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 versed in conducting and managing clinical trials set forth by a company. This is…   Read more»

Cutting costs in clinical trials is a big plus especially for pharma companies that choose to outsource clinical trials overseas. According to the article listed below, India has become a popular location in conducting these clinical trials due to the…   Read more»

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 available from within the organization.

I think that internal audits can help streamline a business and find problems that perhaps a lax enviornment has perpetuated. Internal audits are more effeicient and can help spot problems in application of SOPs, safety hazards or even documentation control.

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 different paths and endless changes, revisions and updates. Projects that have been started already should…   Read more»

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 take the necessary measures, but I feel that most companies…   Read more»

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 their own quality and SOP in order to comply to GMP’s. Each business/company…   Read more»

One interesting form of validation I have performed before is surgeon validation as the end user. Working with specialty medical instruments, our clients were the physicians who gave us specifics of each individual instrument or implant. This could range from…   Read more»

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 and calibration schedules as well as procedural protocols for the entire process….   Read more»

I’ve had similar experiences when moving manufacturing and assembling from one facility to another. Quality will always call for a complete validation for all aspects of the process moving. While you can and successfully argue with and rationalize certain aspects…   Read more»

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 maintains manufacturing, sterilization, QC as well as produced quantities of any specific lot…   Read more»

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 repeatable as possible as was stated above and also to ensure…   Read more»

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 the interpretation up to the test engineer while others leave very little…   Read more»

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 a product simply not able to meet a spec. If a root-cause analysis…   Read more»

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 this product were to change, the DHF should be updated…   Read more»

I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, drawings and verification…   Read more»

This course has been very helpful in looking at some of the other areas of the medical device industry that I have not been exposed to. Not only that, but the interaction between other students with lab experience or work…   Read more»

Currently, I work for a company that employs the functional organization structure. This helps in allowing all the smaller specialized groups to focus on our certain tasks at any specific point of a project. For instance, in R&D I’m solely…   Read more»

Hi, Looking at these different types, the last one in particular stands out to me for certain reasons. First, the fact that the directorate have an influential vision that is applied across the company and its different branches. This circular…   Read more»

I have to agree with your suggestion of subscribing to a database rather than buying documents one off. This creates a much more sustainable business model for these organizations by ensuring that subscribers will always have access to these articles…   Read more»