From my experience, GMP (good manufacturing practices) quality system documents are general but clear. As a new employee, the company trains you on the GMP regulations that the company upholds. If there are discrepancies, then many of the other employees will educate each other on it. Along with requesting for an updated GMP document. New…[Read more]

GMP represent good manufacturing practices, all medical companies have a list of regulations for there standards for good manufacturing practices. The company I work for has not updated the GMP quality system document for a while. The reason is because the current GMP document clearly states the guidelines for the type of manufacturing practices…[Read more]

During my time at my company, I have not experienced a period when sales were on a decline. However, coworkers have told me what the company did in the past when the sales weren’t good. Upper management met up and discussed funding a new R&D project which would increase sales. Meetings were held to figure out how we could maintain or increase o…[Read more]

The development phase is the most expensive phase within product life cycle. The development phase requires testing and creation of the products. Within an undergrad course that I took, we had to develop a product that fulfills a current market gap. We followed the product life cycle and the most cost came from the development phase. Our ideas of…[Read more]

I have gone through the scenario where a project was to increase sales but in the middle of the project the marketplace was no longer attractive to the project goal. As a result, many meetings were scheduled to discuss the corporate strategy, resources and cost. As a collective decision, it was decided to place my project on hold because the…[Read more]

My first project as a Biomedical Engineer was to obsolete a product line that was sold to Japan. Based off marketing’s decision the cost to produce the product did not match the profit compared to other product lines that the company was manufacturing. Due to the obsoletion of the product from the market, I was responsible for transitioning all a…[Read more]

From experience, a project manager should be well informed of the current industry and market data that their product is apart of. The medical device industry is always growing and the need for medical products will always be a necessity. Therefore, being in tune with what the market gaps are for the medical industry your product falls under is…[Read more]

When deciding to sign a contract with a customer you need both interpersonal skills and business knowledge. From experience working with suppliers, you need to be knowledgeable of the product, risks, financial obligations required in persuading your team and vendor to commit to a contract. In addition, you need interpersonal skills especially as…[Read more]

Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we rely on validation for new fixtures and processes. Verification are stated in procedures as 100% inspection to verify that the device is being built according to our specifications. Validation are…[Read more]

I never came across an expiration date for a validation. If an equipment was validated 30+ years ago and is still operational without any new changes to the fixture than the original validation is still valid. The only instances that I can see a need for a revalidation is if an engineer notices that the validation does not meet the company…[Read more]

From a medical device company perspective, it is better to have preventative CAPAs than reactive CAPAs. At my current employment, we have both preventative and reactive CAPAs. In recent meetings our manager began giving out multiple preventative CAPAs to balance out the number of reactive CAPAs that have been submitted. A preventative CAPA shows…[Read more]

Technical Writing courses are not given to students as a priority when in actuality the work industry requires an individual with good technical writing skills. When starting a full-time position as an engineer, I had to validate a new automatic fixture for production use. The specification document and preventative maintenance documents…[Read more]

When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture. If so, then it can escalate to a CAPA through the development of a CRF. In terms of validation, it does not need to be revalidated unless it is moved from the production floor. If it is moved from…[Read more]

Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one of Dr.Simon’s courses my spring semester I knew that in order to get my tuition worth of masters program I needed to take all his courses. I learned so much about the design control process and p…[Read more]

As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefore, as a startup company, the employees will learn the standards of the company through SOP documentation. There are general guidelines on how to go about the validation and verification process w…[Read more]

While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. This does create traceability however it ends up creating a lot more work in the long run. Just to update one document, multiple other documents must be updated to state the new revision of the d…[Read more]

SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, procedure, documents/ fixtures affected, forms and attachment sections. All SOPs should be written in a concise format that does not lead to questions. When an auditor reviews an SOP they will look up all…[Read more]

SOPs are grilled into engineers minds ever since their first day at work. Within the medical company I work at it is mandated to have SOPs for every fixture or process that is in place. It is not just focused on the research phases of developing a product. It is crucial to begin creating SOPs within the research development phase because it…[Read more]

The current company that I work for uses ECOs in the form of change notices as Julienne has stated above. The process of implementing a change within an SOP requires engineering to supply a redline and final draft of the suggested changes to document control via a software format known as a CN. Once the CN is approved by document control then…[Read more]

One advice that my manager told me when dealing with a complete rewrite of an SOP or creating and SOP is to make it “idiot proof”. This terminology is used to make it clear that whatever is being stated in a procedure should:
1. Be clear: Nothing should be left for assumptions or questioning.
2. Be Concise: Get to the point, remove any detail whi…[Read more]