𝗛𝗲𝗿𝗲'𝘀 𝗺𝘆 𝟳-𝘀𝘁𝗲𝗽 𝗽𝗹𝗮𝘆𝗯𝗼𝗼𝗸 𝗳𝗼𝗿 𝗲𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝘀𝗺𝗼𝗼𝘁𝗵 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝘁𝗵𝗮𝘁 𝗜'𝘃𝗲 𝗿𝗲𝗳𝗶𝗻𝗲𝗱 𝗼𝘃𝗲𝗿 𝘆𝗲𝗮𝗿𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝗽𝗮𝗰𝗲: 𝟭. 𝗦𝘁𝗮𝗿𝘁 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗲𝗻𝗱 𝗶𝗻 𝗺𝗶𝗻𝗱 - 𝟭𝟴-𝟮𝟰 𝗺𝗼𝗻𝘁𝗵𝘀 𝗯𝗲𝗳𝗼𝗿𝗲 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 • Map your regulatory strategy to your commercial goals • Identify your regulatory pathway early (510(k), De Novo, PMA) • Build testing protocols based on predicate devices when applicable 𝟮. 𝗗𝗲𝘀𝗶𝗴𝗻 𝘆𝗼𝘂𝗿 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺 𝗳𝗼𝗿 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 • Implement ISO 13485 principles from day one • Focus on the 7 critical SOPs that impact submissions most • Avoid the common trap of documentation overload (I've seen startups with 200+ SOPs when 35-40 would suffice) 𝟯. 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗲 𝘆𝗼𝘂𝗿 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗺𝗲𝘁𝗵𝗼𝗱𝗼𝗹𝗼𝗴𝘆 𝗯𝗲𝗳𝗼𝗿𝗲 𝗲𝘅𝗲𝗰𝘂𝘁𝗶𝗻𝗴 • Pre-validate test methods with 3-5 pilot runs • Engage with testing labs that have FDA submission experience • Document protocol deviations properly (we found 63% of submissions get delayed due to inadequate deviation management) 𝟰. 𝗟𝗲𝘃𝗲𝗿𝗮𝗴𝗲 𝗽𝗿𝗲-𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗺𝗲𝗲𝘁𝗶𝗻𝗴𝘀 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰𝗮𝗹𝗹𝘆 • Schedule Q-Sub meetings 9-12 months before planned submission • Prepare focused questions (limit to a few critical issues) • Follow up with written summaries within the allocated time 𝟱. 𝗕𝘂𝗶𝗹𝗱 𝗮 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 "𝘄𝗮𝗿 𝗿𝗼𝗼𝗺" • Assemble cross-functional team (R&D, Clinical, Quality, Regulatory) • Create submission trackers with accountability metrics • Hold twice-weekly stand-ups in the 90 days before submission 𝟲. 𝗖𝗼𝗻𝗱𝘂𝗰𝘁 𝘁𝗵𝗶𝗿𝗱-𝗽𝗮𝗿𝘁𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗿𝗲𝘃𝗶𝗲𝘄 • Have external experts review 100% of your technical documentation • Use submission management platforms like RADAR or MasterControl • Schedule review 45-60 days before planned submission date 𝟳. 𝗣𝗿𝗲𝗽𝗮𝗿𝗲 𝗳𝗼𝗿 𝗶𝗻𝘁𝗲𝗿𝗮𝗰𝘁𝗶𝘃𝗲 𝗿𝗲𝘃𝗶𝗲𝘄 • Anticipate FDA questions with "pre-mortem" analysis • Have subject matter experts on standby during review period • Create response templates for common deficiency categories I learned these lessons the hard way. Early in my career I worked at a company where we had three submissions rejected due to inconsistent test data formatting. Now we use standardized data presentation templates that have cut our Additional Information requests by 72%. 𝗧𝗔𝗞𝗘𝗔𝗪𝗔𝗬: Regulatory success is about methodical preparation and strategic execution. The companies that view regulatory as a strategic function rather than a compliance burden consistently outperform their peers in time-to-market by an average of 7 months If you're preparing for an FDA submission in the next 12-18 months, I'd be happy to share our pre-submission checklist. Just message me directly
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🚨 USDA Just Dropped 4 Major FY2025 Grant Programs — Over $100M in Funding Now Open The USDA’s Agricultural Marketing Service just opened four major grant programs designed to rebuild local food systems, expand supply chains, and strengthen market access for producers, food hubs, and community partners. These are highly competitive and politically sensitive—apply with intention. 🧺 Farmers Market Promotion Program (FMPP) $11M available | $50K–$500K awards Deadline: June 27 Supports direct-to-consumer sales (farmers markets, CSAs, agritourism, online platforms) Use of funds: tech upgrades, food safety certifications, marketing, on-farm food waste reduction, value-added production 🛒 Local Food Promotion Program (LFPP) $11M available | $25K–$500K awards Deadline: June 27 Focuses on intermediaries (aggregators, distributors, processors) in local/regional food chains Use of funds: feasibility studies, infrastructure, cold storage, transportation, business development, labor and training 🌱 Regional Food System Partnerships (RFSP) $4.5M available | $100K–$1M awards Deadline: June 27 Funds regional coalitions working to coordinate food systems and align cross-sector efforts Use of funds: partnership building, systems planning, shared measurement, outreach, infrastructure coordination 🍓 Specialty Crop Block Grant Program (SCBGP) $72.9M available | State-administered, check with your state ag agency Deadline: July 7 Supports fruits, vegetables, tree nuts, floriculture, and other specialty crops Use of funds: market expansion, technical assistance, research, environmental mitigation, access for underserved producers Note: Language and framing matter more than ever. Under the current political climate, terms like “equity,” “community-led,” and “justice” are being quietly removed from review guidance. Fund the same work—just use strategic, outcomes-based language. If you work with farms, food hubs, cooperatives, tribal producers, or rural coalitions, now is the time to align. These deadlines won’t move. Share this with your development teams, coalitions, or partners. Drop questions in the comments or DM me if you’re writing or advising on an application. #USDA #Grants #FoodSystems #LocalFood #FarmersMarkets #RegionalDevelopment #Nonprofits #EquityInPractice #GrantStrategy #FundingOpportunities #CommunityWealth #PublicPolicy #GrantWriting
