Patrick Stone

President, lead consultant, author

TradeStone QA

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.

Thu, 09/03/2015 - 16:29
U.S. Drug Shortage Hits Patients, Pharmacies Hardest Passively waiting for supply chain improvement isn’t the answer
Thu, 09/03/2015 - 16:29
The corner drug store isn’t currently affected by many drug shortages; instead, the pain is being inflicted on a vulnerable group of patients in hospitals today. The U.S. Food and Drug Administration (FDA) “officially” list the shortage of drug…
Should the FDA Get Tougher on Investigational Review Boards? Why not to abandon the last line of defense for patient safety?
Thu, 06/04/2015 - 16:34
The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over. This is troubling. My first question: How are IRBs going to assure that clinical investigators…
The FDA’s Action Plan Demands Some Industry Action, Too It may take years to iron out some wrinkles, but it’ll be worth it
Mon, 05/04/2015 - 13:13
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document. This “Plain Jane” …
Former FDA Inspector’s Crystal Ball Outlook is cloudy with a chance of inspected meatballs
Wed, 10/02/2013 - 13:24
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.…
Sold: Electronic Medical Records to the Highest Bidder HIPAA laws are unequal to the task of safeguarding e-records
Fri, 07/19/2013 - 11:41
How often do we see Health Insurance Portability and Accountability (HIPAA) violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large-scale security breaches and, sometimes, reports…
It’s Time for the FDA and States to Step Forward for Public Health It shouldn’t take nearly two years to conduct a compound pharmacy inspection
Tue, 12/11/2012 - 10:52
It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health? The recent news is troubling. For example, a shipment of…
Give the FDA More Authority Over Compounding Pharmacies They are currently protected from the big bad regulatory wolf
Thu, 10/25/2012 - 10:13
Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’t distribute outside their home state (no…
Is the FDA Better Off Than It Was Five Years Ago? Many needed improvements are too logical for government comprehension
Thu, 09/06/2012 - 12:59
During a debate with then-President Jimmy Carter, Ronald Reagan famously asked Americans if they were better off than they were four years previously. It worked for Reagan, so we’re going to try a variation of it here. Is the Food and Drug…
FDA Deserves Better Treatment Senate bill could speed drug delivery, but…
Fri, 06/08/2012 - 16:24
Speed up approval for new health care products and minimize a major drug shortage. Sounds good so far, right? Let’s hope lawmakers get this right with a new bill designed to speed delivery and avert shortages of life-saving medicines. Throughout…
Quality by Design Pilot Presents Industry with New Challenges The FDA will not let you have your cake and eat it, too
Mon, 09/19/2011 - 10:36
What products will be affected by the Food and Drug Administration’s (FDA) quality by design (QbD) stipulation, as outlined in its report, “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”? It will apply to new marketing…