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kak33
@kak33
Trusted Member
Joined: Sep 10, 2017
Topics: 2 / Replies: 56
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RE: Clinical Study Location/cost vs. results

I agree with the comments above that costs are a major consideration when outsourcing clinical trials. When there is a discussion about cheaper costs ...

7 years ago
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RE: AMDD

I think all undergraduate and graduate programs should considering adding courses like this because it gives students a glimpse of what it is like in ...

7 years ago
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RE: Non-Conformity

A couple of weeks ago my company had to place product on hold and initiate a CAPA because of nonconforming product. At a high level, a custom componen...

7 years ago
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RE: Management: Continuous Improvement

In addition to internal audits to improve quality, my company also hosts internal kaizen trainings for various process to make continuous improvements...

7 years ago
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RE: Management Responsibility

From my experience in the industry, this is a common problem in many departments. I’ve seen departments over loaded with work and the quality of the w...

7 years ago
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RE: FDA Considering Updating Quality System Requirements

The FDA anticipates publishing a proposed rule early in 2019 on aligning the two. The FDA was instrumental in the revision of ISO 13485, most of the P...

7 years ago
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RE: Improving GMPs

My company performs a yearly review of our manufacturing practices. However, I did find a publication by the NSF about changing your quality culture a...

7 years ago
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RE: Process Revalidation

I think it can get tricky when talking about process revalidation and what is required to qualify the equipment to be used in the process. In my opini...

7 years ago
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RE: CAPAs: Proactive vs Reactive

I think we can all agree that it is better to be proactive in MOST, if not all situations for the best interest of the business. I think it is also im...

7 years ago
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RE: Technical Writing Skills

I feel that my undergraduate career prepared me to write technical reports more than protocols. I am confident in my writing abilities, however, I sti...

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

I think a SOP should be used during the research phase but if not, I think it MUST be used during development. This way the engineers would be able ha...

7 years ago
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RE: SOP: how much detail before too much detail?

In my experience, I add as much detail as possible to SOPs such that there is no room for interpretation because our processes are so tightly controll...

7 years ago
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RE: Does your company use ECOs?

I currently work as a manufacturing engineer at a medical device company. My team is responsible for maintaining the on market device. We use DCPs (De...

7 years ago
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RE: Documents that are equivalent to a DSD

My company doesn’t fill out a DSD. However, we do maintain a traceability matrix that shows all of the verification and validation activities complete...

7 years ago
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RE: Discussion Topic: Verification vs. Validation

I currently work in manufacturing and I see a lot of instances when a design and process needs some form of verification or validation. We use verific...

7 years ago
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