Karan Modi, MS RA, RAC

"🚨 Quality Over Correction: The FDA's Wake-Up Call in 2024 🚨 In 2024 alone, the FDA has issued a staggering 15 cease decrees, a testament to the urgent need for proactive quality assurance (QA). As professionals, especially from the east coast to all across the US, we're witnessing the pivotal role QA plays - not just as a fix-it tool but as a prevention powerhouse. The decrees are clear indicators that it's time to shift our focus. 🛑✋ 1) Integrating QA from the get-go is critical. Implementing robust quality controls at each production stage can be the difference between a product's success and a costly recall. Real-time monitoring and risk assessments are no longer optional; they're the lynchpins of trust in our industry. 2) Leveraging QA as a continual process, rather than a final checkpoint, transforms our mindset. It's about embedding a culture of excellence within teams. Embrace QA as the heart of operations, not the ambulance at the bottom of the cliff. 3) The statistics don't just urge, they scream for a change. With the right QA practices, not only do we safeguard consumer health, but we also bolster industry credibility and our own bottom lines. It's a win-win that calls for immediate action and commitment. Leaders, it's time we ask ourselves—is our QA proactive or merely reactive? 🤔 Join the movement towards a safer, more reliable future. Share your thoughts below. ⬇️ #QualityAssurance #FDACompliance #ProactiveChange"

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Who confirms if it is a Signal or an emerging safety concern/potential safety issue? What are the recommendations for actions?☺️☺️ Common interview question😇😇 - US FDA - FDA Posting (CDER+CBER from FAERS - Quarterly) - EU - PRAC (EudraVigilance - Monthly) Common mistakes made by MAH's partners - Affiliates and Service providers (CROs): - Closure of the safety concerns just by validating and without "confirmation". - Lack of documentation may lead to a Critical/Major audit finding. PRAC recommends actions after Signal assessment👇👇 #drugsafety #jobs #career #pharmacovigilance #bpharm #mpharm #MBBS #MD #BDS #BAMS #clinicaltrials #drugdevelopment #quality #fda #pharmaceuticalindustry #clinicalresearch #clinicaldevelopment #regulatoryaffairs #biotech #pharmaceuticalcompanies #pharmaindustry #medicalaffairs #pharma #biopharmaceuticals #vaccines #drugdiscovery #medicaldevice #pharmaceuticalsciences #lifesciences #signaldetection #aggregatereports #training #riskmanagementplan #RMP #medicine #medical #healthcare #medicaldevices #safety #onlinetraining #ICSR #PBRER #DSUR #PSUR #PADER #REMS #opportunities #interview #team

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With the transition to the FDA QMSR and ISO 13485:2016 requirements some medical device companies that are not currently following ISO 13485:2016 could require significant changes to their quality management system. We must be prepared to assume the changes that these new provisions presume. In 2026, the Medical Devices Market will have an important update in its Quality Systems. ☝️ #FDA #QMSR #ISO13485

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#customeraudit #teamwork #GMP #Auditee #gratitude🙏 An auditor is like a detective with a superpower for finding missing cents and hidden mistakes. They can sniff out discrepancies faster than a bloodhound on a scent. They’re the party guest who counts the number of chips in the bowl to ensure nobody’s sneaking extras. Their arch-nemesis is the elusive "non-conformity," and their mission is to bring order to the chaotic world of GMP & GDP. In their spare time, they dream of perfect documentation in the imperfect world.

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View all Official FDA Guidance Documents and other Regulatory Guidance: You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period: https://lnkd.in/eAfW-r53

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Move by Move: Life Lessons on and Off the Chessboard Book by Maurice Ashley At age thirty-three, Maurice Ashley became the first African American to attain the rank of International Grand Master of Chess. Since that historic moment, he has brought his love of the game to a wide audience as an educator, innovator, and motivational speaker. In Move by Move, Ashley guides readers through the essential lessons that chess has taught him about life, using both personal examples from his rise from an immigrant kid playing matches in Brooklyn parks to the most rarified levels of competition, as well as insights and anecdotes from fellow notable chess players. In short chapters with practical takeaways, this book reaches from the fundamental to the counterintuitive on subjects ranging from self-knowledge to strategic thinking to the importance of failure. This little book of wisdom is the perfect gift for graduates, chess enthusiasts, and anyone interested in understanding how lessons from the most famous and long-lasting game of strategy can help you reach your personal and professional goals. Chess is timeless. This book is perfect for anyone who plays chess, is chess-aspirational, or just has positive associations with the game. For the reader seeking a motivational book with actionable takeaways, Maurice Ashley offers the perfect authoritative yet accessible volume.

