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sns34
@sns34
Eminent Member
Joined: Nov 6, 2016
Topics: 0 / Replies: 37
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RE: Unexpected Clinical Study Results

Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA sta...

7 years ago
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RE: Types of Clinical Studies

Recently, I was involved in a single blind user study at work that involved our production parts and an R&D part that will be available on the mar...

7 years ago
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RE: Clinical Study Location/cost vs. results

The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-sav...

7 years ago
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RE: Management Responsibility

Hi Fady! Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring f...

7 years ago
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RE: CAPA

Hi All, I would also like to agree with all of the responses above. To put it in simpler terms, Corrective Action is based on a nonconformance event ...

7 years ago
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RE: Audits

Great question! Gh56 goes into wonderful detail about the pros and cons of conducting an internal audit and I’m sure all students can agree with his r...

7 years ago
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RE: Improving GMPs

GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that pr...

7 years ago
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RE: No GMPs

I agree with other students’ input in regards to companies choosing to not have GMP. GMPs typically cause companies to invest in a large sum of money,...

7 years ago
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RE: Discussion Topic: Vagueness of GMP's

Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general r...

7 years ago
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RE: Discussion Topic: Differences between ISO and FDA

Hi Dr. Simon! The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control a...

7 years ago
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RE: Process Revalidation

If the equipment gets moved from one location to another, I do not believe that all processes have to be revalidated. The reason the quality team argu...

7 years ago
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RE: Holistic Qualification

Hi Chris! The ideas of the holistic engineer embodies the point of view than an engineer needs to consider the whole system, the body of work that ma...

7 years ago
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RE: Standard Operating Procedures (SOP's)

Hi Luisa, I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily pr...

7 years ago
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RE: Discussion Topic: ECO's

Hello! To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might...

7 years ago
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RE: Discussion Topic: Post-market surveillance

The FDA uses post-market surveillance to monitor the safety and effectiveness of medical devices once they are on the market. It is a regulatory requi...

7 years ago
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