About Lori
Lori Carr, RAC (US), CQA (ASQ), RABQSA
President and CEO of Lori A. Carr, Inc., is a Principal Consultant in the Medical Device regulated industry.
Lori has more than 30 years experience in the medical device industry. She was a Medical Device Specialist FDA Investigator in both the Cincinnati and Denver District Offices of FDA. She conducted international and domestic inspections of medical device facilities (including Bioresearch) and trained FDA Investigators in conducting medical device inspections.
As an FDA regulatory compliance consultant, Lori has performed numerous quality assurance audits for medical device companies and clinical sponsors. She has created and implemented Quality Management Systems and provided guidance on quality, regulatory, and compliance issues throughout the world. Her clients include companies that have received FDA Warning Letters, are under FDA injunction or have had product seized by FDA, or are seeking FDA approval/clearance for marketing their products in the United States.
Medical Device Specialist
In her capacity as a Medical Device Specialist, she conducted numerous domestic and international inspections to ensure compliance with applicable FDA regulations including routine GMP, Pre-market (PMA), 510(k), and directed inspections from the Center of Devices and Radiological Health (CDRH) while working in both the FDA Denver and Cincinnati District Offices.
Lori earned a Bachelor’s Degree in Chemistry from Xavier University and was a 2005 graduate of the federal government’s Office of Personnel Management Leadership Development Class.
In 2010, Lori obtained the U.S. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Certified Quality Auditor (CQA) certification from the American Society for Quality (ASQ). In 2014, Lori obtained the ISO 13485:2003 Principal Auditor Certification from Exemplar Global (RABQSA), with an update to ISO13485:2016.
In 2018, Lori added the MDSAP (Medical Device Single Audit Program) and EUMDR Certifications to her repertoire of auditing competencies.
FDA Medical Device Regulations…
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Latest News
How much will AI help in the next pandemic?
Scientists use Artificial Intelligence (AI) to prepare and prevent future pandemics: The National Science Foundation is funding the development of a machine learning tool that analyzes posts on social media site X to detect early signs of a pandemic, predict outbreaks and evaluate possible effects of specific public health policies. The Coalition for Epidemic Preparedness Innovations has funded development of a tool called EVEScape that predicts the behavior of SARS-CoV-2 and other viruses. Meanwhile, drugmakers such as AstraZeneca are using AI to screen antibody candidates, which could help them develop vaccines and antivirals in the event of a virus outbreak.
FDA to Investigate Safety of Toxic Metals in Tampons
FDA to investigate tampon safety after testing finds heavy metals: The FDA is investigating possible effects of toxic metals in tampons after a study in the journal Environmental International found traces of lead, arsenic, mercury or other metals in 14 brands of tampons. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use,” the agency said.
New clues to how placebo effect works could lead to drug-free treatments for chronic pain: Scientists “reverse engineer” placebo effect in mice by stimulating brain areas involved in pain-relief response
Placebo effect relieves chronic pain in mice: A study published in Current Biology has demonstrated that the placebo effect could be used to relieve chronic pain in mice by conditioning them to associate certain environments with pain relief. This suggests that similar strategies could be used to manage human pain, such as by increasing the effectiveness of pain medications by combining them with the placebo effect.
How starfish lose limbs (on purpose) and survive: A neurohormone similar to one present in humans could help starfish regrow limbs.
Lost starfish arms could bolster regenerative medicine: Similar neurohormones in starfish and humans could help scientists better understand the molecular processes behind the animal’s ability to regenerate limbs and lead to advances in regenerative medicine, researchers write in a Current Biology paper based on study of the species Asterias rubens, the common sea star. In humans and starfish, cholecystokinin-type neurohormones set off changes in target cells by binding to specific receptor proteins on the cell surface, which causes gallbladder contractions in humans and muscle contractions in starfish that allow them to detach their arms, then close the wound.
Atlantic Veterinary College testing new drug for heart tumors in dogs: Propranolol is typically used to treat vascular tumors in children
Drug that shrinks children’s heart tumors might work for dogs: Propranolol is used to treat hypertension, atrial fibrillation and pediatric vascular tumors, and now researchers at Atlantic Veterinary College are running a study to see if the drug can shrink heart tumors in dogs. Canine heart tumors are not rare; however, many dogs do not show signs of illness until the tumors are advanced, so finding enough dogs for the study may be a challenge, says veterinarian Abigail Martin, the Co-Lead Investigator and a second-year cardiology resident.
Brain Scientists Finally Discover the Glue that Makes Memories Stick for a Lifetime: A long-running research endeavor reveals key chemical players that cement memories in place — and still more have yet to be discovered
Studies with rodents advance our understanding of how memories form: A new study in Science Advances builds on previous research with rats by demonstrating that the interaction between protein kinase Mzeta and the targeting molecule KIBRA is essential for memory formation, with tests showing that disrupting this interaction disrupts memory in mice. Senior Author Todd Sacktor recognizes the therapeutic potential of this research and envisions the possibility of memory rejuvenation through gene therapy.