There is a huge difference in working at bench in industry and working at bench in academic. In industry there is an advantage of working with a supportive team in a good environment and there is always some meaningful projects…   Read more»

Clinical trials help doctors to assess if the new medicine is more effective or safer than old medicines or treatments, and to determine the correct dosage of the medicine. Terrible things do happen as indicated by the incident in France…   Read more»

The clinical trials for new medications take place all over the world, but developing countries often serve as cost effective locations.  The developing country has a lot of people who are more likely to want to be in a trial….   Read more»

A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Real benefit is that the…   Read more»

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.  This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. The purpose of…   Read more»

Internal audits are helpful for small businesses. They can be performed relatively easily without much cost, and the end result is a better understanding of the way your business operates. Companies often hire external auditors in addition to audit themselves…   Read more»

Corrective Action is-based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Corrective and Preventive Actions are integral parts of a continuous improvement program. To correct or…   Read more»

Correction is taken to rectify a known nonconformance; Corrective Action is taken to prevent recurrence of said nonconformance.. Correction will take very little investigation to find and is a quick fix for this one-time problem. However, it does not take…   Read more»

Internal audits are a great opportunity for a company to learn and grom It can evaluate processes and ensure that company is meeting quality standard The goal is to gather information about the effectiveness of the quality system . Internal…   Read more»

Each of the product life cycle has its own characteristics.The introduction stage is most expensive stage in the life span of a product .As products have a limited life span so most of companies invest heavily on new product to…   Read more»

Interpersonal skills and business skills both are important to make a good deal.Interpersonal skills are the way to how someone relate and communicate with other.Without interpersonal skill everyday business would be very difficult .For various reasons interpersonal skills are crucial…   Read more»

Funding problems that arises during an innovation project are one of the biggest obstacle to innovation.Financing of next innovation phases is no longer guaranteed.The objectives of technical feasibility is to confirm that product will perform and to verify that there…   Read more»

When a component of equipment experience a failure,the nature and cause of failure should be investigated and analyzed.Root cause analysis is important to determine the cause of breakdown so that steps can be taken to manage the cause and avoid…   Read more»

Revalidation is required when the equipment is modified,relocated,or otherwise changed in a manner which may effect the process.Any change in the equipment need to be evaluated to determine the potential consequences on validation status.The Revalidation may be required based on…   Read more»

Moving equipment from one place to another,usually requires revalidation .Revalidation is needed to ensure that changes in the process or in process environment do not adversely effect process characteristics and product quality.when equipment is moved to a new location installation…   Read more»

ECO’s make it possible to accurately identify ,address and implement product change while keepin all key stakeholders in the loop and maintaining a historical record of product.The change process starts when someone identify an issue that need to be addressed…   Read more»

Dimensioning the QMS documentation based on organizational needs is essential for a functional QMS.The first set of QMS requires manuals,record ,procedure are required in simplest form.Small organization focus on documentation should be simple and ultimate customer’s satisfaction .They can have…   Read more»

PMS is a collection of processes and activities used to monitor the performance of a medical device.PMS can improve device,provide better services to users and reduce the risk of adverse events before it happen.If manufacturer introducing new technology ,should respond…   Read more»

SOP’s are step by step procedure how to do something that is critical to quality ,safe operations and security.SOP involves procedure and work instructions .The correct level of details required depends on task complexity, level of detail increases with task…   Read more»

DHF contains all the design records from inception to launch and changes over time.DMR is one of the outputs from the DHFas It contains the specification that were developed during design process.Their difference resides in the phase of product life…   Read more»