Happening now: Lessons learnt from FDA inspection at S37. https://lnkd.in/giJG2xXs
Great interview Jonathan Cotliar!
LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Learn more in our Cookie Policy.
Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings.
Skip to main content
Happening now: Lessons learnt from FDA inspection at S37. https://lnkd.in/giJG2xXs
Life Sciences Tech Marketing Leader | Brand Strategist | Go-to-Market Expert | Revenue Growth Driver
6moGreat interview Jonathan Cotliar!
To view or add a comment, sign in
Ready to tackle FDA inspections? Our expert tips are here to help. Whether it's conducting mock inspections or ensuring all documentation is readily available, we've outlined the key steps for success. Explore our blog to learn more and prepare with confidence! https://lnkd.in/dCHwmwDK #FDACompliance #RegulatoryAffairs
To view or add a comment, sign in
Quality is never measured by the thickness of a paper stack.
Just a reminder that the fact that we create extra source and worksheets is bonkers in most cases. From FDA guidance: https://lnkd.in/gzjMG3vW #clinicaltrials #clinicalresearch
To view or add a comment, sign in
IMPORTANT: The FDA published its final ruling on LDTs, including several changes from its September 2023 guidance. Read our blog now for insights that will help you remain compliant: https://lnkd.in/g3iSvriP #CER #clinicalevalutations #clinicalresearch
To view or add a comment, sign in
Preparing for an FDA inspection is vital. Knowing the limits of the agency’s inspectional authority should be part of that preparation.
To view or add a comment, sign in
Streamline your US FDA registration with CDG's professional services. Ensure your products comply with FDA regulations for safe and successful market entry. #USFDARegistration #RegulatoryCompliance #cdginspectionlimited #qualityassurance #sustainability
To view or add a comment, sign in
Learn from Reviewers (FDA) - FDA mission and princlea to review products and practices (going back to initial goal and basic principles)
To view or add a comment, sign in
Next week! Join us live for our upcoming webinar on FDA LDT regulation. I'm excited to host this one with so many of the industry's brightest. When? Tuesday, April 23, 2024 at 09:00 AM PT Register Here https://lnkd.in/gpWUFpNG Share your questions below! #PrecisionMedicine
To view or add a comment, sign in
Almost every conversation I had at #AACR last week mentioned the looming FDA LDT regulation. Luckily, Megan Nacar is hosting a webinar with 6 policy, reg, and reimbursement leaders. Should be an insightful discussion!
VP of Commercial at DeciBio | I help precision medicine companies bring their innovations to patients, doctors, and scientists through strategy consulting, market intelligence, and venture | BLOC, HBA
Next week! Join us live for our upcoming webinar on FDA LDT regulation. I'm excited to host this one with so many of the industry's brightest. When? Tuesday, April 23, 2024 at 09:00 AM PT Register Here https://lnkd.in/gpWUFpNG Share your questions below! #PrecisionMedicine
To view or add a comment, sign in
The most interesting FDA report this year is out! Stay informed about the latest advancements and insights in the pharmaceutical industry. Check out the "FDA CDER Report on the State of the Pharmaceutical Quality 2023" for detailed information. ProQuality Network www.proqualitynet.com #PharmaInsights #FDAReport #ProQualityNetwork
The most interesting FDA report this year. ProQuality Network www.proqualitynet.com
To view or add a comment, sign in
This blog post is intended to be the first of several that will discuss the specific steps that labs can take to comply with the FDA LDT Rule. https://lnkd.in/ef_kdVup
To view or add a comment, sign in
VP, Head of Quality Assurance & Compliance and Regulatory @ Science 37
6moSorry to have missed it but am sure it was amazing…. Thank you for all you do Jonathan Cotliar !