As Viraj mentioned, the CAPA itself is used to find the route cause of non-conformity and a method to address the NC, while creating a way to prevent ...
We are actually doing an internal Audit either next week or the following. The biggest advantage about the internal audit is that potential issues can...
I have personally dealt with a non-conformity, on a material that we manufacture, the material failed one of the critical inspection areas within Qual...
Ambiguity of GMPs for start up companies are completing understandable, I believe that is is a learning curve for these types of companies, because th...
In a No GMP aspect, I use to work for a company that did not utilize GMPs, and the process to upscale a potential product from lab to production becam...
As technology improved, so has the ability to manufacture goods. I know from my experience, this improvement has constituted to an increase in areas o...
Based on the provided information, I agree with the assessments above, I believe that a change order would be needed and this change should be address...
I have never personally done a design change from an initial design standpoint, but I have made Engineering Change Orders on documentations post the d...
An example of risk that I have personally worked with was the creating of SOP's for in process checking, the SOP that was created ensured proper inspe...
In my opinion, I feel that Research and Development is probably your highest investment, you want to ensure that the product you are developing meets ...
As you mentioned, recalls may be detrimental to the reputation of a company. Particularly the possibility of litigation. Below I attached a link to an...
I completely agree, to be in business you have to have an the knowledge of industry and most importantly the ability to speak and negotiate with poten...
I agree with the comments above, it is difficult to point at which role would be the most critical for a project manager. If I were to take a guess, I...
I have heard from fellow coworkers of projects being "killed" because of a shift within the market or money is shifted to another project due to unfor...
I personally never had experience dealing with recalls, but I assume that are some costly side effects from a recalls such as tainting of the company ...