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 29 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
First fetus-to-fetus transplant demonstrated in rats: The tissue developed into functioning kidneys and produced urine.
First fetus-to-fetus kidney tissue transplant with rats successful: In a “first of its kind” project, surgeons in Japan transplanted kidney tissue from one rat fetus to another that was still in the womb, said Study Leader Takashi Yokoo, a Nephrologist at Jikei University School of Medicine in Tokyo. The advancement is a step toward the transplantation of fetal pig kidneys into human fetuses.
A vaccine for bees has an unexpected effect: Honeybees immunized against bacteria also fought off a virus
Bees vaccinated against bacterial disease resist virus: Honeybee hives vaccinated against American foulbrood diseases were more resistant to a virus carried by varroa mites than unvaccinated hives despite having an equivalent number of mites, veterinarian Nigel Swift of Dalan Animal Health reported at the World Vaccine Congress. The vaccine, made by Dalan, might boost honeybees’ immune systems, Dr. Swift says.
Without support, many menopausal workers are quitting their jobs
Menopause – the unspoken challenge for female workers: For women between the ages of 40 and 58, balancing the effects of menopause with the demands of their jobs is daunting, with financial losses put at $1.8 billion, and sometimes impossible, with about a quarter of women in one survey saying they were considering leaving their jobs. Bristol Myers Squibb, Adobe, and Bank of America are among the few companies that offer menopause benefits, and grassroots campaigns like Menopause Mandate and Let’s Talk Menopause raise awareness about the issue.
How to get rid of NYC rats without brutality? Birth control is one idea
Can contraceptives prevent NYC rat overpopulation? The New York City Council is considering a proposal to try distributing rat contraceptives as a humane way to control the city’s rat population without the use of chemicals that harm nontarget species. The proposed pilot test would involve distributing male and female contraceptives encased in salty, fatty pellets in rat-infested areas.
WHO sounds alarm on viral hepatitis infections claiming 3500 lives each day
WHO reports on the global hepatitis crisis: The 2024 World Health Organization (WHO) Global Hepatitis Report reveals a rise in viral hepatitis-related deaths, making it the second-leading infectious cause of death worldwide, with over 6,000 new infections and 3,500 deaths daily. This is attributed to lacking diagnosis and treatment in many countries, although the WHO hepatitis elimination goal of 2030 may still be possible with expanded access to diagnostics, simplified service delivery, and increased funding for priority countries.
Congress Allocates $10 Million for Arthritis Research
New arthritis research program gets $10M from Congress: Congress has allocated $10 Million toward a new arthritis research program under the Department of Defense’s (DOD) Congressionally Directed Medical Research Programs (CDMRP), with funding opportunities expected to open by July or August 2024. Despite being under the DOD, the research funding from the CDMRP can extend to populations outside the military and is not limited to military treatment facilities, said Akua Roach, Program Manager for the CDMRP Arthritis Research Program.