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andria93 replied to the topic Form 483 in the forum Quality Control and Quality Assurance 6 years, 8 months ago
I do agree with you, but from my experience that even when the SOP is correct and up to the standers, sometimes it is a production issue that by human mistake is not following the BOM list and SOP even though everything is defined very clearly. SO I think it is hard to eliminate any mistakes by locking the SOP or have a preventive action on it.…[Read more]
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andria93 replied to the topic A day in the life working in QA/QC in the forum Quality Control and Quality Assurance 6 years, 8 months ago
I helped the QA department when I was a CO-OP with Panasonic innovation center, and it was mainly focused on QA testing and validation for enterprise kiosks. they were short-handed so I didn’t really get involved in everything. I only supported it part of my time, So I used to understand how the system should work and come up with a validation…[Read more]
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andria93 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
I don’t work directly with process involve working with FDA, But I’ve heard how long it takes for FDA to process. One of the most concern when we work with project required FDA approval for part replacement, the company will try to avoid because of testing and requalification could take months if not a year. But, on the other hand, FDA tries to…[Read more]
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andria93 replied to the topic RECALLS in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
I think it is like other devices that can have a recall for corrective actions, but when we talk about medical devices it is more sensitive as it could cause life-threatening. The human body could have a different reaction to any implementation or even procedures. So Even FDA approve it and companies do research and test. It’s still possible that…[Read more]
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andria93 replied to the topic The people we shall encounter in the field in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
As you mentioned when you work, you will get involved with different people with different background and personality. Having people with different background and experience helps the whole team and the project in general if you utilize the resources well. Diversity helps to build a strong team and progress or projects in my opinion. An example is…[Read more]
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andria93 replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 6 years, 8 months ago
I think most of us have a feeling toward animals used in the science experiment and think it is unethical. However, it is used to help the humanities, This experiments goal is to find medical treatment, medications, and implantation. Most of us think about the act as it is not ethical but if you tie it to the outcome of the experiment, I think it…[Read more]
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andria93 replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 6 years, 8 months ago
Will I think both of industrial and academia are important at the same time. We need current improvements and quick outcome to help in current time, as well as we need new discoveries and inventions to keep up with the new disease’s outcome. If no one starts researches of the previous generation, we would not get where we are right now of all…[Read more]
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andria93 replied to the topic This vs That in the forum Pre-clinical Device Development 6 years, 8 months ago
If I have the option to choose between both of research role in academia and industry, I think I would like academia more. It focuses more on the science behind it and gives you more time for a true output for the project. People do it out of personal interest and for purposes of discovery and improvement to help humans. However, I feel in…[Read more]
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andria93 replied to the topic Project Objectives in the forum Intro to Project Management 6 years, 8 months ago
I think the main objective of any project I worked on is to have a solution for the customer or a good offer to the market. Of course, the project has to be achievable and deliver a final product on expected time is important. You might have the greatest idea and can make it happen, but if there is no need for final outcome in the market you can’t…[Read more]
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andria93 replied to the topic Project Manager Experiences in the forum Intro to Project Management 6 years, 8 months ago
I’ve worked with two different companies as an engineer for the past 5 years, each has a different structural organization. For the first company, I like the team structural and how the PMs interact with the whole team even brainstorm with CO-Op for new ideas and project. I like the way they use to manage the project effectively in a timely manner…[Read more]
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andria93 replied to the topic Manager Vs Engineering in the forum Intro to Project Management 6 years, 8 months ago
As all of us agree that it is the best that managers come from the same industry and have a technical background, Communication is one of the most important to success a project. Actually, it is one of the major roles for PMs beside planing and other is to connect all the cycle and involve necessary member in order to get the job done efficiently.…[Read more]
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andria93 replied to the topic Thoughts on BME degree, "a little of everything" in the forum Introduction to Medical Device Development 6 years, 9 months ago
BME is a very broad topic as you mentioned, but I disagree with you that it is a master of none. You can have a various concentration within the BME master program. So, it is your choice to focus on one of the fields such as Biomedical instrumentation, Tissue engineering, biomechanics,…etc. So, your program over different fields in BME to focus…[Read more]
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andria93 replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 6 years, 9 months ago
As most of you mentioned how co-op and internship are very important during the undergrad period, as it helps you to build the experience and the connection. I’ve heard from a lot of people that a lot of the companies try to fulfill the full-time positions form the co-op or internship. they prefer someone know about the company and the product as…[Read more]
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andria93 replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 6 years, 9 months ago
I do agree with most of you on the pros and cons for academic vs industrial. Also, it was very clearly stated in the presentation. However, I think which one will have an argument based on their personal preference. SO, If you like academic more than industrial you can see a lot of good argument to support and vice versa. For me, I do like the…[Read more]
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andria93 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 7 years, 1 month ago
I’m more involved in the engineering, I didn’t have a clear information and understanding of project management. I only knew a little part of what I was involved on with the PMs. This class helped me a lot to understand the major concepts and cycle of project management role. what’s the full life cycle of developing a product form PM perspective.…[Read more]
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andria93 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial 7 years, 1 month ago
I agree with most of you. Also, it is very important to be clear and specific on what’s your need for the project. Make sure you do a good research and comparison before you chose your vendor. Also, for the major component of the project, we have to approve more that one vendor to back-up for any mistake. From my experience, validation and…[Read more]
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andria93 replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial 7 years, 1 month ago
I think there are so many reasons why people leave work. But, the most important ones I think most people leave for are bad management that destroys projects, Un-fairness and relation between team members. from my experience before, I left one position due to so many promises and never got true. Sometimes management decision effect affects the…[Read more]
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andria93 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 7 years, 1 month ago
I like the way my company motivates each team of us. We have 5 different full teams, each team consists of sales engineer, technical engineers, and PM team. At the beginning of the year, top management distributes the cotta of the year on the five team. which motivate each team to get their goal on monthly bases, quarterly bases, and yearly bases.…[Read more]
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andria93 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 7 years, 1 month ago
I think most of us had the same Idea is to have at least couple years of experience and then target a management level of a role. And, I agree with that. I would like to focus on one industry to learn as much as I can about it. Also, I do enjoy more hands-on work and testing rather than managing the tasks and people doing the work As it was…[Read more]
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andria93 replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas 7 years, 1 month ago
when you write the specification sheet, SOP or BOM list. It has to be as accurate as you can. one point of view that it will not affect the product in a negative way, which I agree with you for this product only. However, if you manufacture other product that can be used for different application or you will market that for a different market. the…[Read more]
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