Our Services

Consulting

Pinpoint advises and consults by providing tools and processes in a systematic approach to a client’s needs in achieving compliance and conformance to regulatory interested stakeholders.  Whether it be the formality of approval and certification, or the rigor of critical control points, the outcome is the same: Prudent navigation in the sea of risk. Laws are established, regulation is written, and guidance is interpreted to provide application in the safest manner for arriving at a complete and successful destination each and every time.

 

Pinpoint’s objective is to provide such project applications in any systematic approach.  Being sensitive to the client’s needs sets the stage for the consideration of delivery in any project. Cost, timing, resources and requirements all drive the development of a scope of work (SOW).

Training

The learning experience is where the endpoint of application and use meet.  In order to do this the qualification effort can seem tireless.  Planning, alignment and application must all be in balance, or the effort is wasted.  But the other prudent factor is deployment. This is done through genuine, insightful and earnest application of the mentor as teacher.

 

The team at Pinpoint convey these qualities in every area of expertise that is offered.  An anecdotal segway, patience, listening and assimilation all come together to make the method of the mentor while keeping total regard for process.  Pinpoint uses a collaboration software tool called Coursetune™ to manage all facets of the learning management process. (www.coursetune.com)

 

Pinpoint additionally offers training for internal auditors and training of Qualified Individuals who conduct Food Safety Plan activities such as developing and reviewing a food safety plan and risk-based preventative controls, gathering validations, and verifying records as required by  Title 21 Code of Federal Regulations Part 117 for the Preventive Controls “Qualified Individual”.

Assessment

To know what’s best is to understand the inner workings of things, all the while, using a standard of excellence as the gauge for improvement.  The best way to do this is to establish a mental and documented library of the good, bad and the ugly when evaluating a process, product, method or state of events.  An assessor must be able to tag an item of interest, or assignment, with the constraints, restraints, requirements and regulation to provide unequivocal decisiveness regarding status. Only then can a correction, improvement and action by assessed to its order of magnitude based on risk. These are the qualities of an auditor/assessor during any level of investigation.

 

Pinpoint has the library, the tools and the experience to execute such projects. This includes quality (mock) audits, due diligence audits, facilitated problem-solving, gap analyses and supplier qualification audits to name a few. The payback is in the results of knowing the standard to which any of these are to be performed. These may be done on-site or virtual-based using applicable media-technology.

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Latest News

ISO 13485: Change – Do I Have To?

UL and MasterControl published “ISO 13485- Change? Do I have to?” article, by Emergo Expert Linda Chatwin and MasterControl Expert Walt Murray. Click here to view.  

SO 13485: 2016 Part 3: Getting Ready for changes

ISO 13485:2016 Part 2: Getting Ready for changes

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