Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.
Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory…
Added by Adam Fleaming on March 30, 2017 at 6:42am — No Comments
Whilst everyone wants to do ‘safety differently’, it is not likely that reform will come within. The paradigm of safety with its primary focus on measurement actually mitigates any hope of innovation, creativity or critical thinking. If…Continue
Added by David Collins on March 29, 2017 at 11:16pm — No Comments
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.
The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…
Added by Adam Fleaming on March 28, 2017 at 9:06am — No Comments
Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.…
Added by Adam Fleaming on March 27, 2017 at 8:31am — No Comments
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?…
Added by Adam Fleaming on March 24, 2017 at 6:31am — No Comments
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…
Added by Adam Fleaming on March 22, 2017 at 6:04am — No Comments
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
Added by kate smith on March 17, 2017 at 7:00am — No Comments
Added by kate smith on March 16, 2017 at 7:08am — No Comments
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.…
Added by Adam Fleaming on March 16, 2017 at 6:00am — No Comments
Added by kate smith on March 15, 2017 at 7:11am — No Comments
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,…
Added by Adam Fleaming on March 15, 2017 at 6:18am — No Comments
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
Added by kate smith on March 14, 2017 at 7:46am — No Comments
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…
Added by kate smith on March 13, 2017 at 6:29am — No Comments
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…
Added by Adam Fleaming on March 13, 2017 at 6:02am — No Comments
When it comes to deciding between using solvent-based or water-based paints for a given job, we all know the basic pros and cons: water-based paints will typically smell less…Continue
Added by Alex on March 13, 2017 at 5:30am — No Comments
The mentor-mentee relationship is a very important one in an organization. In a large way, the mentor-mentee relationship defines and determines the destiny of the organization. Although there are no rules or laws for the mentor-mentee relationship; an organization in which this relationship…Continue
Added by kate smith on March 10, 2017 at 7:44am — No Comments
That the inputted data should be “normally distributed” is a requirement of the calculations used in many statistical tests and methods. Typically, the methods used for Student’s t-Tests, ANOVA tables, F-tests, Normal Tolerance limits, and Process Capability Indices include such calculations.
A core criterion for ensuring the correct results is the one that the raw data used in such calculations be “normally distributed”. It is in view of this fact that the…
Added by Adam Fleaming on March 10, 2017 at 5:39am — No Comments
Organizations that deal with labor and employment laws relating to social networking are caught in a “damned if you do, damned if you don’t” bind. As many laws as one can imagine are applicable. Think of any of these:
o The Financial Industry Regulatory Authority (FINRA)
o The Federal Trade Commission
o The Genetic Information Nondiscrimination Act
o The National Labor Relations Act
o The Health Insurance and Portability Act.
The provisions of any of these laws…
Added by kate smith on March 9, 2017 at 4:32am — No Comments
Forms 940, 941 and the W-2 are important filings that need to be done with the Internal Revenue Service (IRS). Any lapse on the part of the organization filing these payroll forms can lead to confusion, and on top of it, to IRS notices. One of the factors that add to the confusion about these IRS forms is that they keep changing, at least to some degree, from year to year.
A basic understanding of the filing of IRS forms 940, 941 and the W-2
IRS Form 940
IRS Form 940 is for…
Added by kate smith on March 8, 2017 at 5:36am — No Comments
Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.
Added by Adam Fleaming on March 8, 2017 at 5:12am — No Comments