I believe that the only responsibility that the sponsor cannot outsource to any CRO is the overall responsibility of the clinical study. I think that any adverse events, injuries and risks will be the responsibility of the clinical study sponsor…   Read more»

Hi All, I believe that all of you have touched upon very valuable points. I would like to emphasize that pre-clinical trials (animal trials) are not a safety indicator for many devices. For example, Inhalation devices are not usually tested…   Read more»

As everyone have mentioned, These simulations are a very useful tool to mimic what usually occurs in the industry. Although I sometimes think that they only scratch the surface of what actually occurs and the proposed solutions are not always…   Read more»

Hi Neb2, From my experience, you might have two functionally similar devices but they may have different risks. For example, an infusion pump that is used for normal IV infusion may be considered a non significant risk, while as an…   Read more»

Non-conforming materials is a very common issue that almost all manufacturers deal with on daily bases. it ranges from regular suppliers to product coming out of the line that does not meet specifications. The most recent non-conformity that have dealt…   Read more»

Hi All, Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked in a small organization, We always struggled to understand what should be done….   Read more»

Hi All, This is a very interesting discussion so far. I want to look at this situation from a different prospective. If I am a manufacturer that is looking to buy some parts or equipment from a supplier and I…   Read more»

Hi All, This situation is usually handled on a case by case basis. In some cases, when the regulation is changed or updated, guidance documents are issued to explain the timeframe of implementation and the criteria that must be met…   Read more»

This is a great question, and I am currently experiencing that in my current position. Most of the time, projects that are given the GO decision are executed till commercialization. Most of these projects are usually well planned, budgeted and…   Read more»

I agree with all the aforementioned comments that all these roles are crucial for a product manager. The one point that I have to elaborate on is the ability of the product manager to understand the factors that could affect…   Read more»

I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of product. The lot was inadvertently labeled as a different model number that looks similar….   Read more»

Hi Viraj, you did bring up a good point. Validation can occur at multiple stages along the manufacturing process. Your prospective validation example is relevant to the kind of validation that should occur while to ensure that the process is…   Read more»

Hi Andrew, I like the examples you provided for IQ, OQ, PQ for prefilled syringes, but I think that the IQ for a Syringe filling line may be a little different. For example the Installation qualification may include the following:…   Read more»

Hi All, I believe that Both the FDA and ISO have established similar requirements when it comes validation. The FDA requires process validation if the process cannot be fully verified by inspections or test. Some Manufacturers use In-line inspection methods,…   Read more»

HI Luisa, you raised a very good question that concerns many companies. A quality system is the backbone of any organization. it defines the structure of the organization as well as define the roles and responsibilities of each member in…   Read more»

Hi Chris, I have ran into your situation multiple times. SOPs are supposed to be written in very specific details. It is also supposed to be written in a step-by-step format in order to be easily followed. Each step in…   Read more»

Hi All, In my previous job I had to issue ECOs for many purposes including: – SOP Changes/updates – New SOP Release – Process Changes – Product Specification Changes – Documentation Updates The reason why we used ECOs in everything…   Read more»

I have gone through the same process a while back when I first started working with design controls. It was always confusing what is the difference between a DHR and a DHF. Reading definitions may not be very helpful until…   Read more»

Hi All, I believe all of you have identified so many ways that post market surveillance can be conducted. The main pitfall that I have seen manufacturers fall in most of the time is the understanding of the term post-market….   Read more»

I am one of the people that believe that DHF is a living document. Any changes to the Device Must be included in the DHF. I also believe that any changes have to go through a design transfer especially changes…   Read more»