In my opinion, this issue can be addressed by facilitating better communications. Usually, in many organizations the communication is carried out by the medium of pay stub, but this leaves the majority of workers without any access to this effective…   Read more»

In my opinion, both engineers and managers make great supervisors. And engineers especially have those qualities which a managerial position demands as they are analytical, good at managing risk, innovative and very good with figures. So after working in the…   Read more»

A Six Sigma affirmation is an accreditation course that is very well known these days and many people are going for it. It seems that it has lot of weightage in anyone’s resume as it demonstrates one’s capacity and readiness…   Read more»

A PM should avoid nagging his team mates for meaningless questions about project mechanics at all the cost because that leads to loss of faith in the PM. He/She should focus on building a healthy relation within the team and…   Read more»

Any Change or modification to the clinical protocol may be reported in a 5-day notice and they can be implemented if they do not affect: a)validity of data or information resulting from the protocol b)scientific soundness of the investigation plan…   Read more»

Many times the clinical trials conducted by the CRO are done with the intention of gaining maximum profit out of the business without any concern for the safety and efficacy of the patients. In my opinion, the outsourcing policy only…   Read more»

It is difficult to exactly pinpoint the required rate of return due to the various estimates and preferences that differ from one decision maker to another.The various factors that determine the rate of return are the risk return preferences, inflation…   Read more»

Fault Tree Analysis(FTA); which is used to give a graphical representation of the reliability of a system in order to predict the performance of its elements and identify any key poor performers that need further designing.And maintains the overall life…   Read more»

In my opinion, if it is a small organization looking for outsourcing, then it should go for smaller vendors to cut down on the cost and to maintain flexibility rather than going for larger players as they may not provide…   Read more»

Photodynamic therapy with PHOTOFRIN is an example of combination device that comprises of two stages. In the first stage, an intravenous injection of PHOTOFRIN is given to the patient. It gets cleared from most of the tissues over 40-72 hours,…   Read more»

In my opinion, the project review meetings are vital for delivering the status of the project to executive management and other stakeholders, it provides them with the updates and the major milestones of the project, while addressing any emerging issue…   Read more»

In my opinion, completing the product life cycle is not that easy in real life.A bunch of people who are experts in their fields and are working together to complete a project, will have to overcome many minor issues with…   Read more»

Once the problem is identified by someone and it requires a change.The scope of the issue and its possible impact are estimated before generating an engineering change request (ECR) to examine the feasibility of the change that might include identification…   Read more»

I do not have any personal experience with FDA audits. But i feel its always wise to adhere to the Good Clinical Practices(GCP) to stay on the safer side. Sticking to the proper Standard Operating Procedures(SOP) to maintain the consistency,…   Read more»

Every project requires the Monitoring and Controlling Process to review the progress and make changes in it to eliminate chances of future setbacks and to increase the workflow. And it comprises of set of skills and knowledge to implement the…   Read more»

I agree with Robert, that the suppliers must be contacted in the Project Planning Phase as this is the phase where the PM has to make an educated guess of the staff, resources and equipment needed to complete the project….   Read more»

I would like to add to the above discussion that in any quality assurance, the corrective plan is vital to address any type of gaps in the quality controls or procedures. And in order to do that, the person responsible…   Read more»

I would say this course is a must for anyone and everyone looking for career advancement in any field. It really helped me by giving an insight into the life of a PM and helped me understand better the roles…   Read more»

Any company seeking global presence, has to consider several key factors to handle an international project successfully such as: 1. Legal Systems 2. Quality Standards 4. Language Barriers 5. Time Zone Changes 6. Economic Conditions 7. Cultural differences. If these…   Read more»

In any project, the milestones are the important landmarks to assess the project.The project manager uses milestones to gauge if the project is on the right track, whether it is ending the project phase or completing the deliverables. In order…   Read more»