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tme3
@tme3
Eminent Member
Joined: Oct 31, 2016
Topics: 0 / Replies: 24
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RE: CROs

Using a CRO can usually over an objective assessment to a company when it comes to its drug/device and the resultant outcomes. CROs are usually well v...

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

Cutting costs in clinical trials is a big plus especially for pharma companies that choose to outsource clinical trials overseas. According to the art...

7 years ago
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RE: Internal Audits for small organizations

In my experience, a contractor is usually hired or an external auditor is hired for such occasions. This is standard practice if no resources are made...

7 years ago
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RE: Audits

I think that internal audits can help streamline a business and find problems that perhaps a lax enviornment has perpetuated. Internal audits are more...

7 years ago
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RE: Discussion Topic: When Quality Systems change in the middle of a project

I feel that existing product and documentation should be grandfathered in, since the time and money to extend these changes could lead down a many dif...

7 years ago
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RE: No GMPs

I feel GMPs purpose is noble, but in practice it is more of a hassle to a company rather than a benefit to a consumer. GMPs can force companies to tak...

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

I feel the ambiguity does just that, provide a framework for these companies. Since there is at least a base in place, each company can then place the...

7 years ago
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RE: Types of Validation

One interesting form of validation I have performed before is surgeon validation as the end user. Working with specialty medical instruments, our clie...

7 years ago
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RE: Discussion Topic: Playing with IQ, OQ, PQ

Hi Viraj, I agree with your approach but I believe you can to the following points: IQ - In addition to the manuals, you should call out maintenance...

7 years ago
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RE: Process Revalidation

I've had similar experiences when moving manufacturing and assembling from one facility to another. Quality will always call for a complete validation...

7 years ago
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RE: DHF vs. DHR

As many have already commented on both DHF and DHR, the FDA actually has some form of DHR database with the new GUDID and UDI initiative. This maintai...

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

If the product or process is still in a research phase or even development phase an SOP is needed either way. This is to ensure the tests are as repea...

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

Chris, I see this all the time on both ends of the spectrum when reviewing SOPs. There are protocols that lack any clear directions and leave much of...

7 years ago
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RE: Regression Verification and Validation

In an failed V&V testing portion of a new product could point to many factors such as poor design, test method, test operators or as you suggested...

7 years ago
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RE: Discussion Topic: Is the DHF a living document?

I believe that the DHF should be a living document. This is due to the fact that many other components of a product may be interlinked. If any part of...

7 years ago
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