Tools and Methodologies to Predict and Improve Product Reliability

Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be […]

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. […]

Assessment-based prediction is an effective tool for hiring the right candidate

Undoubtedly, hiring should rate as being among the most important activities for an organization. This is so because it is through this process that the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up […]

New Way of Exploring Economic Environment

Lineament analysis in geological exploration The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of […]

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons: Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products […]

Understanding supplier management for medical devices

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. […]

Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard. A highly meaningful […]

Getting overtime pay calculation wrong can be damaging for the employer

A thorough grasp of the subtleties of the Fair Labor Standards Act (FLSA) continues to elude many employers, even though this Act has been around for a long time. The frequent changes that keep happening to the many regulations of the FLSA from time to time are one of the major reasons for this. These […]

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. Although these new guidelines appear to remove the need to follow GMPs for […]

The interconnectedness between human resources and project management

Although a superficial look may suggest nothing in common between HR and project management; upon scratching the surface a bit, one discovers a close relationship between the two. Project management and HR are very closely related to each other, if one considers the similarity in the approach to the two disciplines: Project management is rooted […]