Shachi

Forum Replies Created

RE: Disconnect in rewarding motivation

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 majorit...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Engineer vs. Manager

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, inno...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Six Sigma Green Belt Certificate

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'...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Let's Be Motivated!!!

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 rela...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Change Requests During Clinical Trials

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...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Discussion Topic: Outsource vs. Insource the clinical trial

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 opi...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Discussion Topic: Costs and managing your investment

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 ...

In forum Project Management Knowledge Areas

8 years ago
RE: Discussion Topic: Risk Analysis methods

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...

In forum Project Management Knowledge Areas

8 years ago
RE: Procurement Management

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 ...

In forum Project Management Knowledge Areas

8 years ago
RE: Combination Product

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...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Design Review Meeting Culture

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...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Ideal PM Processes vs. Real life

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 m...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Engineering change order

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 fea...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Work Logs and FDA Audits

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 Pro...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Monitoring & Controlling Techniques

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 se...

In forum Project Management Process and Medical Device Development

8 years ago
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