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Welcome!
Choices & Prevention LLC provides
services to FDA regulated industries, their suppliers and medical laboratories.
- Developing and implementing
procedures that comply with regulatory requirements at the same time as streamlining the processes and making them easy for
all to follow.
- Developing and conducting
customized training programs
(i.e., Current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001, ISO
15189, Internal Auditing, Root Cause Analysis, Problem Solving, etc.) geared toward adult learners. Select
Courses, Lectures & Seminars for the current schedule.
- Conduct audits focusing on
regulatory compliance, process improvement and cost savings.
- Design validation protocols
to ensure requirements are adequately evaluated.
Manufacturers of medical devices,
biotechnology, pharmaceuticals, biologics, food and dietary supplements and their suppliers besides medical laboratories
can all benefit from services provided by Choices & Prevention LLC. Don't miss an opportunity to
utilize over 25 years of quality and clinical study knowledge and practical experience and a reputation of developing
and implementing processes that comply with regulations in a short period of time at a minimal cost.
Consider the following
questions to assess your company needs.
- Does your organization struggle to meet customer and/or regulatory
requirements?
- Do your processes yield high rejects?
- Is your quality system ineffective and/or inefficient?
- Are you having problems launching a new or modified product on time?
- Is your design control process cumbersome?
- Does your product fail once out in the field?
- Do you need help designing more robust validation
protocols?
- Is your company ready to acquire
another organization? Has anyone been assigned to conduct an assessment?
You have come to the right website if you answer yes to any of these questions.
Check out the rest of the site to find out more about my consulting business. Many of my services are covered by
state training grants, so definitely review Funds.

Newspaper Headlines
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... Start up company folds, facility does not meet cGMPs ...
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... FDA seizes product ...
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...Clinical trials halted due to manufacturing problems ...
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...Product recall ...
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...Organization does poor due diligence when acquiring company ...
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...New launch of product delayed due to manufacturing issues ...
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...High scrap rate causes company bankruptcy ...
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...FDA closes facility & prevents further shipments of product ...
Don't be part of this bad news. Prevent problems from occuring by choosing
Choices & Prevention LLC for your consulting services.
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