Blog Posts with Tag: Best Practices

The Spirit of GLP
A Best Practice for IVDs
Tuesday, June 17, 2014
Process Performance Qualification (PPQ) Lots
So, how many lots are required?
Tuesday, June 10, 2014
The Case for Risk-based Monitoring
Better the devil you know...
Thursday, June 05, 2014
The Case of the Dangling Validation
From the files of a statistical gumshoe
Tuesday, March 05, 2013
Keeping RA/QA Staffs Current
Accepting regulatory change starts with staying current
Tuesday, February 12, 2013
"It's Just Software"
You can teach an old dog new tricks
Friday, January 25, 2013
Paper is (Mostly) Dead
How I learned to stop worrying and love eCopies
Thursday, January 10, 2013
The Essentials of Essential Requirements
The challenging part is trying to figure out which strategy of meeting the essential requirements works best for the manufacturer.
Wednesday, December 08, 2010
Assessing Conformity
The route is determined by intended use and risks to personal and public health
Tuesday, November 02, 2010
Implausible Deniability
Delegation is not a defense. Ignorance does not negate liability.
Tuesday, October 26, 2010
Relationships Really Do Matter
How you manage your partners is one of the first things an auditor looks for
Tuesday, September 07, 2010
The Wrong Raptor
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
Getting DTC Genomics Right
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010
Unicorns, Santa Claus and Instrument-Only Clearances
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
The Perils of Time Travel
Some questions you should ask (and FDA will ask) about your frozen clinical samples.
Tuesday, April 13, 2010
Patent (Had Better Be) Pending
The days of using the term as an empty threat may be ending.
Monday, March 08, 2010
Good Summary Judgment
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
Bells, Whistles, and the Quest for Clinical Utility
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 2009
Clinical Teamwork
Clinical trials can be a positive experience for manufacturers.
Tuesday, September 01, 2009
Enlightened Empowerment
The concept of giving people the power to do their job is sound, but it is frequently not well implemented.
Thursday, July 09, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
Making Progress by Crushing Dreams
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
Verification: It's Not Just a Phase...
There is more to verification, Horatio, than is dreamt of in your system evaluation!
Tuesday, May 26, 2009
And the Award Goes To...
Not every regulatory process is a joy, but projects like this can serve to remind us why all of this is worthwhile.
Friday, May 22, 2009
Careful with Claims
It can be frustrating to 'just know' your product can do more, but making claims that are not truly validated is simply unwise.
Monday, May 11, 2009
Too Good to be True?
Perfection is a worthy goal, but it's not often we get to see it out in the field.
Monday, May 04, 2009
A PMA Is Not the Kiss of Death
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
Know Your Audience
I have to hope that they might have thought twice about some of these choices if they had realized that FDA was attending the conference.
Wednesday, April 22, 2009
Turning Project Managers Into Project Leaders
A pack leader doesn't scream, get excited, or frustrated. They lead with what Cesar calls "calm, assertive energy."
Friday, April 03, 2009
Three Key Principles
Project Management in a Nutshell
Tuesday, March 24, 2009
What Do I Do With Project Management?
In an IVD firm, the project manager should be the de facto owner of the design control process.
Friday, March 20, 2009
Tips 9 & 10
Manufacturing before trials, Focus
Friday, March 13, 2009
Tips 7 & 8
Review contracts, public statements
Thursday, March 12, 2009
Tips 5 & 6
Teamwork, education
Wednesday, March 11, 2009
Tips 3 & 4
Prompt QSR, listening to FDA
Tuesday, March 10, 2009
Tips 1 & 2
Business planning, starting with design control
Monday, March 09, 2009
TBD or Not TBD
Ten tips to avoid common documentation errors.
Thursday, February 26, 2009
Your Process is Your Product
Making good, safe, reliable, robust products that meet the customer and the companies needs is all about the process by which it happens.
Monday, February 23, 2009

Recent Blogs

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!