Transitioning out of the FDA into consulting or working elsewhere in the industry can be a challenging process. Several members of the FDAQRC team were former FDA employees and they shared some tips and tricks for making the transition smoothly. Read more here: https://hubs.ly/Q02FRXKp0 #regulatorycompliance #FDA #FDAtoindustry #transition #auditing #consulting #GxP
FDAQRC
Pharmaceutical Manufacturing
Cedar Park, Texas 9,370 followers
A fresh perspective. Trusted compliance solutions.
About us
FDAQRC offers specialized quality consulting, regulatory compliance and quality assurance for Pharmaceutical, Medical Device and Biotech companies. We provide customized, value-added solutions, processes and enhanced quality standards to optimize business efficiencies and minimize regulatory risk. We do more than audits; we collaborate with you to analyze your need and match the right expert to your situation. Our global team is recognized as experts in quality assurance and regulatory affairs providing expert advice to pharmaceutical, medical device and contract research organizations in pre-clinical, clinical and commercialized sectors.
- Website
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http://www.fdaqrc.com
External link for FDAQRC
- Industry
- Pharmaceutical Manufacturing
- Company size
- 11-50 employees
- Headquarters
- Cedar Park, Texas
- Type
- Privately Held
- Founded
- 2009
- Specialties
- Quality System Implementation, Gap Analysis Audits, Good Clinical Practice Audits, Risk Analysis, Due Diligence audits, Good Manufacturing Practice audits (Pharma/Medical Device), Remediation, Literature Review 505(b)(2), Good Laboratory Practice Audits, Pharmacovigilance, and Pre-inspection readiness audits
Locations
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Primary
100 E. Whitestone Blvd
Suite 148-262
Cedar Park, Texas 78613, US
Employees at FDAQRC
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Dr Phil Masters
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Steve Bliss
Vice President Of Business Development at FDA Quality and Regulatory Consultants (FDAQRC)
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Chris Zilich, MBA
Senior Quality Consultant Solid Dosage, Biologics, Biosimilars, Laboratory Diagnostics, Quality Systems Implementation Expert, Auditing, Inspection…
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Mark Lund-Conlon
Computer System Validation (CSV) Specialist providing guidance on regulatory validation and compliance on IT implementations and upgrades, and…
Updates
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Happy 4th of July! As we celebrate with friends and family, let’s honor the spirit of freedom and unity that defines our great nation. We hope everyone has a fun and safe holiday! FDAQRC will be closed Thursday, 4 July 2024, and Friday, 5 July 2024. We will resume normal business hours on Monday, 8 July 2024. If you require immediate assistance during this time, please call +1.866.400.8996 #independence #freedom #unitedstatesofamerica #USA #officeclosure #worklifebalance
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Our team enjoyed exhibiting in San Diego, CA for DIA’s 60th Global Annual Meeting! Industry events offer an amazing opportunity to discuss the field of regulatory compliance and emerging trends with our peers. Thank you to everyone who visited our booth and shared in engaging discussions with us! We are looking forward to DIA 2025! Check out our highlight clip of #DIA2024 below. #DIA2024 #DIA #conference #regulatorycompliance #chartingnewhorizons #GXP #pharma #networking #innovation
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We are celebrating 3 work anniversaries this month! Join us in wishing Michelle Copeland RQAP-GLP, RQAP-GCP, Erich Zirzow, MBA, and Brianna Rico a Happy “Work-iversary!” Thank you for all that you do. We are so happy to have you on our team. #workiversary #celebrate #companyculture #gmp #gxp #lifesciences
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In GCP, there are several factors that separate Quality Control and Quality Assurance. One example is that QC is typically product oriented while QA is process oriented. Check out our industry insight where Auditor Amy Fox explores the differences between QA and QC in GCP: https://lnkd.in/gNhdZT9N #GCP #qualityassurance #qualitycontrol #regulatorycompliance
Regulatory Compliance Trivia: In GCP, How does Quality Control (QC) differ from Quality Assurance (QA)? A. QC is process oriented, QA is product oriented B. QC reviews are based on SOPs, QA review is based on regulations C. QC is product oriented, QA is process oriented
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The FDA recently released a report regarding their two-day webinar about increasing diversity in clinical studies. The report discusses best practices to better include underrepresented communities, however, it is not formal guidance from the FDA. Read more here: https://hubs.ly/Q02DfWCj0 #FDA #diversity #inclusion #clinicaltrial #bestpractice
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Thanks for a great event, #DIA2024! Our team enjoyed making new connections in the Exhibit Hall, joining important conversations about where the industry is headed, and making time for team bonding! Did you miss us at the event? Fill out our form and we will contact you! https://lnkd.in/gPw9FA9n #DIA2024 #conference #exhibithall #regulatorycompliance #chartingnewhorizons #qualityassurance #GXP #GCP #GMP #GLP
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On June 19th, we celebrate a historic moment in US history that marks a time of liberation and a journey toward equality. Juneteenth is a time to honor Black Americans’ heritage and resilience. Let’s commit to continuing the fight for diversity and inclusivity in our communities and workplaces. Happy Juneteenth from FDAQRC! #freedomday #embracediversity #Juneteenth #diversity #equity #inclusion
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#DIA2024 is almost over, and we are sad to be packing our bags so soon. But while we’re still in town, don’t miss your chance to discuss how FDAQRC can be your passport to regulatory compliance. 🛂✈️🌎🧳 Today is the last day to visit us at Booth #1226 in the Exhibit Hall! Stop by to learn how FDAQRC can assist you on your regulatory compliance journey - it’s smooth sailing when you partner with us! 😉⛵️ Ask about our travel goodie bags for you to take home and get your last minute entry in for our giveaway! 🎧 Not attending #DIA2024? Fill out our contact form and someone from our team will get back to you: https://hubs.ly/Q02Cf4yJ0 #DIA2024 #conference #exhibithall #regulatorycompliance #chartingnewhorizons #qualityassurance #GXP #GCP #GMP #GLP
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From seed to sale, FDAQRC cultivates a customizable path for all of your regulatory compliance needs. With experts across all GxP areas, FDAQRC can assist you in any stage of your project’s lifecycle. We offer personalized inspection readiness programs, remediation services, Qualified Persons services, and so much more. Come see us at Booth #1226 to learn about our full suite of services. Whether you are at DIA or not, if you are looking to grow your compliance expertise's as a client or consultant, fill out our contact form here. Our team will be in touch! https://hubs.ly/Q02CdCcp0 #DIA2024 #conference #exhibithall #regulatorycompliance #chartingnewhorizons #qualityassurance #GXP #GCP #GMP #GLP
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