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bb254
@bb254
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Joined: Jan 20, 2017
Topics: 13 / Replies: 100
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RE: Process Validation vs. Verification

Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we ...

7 years ago
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RE: Validation Expiration

I never came across an expiration date for a validation. If an equipment was validated 30+ years ago and is still operational without any new changes ...

7 years ago
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RE: CAPAs: Proactive vs Reactive

From a medical device company perspective, it is better to have preventative CAPAs than reactive CAPAs. At my current employment, we have both prevent...

7 years ago
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RE: Technical Writing Skills

Technical Writing courses are not given to students as a priority when in actuality the work industry requires an individual with good technical writi...

7 years ago
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RE: Maintenance & validation

When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture....

7 years ago
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RE: Comparing Knowledge of FDA, EU, etc before and after this course

Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one ...

7 years ago
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RE: Validate or Not

As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefor...

7 years ago
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RE: Simulation 1: Faulty Quality System

While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. Thi...

7 years ago
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RE: How to write SOP ? Which SOPs are for cGMP ?

SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, proce...

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

SOPs are grilled into engineers minds ever since their first day at work. Within the medical company I work at it is mandated to have SOPs for every ...

7 years ago
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RE: Does your company use ECOs?

The current company that I work for uses ECOs in the form of change notices as Julienne has stated above. The process of implementing a change within ...

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

One advice that my manager told me when dealing with a complete rewrite of an SOP or creating and SOP is to make it “idiot proof”. This terminology i...

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

The company I work for does utilize a Design Specification document as Dr. Simon had described in this week’s lecture. It includes a design matrix th...

7 years ago
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RE: Regression Verification and Validation

From prior experience, when a verification/validation had failed I was obligated to redo the verification and validation per the updated specification...

7 years ago
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RE: DHF vs. Tech File/Design Dossier

Document History File is more useful than a Tech File in terms of traceability. Document History File is a living document, it contains any mistakes o...

7 years ago
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