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Early in my career, I made two classic mistakes: 1. Rushed papers to meet deadlines 2. Delayed them chasing perfection Neither approach worked. It took me years to learn how to balance quality & speed—without sacrificing either. Here’s 4-step game-chaging framework: --- 1. Planning & Prioritization • Break your project into milestones • Block time for writing • Start with high-impact sections 2. Efficient Research Process • Use Zotero or EndNote • Stick to reputable databases • Take detailed notes to avoid duplication 3. Streamlined Writing Workflow ✍️ • Don’t over-edit mid-draft • Use journal templates • Write in focused sprints 4. Quality Assurance Before Submission ✅ • Edit in multiple rounds • Run grammar & plagiarism checks • Get unbiased feedback from peers --- Don’ts ❌ • Skip proofreading to save time • Overload with unnecessary data or jargon • Delay starting until all data is perfect • Ignore journal guidelines in rush to submit --- Key takeaway 📌 Consistency beats speed alone. O Structure beats perfectionism. — Follow me 👉 https://lnkd.in/d4b-t6b3 Read The Hybrid Researcher 👉 https://lnkd.in/dMB8YJgm Connect with me 👉 https://tr.ee/yEg4hY
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Integrating Aconex Deliverables with MIDP to Track Submission Progress to Cut-Off On complex programs, aligning Aconex document control workflows with the Master Information Delivery Plan (MIDP) is essential to maintain visibility, accountability, and timing of deliverables. Here’s a structured integration workflow we’ve used to link Aconex submissions with MIDP ‘Date Required’ for real-time tracking: 1. Standardize Document Codes Apply ISO 19650 naming across both Aconex and MIDP. The Document Code becomes your single source of truth. 2. Structure the MIDP Include: • Document Code • Discipline / Package • Date Required • Responsible Party • Planned vs Actual status 3. Ensure Metadata Quality in Aconex Every document upload must include: • Document Code • Submission Date (auto-logged) • Status (e.g., For Review, Approved) • Discipline / Package • Optional: Custom field for “Date Required” 4. Export Aconex Register Filter by work package or discipline and export the document register (CSV/Excel). 5. Link MIDP & Aconex in Excel or Power BI Use XLOOKUP or data relationships to merge the two datasets via Document Code. Compare: • Date Required (MIDP) vs. Actual Submission Date (Aconex) 6. Filter by Cut-Off Date Track which documents were: • Due before the cut-off • Submitted late or not at all • Rejected or pending 7. Automate Tracking Dashboards Power BI dashboards visualize: • % Submitted On-Time • Discipline-wise status • Trends in submission vs delay This workflow turns disconnected platforms into an integrated delivery engine anchored in data-driven decisions, ISO 19650 alignment, and real-time compliance monitoring. Have you linked MIDP with your CDE before? Would love to hear your approach. #DigitalDelivery #Aconex #MIDP #BIMManagement #ISO19650 #ProjectControls #BIMInPractice #ConstructionTech #DesignCoordination
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Medical insurance Claim Filling Time Limit Chart US( Based Payers) --> Key Notes & Best Practices 1. Start date matters: Timely filing begins from date of service, or for extended services, from the last date of service. For COB (coordination of benefits), some payers begin the clock after the primary payer’s EOB . 2. Plan-level variations: Timely filing can differ by plan type (e.g., Medicare Advantage vs commercial), provider participation status, and even by geographic region. 3. State programs differ: Medicaid deadlines range state-to-state. For example, Medi-Cal (CA) allows 180 days; Texas Medicaid 95 days; NY Medicaid 90 days. 4. Denied & corrected claims: These may require submission within a shorter window (e.g., 60–90 days from denial) . 5. Federal program exceptions: Medicare and Tricare fill a full year. Worker’s comp, Ambetter, and BCBS plans can stretch beyond 365 days. --> Why Missing Timely Filing Hurts Claims submitted after the deadline are typically flat-denied (e.g., CO‑29: "timely filing limit exceeded"). Even appeals are often disallowed if the original claim is late. ✅ Tips to Prevent Denials - Internal workflows: Submit initial claims within 30–45 days, allowing buffer before deadline. - Automate alerts: Use revenue cycle tools to flag approaching deadlines. - Provider manual reference: Always verify each payer's manual/contract regularly. - Track denials: Use timely filing denial codes to re-file before absolute limit, if allowed. Here’s a refined and updated chart of timely filing limits for major U.S. payers (as of mid-2025). These are general guidelines—always check plan specifics:
