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 Fleming 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 Fleming 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 Fleming 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 Fleming 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 Fleming on March 22, 2017 at 6:04am — 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 Fleming on March 16, 2017 at 6:00am — 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 Fleming on March 15, 2017 at 6:18am — 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 Fleming 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
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 Fleming on March 10, 2017 at 5:39am — 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 Fleming on March 8, 2017 at 5:12am — No Comments
Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.
The company’s financial statement is intended to provide insights into the…
Added by Adam Fleming on March 3, 2017 at 5:34am — No Comments