Top Regulatory Tips: Tips 5 & 6

Wednesday, March 11, 2009

Part 3 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Previously:
« Tips 3 & 4

Next:
Tips 7 & 8 »


Tip #5: Put together a complete team

It takes input from a variety of disciplines to ensure FDA's needs are met. Science and engineering are critical to product design and development. Along the way, other areas of expertise should be included such as clinical development, regulatory affairs, quality assurance, quality control, process development, marketing and sales. These disciplines may not always agree and will likely have competing requirements. But it's critical to be making business decisions with each of these voices in the mix ... otherwise it's likely you'll overlook something critical.

Tip #6: Educate and traing the entire organization on regulatory

If an organization is going to be successful in diagnostics, it's overall "Regulatory IQ" needs to be very high. Everyone in the organization from the Board of Directors to the technicians on the line need to understand the regualtory and quality environment. I like to call this concept Regulatory Sophistication. In the most successful organizations, knowledge of FDA fundamentals is simply expected.

We're in the middle of the week ... hopefully these tips will keep you going through Friday!

Tags: Best Practices, FDA, FDA 101, QSR

Part 3 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Previously:
« Tips 3 & 4

Next:
Tips 7 & 8 »


Other Blog Authors

Dylan Reinhardt
Dave Kern
Steve Gutman
Jo-Ann Gonzales

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