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By this stage, you have drafted your documents and met almost all the requirements. Now comes the “final stretch” to actually submitting your applications. Week Eight: Steps to submitting your application This phase involves presenting a complete, polished, and timely package that demonstrates strong evidence of months of preparation. Here is what you should expect and do: 1. Research and confirm requirements - Visit each program’s admissions page - Verify the scholarship and admissions deadlines (be aware that they may vary) - Check required documents, including test results, recommendation letters, transcripts, SOPs, and CV - Confirm the word limits and other extra instructions (like additional essays). Don’t assume; always verify - Check if standardized tests are required - Update your application tracker and use color-coding to flag urgent tasks 2. Sending Standardized Test Scores If these scores are required, please send them directly through ETS or the testing portals well in advance of the deadlines. You usually have four free reports on test day—plan which schools to send them to in advance (see more details in week six). 3. Complete the Application Portal Applications usually require you to: - Fill in basic biographical information, including academic background and professional experience - Upload your CV, SOP, transcripts, and any other needed documents - Save each file in PDF format unless otherwise requested. Use professional file names like Firstname_Lastname_SOP.pdf - Submit additional essays and confirm you have answered every required question - Avoid last-minute rushes and incomplete answers 4. Remind your recommenders to submit their letters - Follow up politely with referees a few weeks before deadlines to confirm submission - Remember, your application is not complete until all recommenders submit - Add referee details early in the portal to trigger automated emails - It is good practice to waive your right to see the letters when asked - Remind referees well ahead of the deadline - Check week 3 on "How to get strong recommendation letters" for more details 5. Submit early and pay application fees (or use waivers) - Prepare to pay application fees. Confirm whether you qualify for a fee waiver before paying (see Week two for details on applying for waivers) - Application portals can crash or slow down on the deadline day, so avoid submitting that day - Plan to submit at least a week in advance, and take time zone differences into consideration - Save confirmation emails and receipts in a folder. Update your application tracker to “Submitted.” A well-planned submission will reduce anxiety and increase your chances of success. Stay calm, stay organized, and have faith in the effort you have already made. See you next week! #JenniferScholarshipSeries | 8 of 10
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How We Stopped Missing Agile Release Deadlines – with One Simple Technique - last week I promised to explain - its really simple ... Story behind - A team had been working on a major release for over a year—sprint after sprint, trying to deliver. But when the deadline approached, frustration hit hard. Stakeholders expected more than what was possible, and despite all efforts, the team was running out of time. Instead of pushing harder without direction, we visualized the problem—by tracking buffer consumption with a fever curve - see the pictures of many agile releases in the carousel! Here’s how it works: ✅ Dimensioning the buffer – We estimate the total work, account for uncertainty, and allocate about one-third of the expected effort as a buffer. ✅ Tracking progress – The fever curve compares work completed (burn-down X-axis) against buffer consumption (Y-axis). If work progresses faster than buffer usage, the project is green. If the buffer disappears too quickly, yellow or red signals indicate risk. ✅ Fixing issues before they escalate – typically, you see early that progress wasn’t keeping up. The root cause? A bottleneck team was overloaded. By reallocating resources to support them, the entire project regained flow. But there are many other root causes possible - this is just a typical example! The result? Instead of missing another deadline, the team delivered earlier than planned. This approach works in small teams and massive programs alike—even in a 10,000 person-day project with 400 people across 24 workstreams, the fever curve helped keep everything on track. No more guessing. No more last-minute panic. Just clear visibility, smart adjustments, and reliable delivery. How does your team track delivery risk? Let’s discuss. p.s.: not even 4 weeks ago I opened a community about hyper-productive teams ... already over 320 participants in the free area. Here you find a course about this Reliable-Scrum-Thing - so just join - there is much more to find: https://lnkd.in/eQR_AgmM
