From assessing to staff augmentation: We have you covered
Consultants consult, we resolve: By understanding your areas of opportunities, collaboration on alignment of risks and prioritization of improvement areas; we develop the action plan and engagement of the organization for complete resolution.
We focus on developing an integrated process approach for all elements of your Quality System, including providing IT solutions to meet the current and future needs of your organization. Learn more
We take a process approach; understanding risk management and that protecting the patient is the best way to protect your bottom line. Learn more
We specialize in Total Product Life-cycle system development: Concept, Development, Technical Transfer from R&D into Manufacturing, Production, Post-Market Support. Establishing a process approach for proper communications and hand-offs. Learn more
Over 200 Quality and Regulatory professional through training and provided mentoring oversight to over a dozen Vice President level professionals to enhance their quality, management and process effectiveness skills.
For years, I have been mentoring a successful Quality/Regulatory friend who recently asked for guidance on dealing with personal relationships, focusing on his career and personal relationships. We discussed how we have established goals and requirements in our business lives that we often overlook in our personal lives. Having mentored him professionally, my guidance was Read more about Developing Quality Relationships[…]
The childhood game of ‘tag’ is fun, I still enjoying playing with young children. However, in business the game of ‘tag’ is often used as an excuse for pushing responsibilities on to vendors/suppliers. How many times have you heard ‘the vendor didn’t process a document’ or the ‘supplier forgot to consider local or regional requirements?’ Read more about Tag you’re it…Supplier Quality[…]
Reading bedtime stories continues to be an important communication tool for young (and old) people. Antoine de Saint-Exupery’s classic, The Little Prince was part of the cycle for each of my children and now grandchildren. The great secret from the fox to the Little Prince, “It is only with the heart that one can see Read more about What is Essential is Invisible to the Eye[…]
The greatest life lesson occurred while in my High School Geometry class. During discussions of hyperbolic equations, the teacher turned around from the board to profound that, “Man is like a hyperbola, always striving to their asymptote.” It took me years and immersion into Buddhism to truly understand what he was conveying. In hyperbolic geometry Read more about Striving for perfection[…]
Three days after starting a new job, I met the CEO in the elevator and introduced myself. Without skipping a beat, he said he was familiar of who I was, stating that I was that highly paid “Quality Overhead”. I was brought in to help turn around the Quality area. About 2 months later, I Read more about Quality is not Overhead[…]
Struggle with explaining Regulatory Requirements to upper management? Regulated industries have two masters: the regulators and CEOs; so why not develop strategic tools to serve both? Let’s use a process approach to determine how well your current practices meet your organizational needs: Defining business practices that meet Regulatory requirements is key for delivering product, services Read more about Business Centric Solutions for meeting Regulatory Requirements[…]