term indicates, is the act of planning the organization’s strategy. Strategic planning is planning for the organization’s long run. Taking the steps required towards taking the organization to its strategic objectives is strategic execution. While strategic planning is the visualization part, strategic execution is the implementation aspect of this vision.
Strategic planning and execution are about taking steps to visualize the organization’s goals and…
Posted by kate smith on March 13, 2017 at 6:29am
A financial organization, or an organization involved in any business for that matter, faces the prospect of receiving duplicate, fraudulent or late payments. These are the typical payment issues an organization is likely to face at some point of time in its business.
Payment issues are something almost no organization is likely to be free from. Duplicate invoice payments, just one of the payment issues an organization is likely to face, account for losses of…
Posted by Adam Fleaming on March 13, 2017 at 6:02am