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Ensuring compliance in temperature mapping isn’t just about the technology—it’s about meticulous documentation. 📝 Every step, from equipment calibration to data logging, must be recorded accurately. Regulatory authorities expect proof of consistency and reliability in your storage environments. Remember: Document, document, document. Initial and date everything to maintain a clear audit trail. This diligence not only meets compliance standards but also strengthens the integrity of your operations. Stay prepared, stay compliant. #TemperatureMapping #Compliance #Documentation #GMP #GLP #Pharmaceuticals #QualityAssurance

We tuned into the FDA's webinar yesterday regarding the final rule on #LDTs - slides for reference below if you missed it! A couple observations from the pre-submitted questions: • Still a lot of confusion around which tests fall under the new guidelines, made more complex by the variety of discretion policies • FDA admits these rules disproportionately affect smaller labs We'll be paying attention to future developments on this ruling! #fda #regulatory #laboratorydevelopedtests #lifesciences #pharma #drugdevelopment #medicaldevices #meddevices #biotech #quality #qualitymanagement #regulatoryintelligence

Failure to identify and address issues represents the biggest threat to success in achieving regulatory approval. Our team can help you identify those issues and face them head-on. We address issues as a crucial aspect of developing an effective communication strategy and generating compelling messages, whether for an AdComm, regulatory submission, FDA meeting, or other critical communication. Check out our BOLDAPPROVED newsletter to learn more! Get help with your issues. Contact us at boldapprovals.com, info@boldapprovals.com, or +1 (646) 930-0453. #YouveGotIssues #IssueManagement #CommunicationStrategy #Messaging #FDAprep #AdComms #FDAsubmissions #NDA #BLA #FDAmeetings #BeBoldsci #BeBOLD #BOLDAPPROVALS #BOLDSCIENCE #MedComms #Pharma #Biotech #RegulatoryAffairs #RegulatoryCommunication

Join us on a journey through time, as we delve into the critical shift in the pharmaceutical industry towards data security and integrity, and our pioneering role in the history of 21 CFR Part 11 implementation with our latest Blog Post: "Kaye's Time Warp: Kaye and 21 CFR Part 11". Uncover how an era heavily dependent on paper documentation witnessed a digital revolution with measures such as the FDA's 21 CFR Part 11 regulation, and how Kaye swiftly responded with the launch of Kaye Validator 2000 - the first validation system that met these regulations while also simplifying the entire validation process. Let's reminisce about our technological journey and the continuous innovation in the Kaye product range. Ready for the trip? Tap here to dive in: https://lnkd.in/eEDiWks6   #Kaye #DataSecurity #DataIntegrity #21CFRPart11 #PharmaceuticalIndustry #DigitalRevolution #InnovationsInPharma #KayeValidator2000 #Pharma #Biotech #Biotechnology

🚀 Exciting Update from the FDA! 🚀How do you think this will impact the industry? Let's discuss! 💬 The FDA has released the final guidance for industry: “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This finalizes the draft guidance published on October 30, 2019. It outlines the required electronic format for submitting IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as mandated under 21 CFR 312.32(c)(1)(i). These electronic format requirements are established under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)). 💡 Your thoughts and comments are welcome! How do you think this will impact the industry? Let's discuss! 💬 #FDA #Guidance #Regulatory #HealthcareInnovation #IndustryNews #pharmaceuticals #biotechnology #biotech

FDA Finalizes Drug and Biological Product Amount Reporting Guidance and Announces Portal Downtime Today, FDA issued the final guidance for industry: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act. The agency revised and finalized the guidance after considering comments to the draft. The revisions include: Updating the recommended time frame for submitting 2023 calendar year reports to be no later than July 31, 2024, with reports for subsequent years recommended to be submitted no later than March 31 of the following calendar year. Providing recommendations for how to report on drug products in finished package form, drug products not in finished package form, and active pharmaceutical ingredients. Clarifying reporting requirements for registrants across the drug supply chain, including contract manufacturers. Clarifying how FDA plans to use data from the reporting program. Implementation of this final guidance will be delayed until February 26, 2024, to allow for the transition of technical updates to the CARES Act Amount Information Reporting application in the NextGen Portal. On February 26, 2024, FDA will deploy an updated version of the CARES Act Amount Information Reporting application in the NextGen Portal to be consistent with the recommendations in the final guidance. The October 2021 draft guidance will remain available until the updated application is available. Registrants of drug establishments (or their authorized agents) submitting reports should be aware of the following: Until February 22, 2024, continue to submit reports using the current version of the CARES Act Amount Information Reporting application. To accommodate the changes made between the draft and final guidance, the format for submissions will change when the updated version of the application launches. Submissions made using the current format will not work in the updated version of the application. Therefore, all submissions using the current format need to be submitted by no later than February 22, 2024, and all draft reports not submitted by February 22 should be deleted. From February 23-25, 2024, reports cannot be submitted while FDA is updating the CARES Act Amount Information Reporting application in the NextGen Portal. On February 26, 2024, the updated version of the application will launch with updated submission formats. FDA will issue a revised “Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide” on February 26, 2024, to assist registrants in submitting reports using the updated application and submission formats. With this FDA is better informed and able to take more targeted and timely actions to promote stronger supply chains and reduce drug shortage risks.

Join us for our next regulatory webinar as Antony Kaprielian dives into FDA eCTD Submissions live on September, 24 starting at 1:00 p.m. EDT. Register for free today at: https://ow.ly/QUYQ30sGBZz Did you know that making an electronic common technical document (eCTD)-compliant submission to the FDA requires complex coordination of stakeholders and a detailed culmination of product information? Providing all the necessary information to FDA will optimize the submission package for ease of review and make the entire process run smoothly. Find out how our experts can help! #Regulatory #Regulatoryaffairs #clinicaldevelopment #FDA #pharma #Biotech #lifesciences #drugdevelopment

Is your company's compliance costing you more than it should? Let's explore cost-effective strategies together. https://lnkd.in/eW7Aujwe #pharma #medtech #quality #gmp #compliance #regulatory 'zamann

January 18, 2024 Webinar: A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs for Regulatory Affairs candidates this webinar is really helpful if you want the webinar slides and recordings just comment and i will send them to you for free. ده كان مهم و مفيد جدا لو حد حابب ابعتله الماتريال بتاعته يكتبلي في الكومنتس webinarلكل اللي بيشتغل تسجيل ال #webinars #fda #course #workshop #career #careerdevelopment #regulatoryaffairs

THE MOST COMMON CAUSES FOR FDA WARNING LETERS ARE: • Absence of Quality Unit control and oversight. • Non-compliant written procedures. • Failure to follow written procedures. • Failure to prove that regulations have been followed with adequate documentation. Need us? Our experts are there for you. https://lnkd.in/d3n5dgeq #pharma #biotech #qualityassurance #consultants