Timothy Lamm’s Post

At #MedCon2024 the FDA is sharing some very helpful information on the latest updates, such as… After a thorough Compliance Program update completed with collaboration of the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA)… FDA inspections will no longer be schedule-based (formerly every 2 years) but now are Risk-Based. It wasn’t tenable to maintain the schedule-based model with the number of device companies. #FDA #regulatorycompliance

#Skyreg #FDA update #Inspection Many thanks for the FDA staff to publish this amazing draft guidance Staggered inspection types are communicated in side the document: Inside this document, you will find: This policy applies to all drug inspection programs including, but not limited to: 1-Preapproval Inspections (PAIs) and Prelicense Inspections (PLIs): 2- Postapproval Inspections (PoAIs):  3- Surveillance Inspections:  4- Follow-Up and Compliance Inspections:  5- Bioresearch Monitoring (BIMO) Inspections:

FDA issues draft guidance on Third Party Review Program for 510(k) submissions and Emergency Use Authorization (EUA) requests. The guidance outlines the agency's expectations for reviews by third-party organizations. It also provides updated recommendations on the 510(k) Third Party Review Program previously discussed in the 2020 final guidance. Stay up-to-date on regulatory changes and read the full draft guidance today. #FDA #510k #EUA #regulatoryaffairs

FDA published draft guidance outlining key aspects of the 510(k) Third Party Review Program and third-party review of Emergency Use Authorization (EUA) requests. Check out the draft guidance to learn more about the FDA recommendations and expectations. https://lnkd.in/gg2be3vF Visit our website to learn how MWA can help support your quality and regulatory needs: www.mwa-consulting.com #medicaldevices #fda #regulatory

Did you miss our executive roundtable webinar earlier today on 'Navigating the FDA's Laboratory Developed Tests Regulation?' Good news. - The recording and slides will be emailed to everyone who registered! - The presentation will be available on demand via our website - We are still taking questions! Just a few hours ahead of our discussion, the Office of Information and Regulatory Affairs (OIRA) updated their status 'Final Rule' with a concluded date of April 22, 2024; so we are anticipating this to be published any day now. Should we do a part two after it's published? If so, anyone else we should invite to the conversation? Link to the on demand resources + OIRA update in the comments. #Diagnostics #LabDevelopedTests #FDA

How you respond to FDA Form 483 inspection observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. Here are 5 best practices for you to take appropriate actions toward an optimal response. Susan Shockey from Clarkston Consulting provides guidance to optimize the outcome after receipt of FDA observations. #meddevice #medicaldevices #fdacompliance #qualityinspection https://bit.ly/3PMF7bR

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

Stay informed with ERGOMED's weekly regulatory updates! 📋 FDA has made a significant change in the format of #INDsafetyreporting. Effective April 1, 2024, the finalized FDA guidance mandates electronic submission of IND safety reports to FAERS. Sponsors must use either the Electronic Submission Gateway (ESG) or the Safety Reporting Portal (SRP). Read guidance document: https://lnkd.in/euMkeKx FDA will accept IND safety reports to FAERS voluntarily before the new requirements come into effect. If sponsors opt for FAERS submission, they should not submit these reports in eCTD format. Learn more:  https://lnkd.in/dK-vtQXA. As we move towards a 2-year transition period from eCTD to E2B data standard, ERGOMED reaffirms its commitment to regulatory compliance. With our expertise in regulatory affairs, we're well-positioned to assist you in navigating these changes seamlessly. Stay tuned for more updates from our regulatory affairs experts! #RegulatoryUpdates #FDA #INDSafetyReporting #ErgomedClinicalResearch #Compliance

FDA QMSR Key Highlight: #FDAQMSR #QualityManagementSystem #ManagementReview #AuditReport #FDAInspection #RegulatoryCompliance #MedicalDeviceManufacturing #FDARegulations #QualityAssurance #FDACompliance

Inadequate failure investigations continue to be a major GMP deficiency and consistently make the FDA’s top 5 list for adverse observations. The FDA conducts an average of 1,000 inspections each year. Of those inspections, approximately 20% result in warning letters. The average fine for a CAPA-related violation is $1.5 million. How CAPA’s are executed and managed is crucial to maintaining a compliant organization. This course highlights: The various regulations governing CAPAs How CAPAs are successfully initiated and managed How an effective failure investigation and root cause analysis is accomplished. The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and the process, and to the safety of patients and customers. Join Now!