I haven’t personally signed a non-competent agreement form. However few of my colleagues did and they were having a tough time after their previous jobs. One of them have to be constantly working with her lawyer for getting approvals to…   Read more»

Very good question! I was getting trained on ‘lawsuits and bribery issues’ at my new job a couple months earlier and I thought it the same way. But then I realized that breaking one small rule can lead to breaking…   Read more»

It has been a very helpful course for me as I am coming from a pure biology background. Overall, I got to learn how an industry or a company runs and work together to develop a new product. In this…   Read more»

I think it all comes down to a proper communication within the company. In order to solve any type conflict, it is important to communicate and engage in conversations that could solve it. That can be done via team meetings….   Read more»

I think it depends from person to person. If it was me, I would chose someone I already know and we could collaborate to learn and work together. However, we don’t always get the choice so in that case I…   Read more»

I personally haven’t encountered this type of scenario. However, avoiding any step during the verification process puts a huge risk tot he patients and customers. Some of the steps can only be identified by certain personnel and not others. Therefore,…   Read more»

The FDA explicitly defines the term: “process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. “ The steps of process validation include: 1) Process design 2)Process validation or process…   Read more»

The purpose of design control is to make sure that a plan has been made to be implemented by the company and manufacturer that ensures that all final requirements of the design are met during the process and development. Design…   Read more»

Definitely clinical studies are necessary in order for a drug/product to be approved by the FDA. It is true that people who are participating in the trials can get affected if the study goes wrong or the drug/medical device doesn’t…   Read more»

I agree with you that CRO would be a better place to work, especially because it is smaller and it gets easier for the employees to be known to each other, grow together and have fun while working. There is…   Read more»

I would not chose either marketing or sales since I am still enjoying the science and engineering field a lot. However, if I had to chose one, I would chose marketing because I would know how advertise and sell the…   Read more»

From my prior experience as a sales person, I think ‘manipulating’ is not quite the correct term to be used in marketing. Brand advertising and management does focus on the positive sides of a product and I think ‘persuading’ is…   Read more»

Emotional intelligence or knowing and managing emotions is one of the most important tools of success in professional and personal life. Accepting, embracing and managing our own feelings and behavior and being able to cope with the surroundings despite what…   Read more»

I think being a little picky about company depends on a lot of the factors. When I was a new graduate, I was targeting to get into a specific company which is very reputable and well established. But because I…   Read more»

I agree with you. I also think that it is beneficial to start with a private company. But for me, I gave a lot of priorities to learn what and how each departments within the company contribute towards the financial…   Read more»

I personally think that a recent graduate can learn a lot if they start from a smaller company or even a company that is currently going through the growing phase. Having a little to no specialization in the very beginning…   Read more»

Quality control is very much dependent on the process, whether an analyst is strictly following the SOP (Standard operating system), being compliant, documenting anything unusual and getting approval from QA either to continue or pause, having the batch records reviewed…   Read more»

Based on my past work experience I have faced some difficulties about implementing my ideas and introducing my scientific knowledge into the procedure I was hired to work on. It seems that a simple change cannot just happen as quickly…   Read more»

I recently started working at R&D. I worked for manufacturing for the last 3 years. Therefore, I have extensively seen how quality can be important. Working at R&D makes me realize how quality could be a little bit annoying when…   Read more»

Very good point! I totally agree that a new device should not be compared to a device that was approved 40 years back. Science and technology has been changing and so are our approaches to the research. However, I think…   Read more»