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Hi Everyone, Timely Filling Limit Timely filing denials can be a nightmare for medical billing professionals. But here's the truth: They're often avoidable. After 5 Years of verifying patient coverage, I've learned a few tricks: 1. Know your payers' deadlines. Create a spreadsheet with filing limits for each insurance. 2. Submit claims daily. No excuses. 3. Leverage your EHR. Most systems can generate reports showing claim submission dates. 4. Train your team. Everyone should understand the importance of timely filing. 5. Set up alerts. Use your practice management software to flag approaching deadlines. But what if you still get denied? Don't panic. Appeal smartly: • Gather proof of timely submission (EDI logs, correspondence) • Write a clear, concise appeal letter • Include all relevant documentation • Submit within the appeal deadline Remember: A denied claim isn't always a lost cause. With the right approach, you can often turn it around. What's your go-to strategy for avoiding timely filing denials? Share in the comments! ------ I recommend you to understand these differences. Results will be: reduced denials + smooth billing. Level up your RCM.! 👉Follow me for more updates: Shorya R 👍Like ✍Comment 🤝Share #winwithbestwishes #DenialManagement #ClaimResolution #RevenueCycleManagement #InsuranceClaims #HealthcareInsights #BillingMadeSimple #MedicalBilling #RevenueManagement #HealthcareAdmin
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Unlike many other fields in pharmacovigilance, such as ICSR management or clinical trials, aggregate safety reporting (ASR) often offers more manageable timelines. However, the challenge arises with those unexpected ad hoc requests- situations where time crunch becomes inevitable. Over time, I’ve developed some strategies to handle these tight deadlines without compromising on quality. 1️⃣ Prioritize and Adjust Timelines 👉 When faced with an ad hoc request, I evaluate all ongoing tasks and adjust the timelines of reports or deliverables that are later due. Regulators are often open to justified extensions for less critical submissions, allowing us to allocate resources where they're needed most. 👉 Clear communication with stakeholders about the reprioritization ensures transparency and avoids downstream delays. 2️⃣ Plan, Plan and Plan 👉 I break down the report into smaller deliverables and prioritize high-impact sections (e.g., safety concrens, case analysis, benefit-risk analysis). 👉 Not only for ad hoc reports, I always try to create a reverse timeline- starting from the submission date and mapping key milestones backward, accounting for dependencies like cross-functional reviews. 👉 Not to mention, I always allocate buffer time to keep enough room for any inevitable last-minute changes. 3️⃣ I Leverage Templates 👉 I always use standardized templates that save time on formatting and ensure consistency across reports. 4️⃣ The most important- Stay Calm Under Pressure 👉 When deadlines tighten, I remind myself to stay calm and focused. Rushing can lead to errors, so maintaining a steady approach is key. 👉 I believe it’s better to submit a complete and accurate report slightly later if needed (with proper justification) than a flawed one on time. Regulators consistently value quality over speed. A Recent Example- In one of my tightest timelines for a PSUR submission, reprioritizing timelines for another report allowed me to focus on the immediate deadline. By using automated functions in MS excel, I made the data extraction, seggregation of sections, easier. In turn, I freed up time for in-depth case analysis and safety discussions. Well, guess what! The submission was on time, and the feedback from client highlighted the clarity of the well authored safety sections including benefit-risk assessment! We all know that managing ad hoc deadlines is an art. Balancing speed while delivering quality takes experience, teamwork, and the right decision making. How do you tackle time crunches in aggregate report submissions? I’d love to hear your strategies! #Pharmacovigilance #AggregateReports #PSUR #DSUR #PADER #RiskManagement #DrugSafety #ProductivityTips #Pharmacist #LinkedInCommunity #LinkedIn