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How to deliver high quality periodic and aggregate reports within timelines?👇👇 Most MAHs, CROs and Consulting firms face challenges either with the:😊😊 - High quality delivery - Too many comments/suggestions on initial and subsequent draft reports by reviewers - QPPV/Medical directors. - Submission within timelines - Too many resources working on different sections of the same report due to high volume, with no idea on the scope, objective and goal of the report. The trick is to check previous reports, addressed comments and start drafting early as mentioned below😇😇 #drugsafety #jobs #career #pharmacovigilance #bpharm #mpharm #MBBS #MD #BDS #BAMS #clinicaltrials #drugdevelopment #quality #fda #pharmaceuticalindustry #clinicalresearch #clinicaldevelopment #regulatoryaffairs #biotech #pharmaceuticalcompanies #pharmaindustry #medicalaffairs #pharma #biopharmaceuticals #vaccines #drugdiscovery #medicaldevice #pharmaceuticalsciences #lifesciences #signaldetection #aggregatereports #training #riskmanagementplan #RMP #medicine #medical #healthcare #medicaldevices #safety #onlinetraining #ICSR #PBRER #DSUR #PSUR #PADER #REMS #opportunities #interview #team

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While the internet often celebrates risk-taking, we overlook the real weight it carries for each individual. Think about it: Someone supporting a family approaches risk very differently from someone who doesn't bear others' responsibilities. A parent wouldn't quit their job to chase a dream without considering their family's needs. Instead, they might opt for a safer job change to secure their children's future. Some people don't seek extreme wealth, but aim for having enough money to be able to spend more time with loved ones. I applaud every individual for taking risks - from risking unemployment to start a business, to switching a job, risking not liking the work environment.

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😧**Are ‘Assumptions’ Undermining Your Internal Audits?**😧 Here’s my thoughts on why removing those presuppositions can improve your QMS. P.S. this also works for everyday life! Deal with the facts, and the facts only! **Presupposition is an underlying assumption or belief made without explicit evidence** Presuppositions can often cloud our judgement, leading to biased outcomes. This is particularly critical in the context of internal auditing, where impartiality is key to ensuring the effectiveness of quality management systems. ISO 9001:2015 emphasises the need for an unbiased internal audit process. 🔍 **Why Avoiding Presuppositions Matters:** 1. **Unbiased Analysis:** Ensures that all findings are based on factual evidence rather than preconceived notions. 2. **Enhanced Credibility:** Builds trust in the audit process, promoting a culture of continuous improvement. 3. **Accurate Compliance Assessment:** Facilitates the identification of non-conformities and opportunities for improvement, ensuring that your organisation meets ISO 9001:2015 requirements. For internal auditors, approaching each audit with a fresh perspective is crucial. By doing so, they not only uphold the integrity of the audit process but also contribute to the overall enhancement of the quality management system. #InternalAudit #ISO90012015 #QualityManagement #ContinuousImprovement #Objectivity #Impartiality #BusinessExcellence

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Check out Shawn and Essenvia as excellent sources of information to help you on your quality compliance journey!

