anywilliams@msm.edu

Forum Replies Created

RE: Does the FDA guarantee safety?

I don't think the FDA guarantees safety, however, I do believe that the organization tries its best to ensure safety. With both FDA-approved and Non-FDA improved, one should use their best judgement. ...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: organizational skills for QC

I am currently working at a cell and gene therapy company. Recently, there was an incident that resulted in failure of a process and sterility tests. After doing a root cause analysis, upper managemen...

In forum Quality Control and Quality Assurance

2 years ago
RE: Responses to Public Health Emergencies

I think the FDA could have been proactive in informing the public of vaccine facts. The pandemic made way for misinformation to be shared, which put a lot of people in harm's way. The FDA could have a...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: The Five Phases of Medical Device Development

@magan-rhodes If I were developing a device, I would finish a task before starting a new task. I like the feeling of knowing I am working towards a goal and I have checked the box and I am on to the n...

In forum Pre-clinical Device Development

2 years ago
RE: Failure's of Pre-Clinical / Clinical Research

@rd389 I can only imagine how terrifying that must have been. Was the overdose the result of poor GLP or a technician error? Was a study plan written and received by a Study Director? It seems like th...

In forum Pre-clinical Device Development

2 years ago
RE: Species in Animal Testing

@danieshat1 As a science minded person, I agree that testing should be conducted on species with similar genetic makeup as humans. However, as an animal lover, I think regulations regarding testing on...

In forum Pre-clinical Device Development

2 years ago
RE: Academia or Industry Preference?

Although my personality traits would fit in academia, my life goals are more suited for industry. I enjoy helping people, I'm curious, and enjoy challenging tasks. However, my life goals are to direct...

In forum Introduction to Medical Device Development

2 years ago
RE: Project Management Drives Changes

Do you think project managers are required to be "people persons"? Are social skills a requirement for project management? I think you have to be a people person to be successful in project management...

In forum Intro to Project Management

2 years ago
Project Management and Artificial Intelligence

Only 35% of projects today are successfully completed. This rate leads to an overwhelming amount of wasted resources. Researchers, startups, and other organizations are beginning to apply artificial i...

In forum Intro to Project Management

2 years ago
RE: Milestones Missed: Failure or Success?

I don't consider missed milestones a failure or success but as a new opportunity. This is a chance to regroup, analyze the steps taken, and try again to make the milestone. One should ask questions al...

In forum Intro to Project Management

2 years ago
RE: Changing Careers

I think changing careers is a great idea. We have been asked since grade school, "What is your dream job?" or "What do you want to do when you grow up?" Hardly ever do we consider more than one career...

In forum Introduction to Medical Device Development

2 years ago
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