Forum

Viraj D
@vnd4
Trusted Member
Joined: Oct 31, 2016
Topics: 4 / Replies: 50
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RE: Unexpected Clinical Study Results

As others have mentioned, if adverse side effects are observed after the product was used/administered by a patient during a clinical trial, it is mos...

7 years ago
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RE: career path

With my current experience working in the industry, taking part in clinical trials can be a very daunting task with quite a lot of paperwork. Finding ...

7 years ago
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RE: Simulation Experience

These simulations definitely helped understand the topics we learned during class. I believe the last simulation we are currently working on is the mo...

7 years ago
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RE: Significant risk vs Non-significant Risk

As the person above provided examples, an easier way to observe the difference between significant risk medical devices and non significant risk devic...

7 years ago
Topic
Replies: 8
Views: 1311
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RE: CROs

If a CRO is not able to deliver the expected results I am sure there is language within the contract specifying this possible outcome and steps to tak...

7 years ago
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RE: Non-Conformity

From my experience with a CAPA usually an ER is filled out with the non-conformity which initiates the CAPA process. An example that occurred in my co...

7 years ago
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RE: correction vs corrective action

As mentioned above, usually corrections and CAPAs go hand in hand. Corrections are immediately done to eliminate the non-conformity in real time. Whil...

7 years ago
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RE: Audits

From my experience with dealing with internal audits, the purpose of it is to prepare the company from a major audit that would occur by the FDA. It a...

7 years ago
Topic
7 years ago
Replies: 12
Views: 967
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RE: Discussion Topic: Vagueness of GMP's

I believe in general as a company starts to focus on new processes or focuses on a new project there will always be a learning curve. However, for sta...

7 years ago
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RE: No GMPs

As the others have mentioned, if there were no GMPs I believe most companies would not follow the guidelines set forth for good manufacturing processe...

7 years ago
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RE: Product Life Cycle Curve

As others have mentioned, the development phase is the most expensive due to the time and effort from the design generation stage. Additionally, durin...

7 years ago
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RE: product manager role

I believe the product manager has many roles which include, identifying profitable opportunities that meet market needs, launch products into the mark...

7 years ago
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RE: Interpersonal Skills

I agree with the comments above where a successful team leader should have good interpersonal skills. It is essential for the leader to additionally h...

7 years ago
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