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The following processes are considered critical activities of pharmacovigilance👇👇 If missing in your QMS, will result in a sure shot "Critical" finding during audits: Solution: Implementing a process/procedure (at least an SOP or Work Instructions) will eliminate this issue😇😇. Save this for reference. Also, download "A Quick guide to ace PV audits" under featured! To summarize, the following must be in place for authorised medicinal products:😊😊 • ICSR collection, processing, management, quality control from any source • Continuous safety profile monitoring and benefit-risk evaluation • Risk management systems and effectiveness of risk minimisation measures • signal management • Periodic safety update reports: scheduling, preparation and submission • Responding to requests from competent authorities • Interaction between the pv and product quality defect systems • Communication about safety concerns between MAH and competent authorities, changes to the risk-benefit balance of medicinal products; • Communication to patients and healthcare professionals about changes to the risk benefit balance of products • Keeping product information up-to-date with the current scientific knowledge • Implementation of variations to marketing authorisations for safety reasons Business continuity plans should be established in a risk-based manner and should include: • Provisions for events that could severely impact on the organisation’s staff and infrastructure in general or on the structures and processes for pharmacovigilance in particular; and • Back-up systems for urgent exchange of information within an organisation, amongst organisations sharing pharmacovigilance tasks as well as between marketing authorisation holders and competent authorities. #drugsafety #jobs #career #pharmacovigilance #bpharm #mpharm #MBBS #MD #BDS #BAMS #clinicaltrials #drugdevelopment #quality #fda #pharmaceuticalindustry #clinicalresearch #clinicaldevelopment #regulatoryaffairs #biotech #pharmaceuticalcompanies #pharmaindustry #medicalaffairs #pharma #biopharmaceuticals #vaccines #drugdiscovery #medicaldevice #pharmaceuticalsciences #lifesciences #signaldetection #aggregatereports #training #riskmanagementplan #RMP #medicine #medical #healthcare #medicaldevices #safety #onlinetraining #ICSR #PBRER #DSUR #PSUR #PADER #REMS #opportunities #interview #team

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Future with more alignments among #regulations building up on each other as it did in the new #FDA QMSR and #ISO 13485 but still require independent individual inspections and certifications.

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PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT:: IND Safety Reports: April,2024 This guidance describes the electronic format sponsors will be required to use when they electronically submit to the Food and Drug Administration (FDA or Agency) investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this guidance under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). When the requirements of this guidance are in effect, this guidance will supersede the effective version of the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (eCTD guidance) as applicable to the electronic submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance (see section III., Scope of This Guidance). This guidance will not replace any requirements in the eCTD guidance other than those relating to the electronic submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance. This guidance also references several technical specification documents that provide additional details about the format for electronic submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS). This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted for IND safety reports that are required under 21 CFR 312.32(c)(1)(i) for serious and unexpected suspected adverse reactions. This guidance applies to IND safety reports that are submitted to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance changes the electronic submission requirements for this category of IND safety reports by requiring sponsors to submit the IND safety reports to FAERS in accordance with this guidance.

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I highly recommend you stop by the G&L booth and discuss with Nathalie. You will learn all about our regulatory and quality capabilities!!

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Trust is undoubtedly the most important factor for Any Relationship, be it Personal or Professional....

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The FDA has released the Quality Management System Regulation (QMSR) Final Rule for the Current Good Manufacturing Practice (CGMP). What does this mean in practical terms? 💡 In summary, the FDA has aligned its Quality System (QA) Requirement with the international consensus standard ISO 13485. The new name for this regulation is the Quality Management System Regulation (QMSR). Now there remain only few discrepancies to the ISO 13485. The additional requirements mainly concern: - Complaint records, device labelling and packaging - Consistency with other FDA requirements - Some adjustments to terminology For further info, look under: https://lnkd.in/dqdqHzyK

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Fiscal Year (FY) 2025 Notification of Annual BsUFA Fees: In preparation for FDA’s annual FY 2025 BsUFA invoices, the Notification of Annual BsUFA Fees correspondence was emailed to companies on June 7, 2024. Please submit your response by June 21, 2024. If you have any questions, please contact us at CDERCollections@fda.hhs.gov. If you intend to discontinue participation in the BPD program for FY 2025, you should follow the process outlined in the guidance for industry Assessing User Fees Under the Biosimilar User Fee Amendments of 2022. FDA must receive the request on or before August 1, 2024. If the request is received after August 1, 2024, you will receive an annual BPD invoice for FY 2025.  **Please note: This update is only applicable to companies that have products in the BPD program or user fee eligible biosimilar products in approved applications. ** The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (Bs UFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2022 through September 2027. FDA dedicates these fees to expediting the process for the review of biosimilar biological product applications, including post market safety activities. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public.

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If you are a regulator in NRA, take a moment to familiarize yourself with WHO GBT common terms. #regulatory #regulatorysystem #worldhealthorganization #nationalregulatoryauthority #nra #harmonization #benchmarking #gbt #pharmaceuticals

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