RQM ’s Post

Medtech Quality Leaders -> How would it feel to reduce the number of corrective actions initiated per month by 30%? - What other work might you prioritize? - Who on your team would you be unburdening? - What opportunities might the lower CoQ present? Thanks to experts like Elaine, clients of RQM have the opportunity to actually answer these questions - not just ponder them as hypotheticals. If you'd like to learn how, my dm's are always open. Great work Elaine! Keep going!

Call that Quality? Really? Just had a couple of really interesting conversations at #OCTEastCoast. One with a Quality Manager from a small Pharma, the other with a CRO BD person. The QM said they'd "heard of RBQM" but wasn't actually doing anything on it. They thought their teams were handling risk using spreadsheets, but wasn't sure. They were sure that they "have lot's of spreadsheets". The CRO said that their Sponsor customers just aren't asking for RBQM so they won't offer it. It's amazing to me that we're still having these conversations. Without #RBQM and risk-based approaches, how do you demonstrate #quality in #clinicaltrials? How do you manage #risks effectively using spreadsheets? I would argue you can't. There is a much better way. Come and talk to us on Stand 64 and find out how.

Risk-Based Quality Management (RBQM) significantly enhances clinical trials by ensuring patient-centric approaches, improving data integrity, and meeting stringent regulatory requirements. It operationalizes trials for better efficiency and outcomes. If you haven't already embraced this revolution then isn't it abut time?

📢 Attention CROs! Ready to shake things up and leave traditional trial methods in the dust? 🌪️ Embrace Risk-Based Quality Management (RBQM) to future-proof your processes, gain a strategic edge, and stay ahead of the game! 🚀 Watch our video now and get ready to lead the charge with our latest blog: https://hubs.ly/Q02Dn_s20 #RBQM #CRO #ClinicalTrials

2024 Predictions: Beauty Industry Edition -MoCRA compliance dates will be pushed again -ISO 22716 certification will skyrocket in demand -Contract testing labs will be overwhelmed by last-second attempts to satisfy new FDA requirements -Talent shortage for experienced Quality & Compliance management -Increased pressure on brands to audit contract manufacturing partners -Increased pressure on contract manufacturers to rapidly improve their QMS What would you add to this list? Qualitas Executive Group consults with beauty brands and manufacturers of all shapes and sizes to mitigate risk, comply with new FDA requirements, and deliver consistently safe products to the public. Not sure what MoCRA means for your brand or facility? Book an appointment with me so we can dial in your systems. 🤘🏻 #quality #compliance #consulting #beautyindustry #cosmetics #FDA #MoCRA

It’s better to build a fence at the top of the cliff than a hospital at the bottom -Joseph Malins (1895) It can be expensive to build a strong Quality and Compliance Management System The alternative is worse Build your systems before you think you need them Because you need them from the start We help CPG brands and manufacturers build, deploy, audit, and manage Quality and Compliance Management Systems Not sure if yours is working how it should? Not sure what a Quality and Compliance Management System is? Qualitas Executive Group was built for you #quality #compliance #consulting #manufacturing #dietarysupplements #cosmetics #beautyindustry #FDA #qualitas

📚 Welcome to VALOR Spotlight on self-inspection,quality audits To access the complete article join our website: 📚Link in comment enroll now and follow us 💥 #valoregypt #SanitizationSolutions #valorspotlight #DailyTips #BestPractices #IndustryInsights #ProfessionalDevelopment #QualityAssurance #PharmaEducation #GMPStandards #GMPProfessional

After getting a #warning letter or impact from #enforcement action one can realize the mistake and at the same time want to overcome that situation. Few may not give up few may............... Have you heard about the phoenix? The phoenix is an immortal bird that cyclically regenerates or is otherwise born again.  The phoenix is a rare but powerful magical bird, able to burst into flames and be reborn from the ashes. You can take inspiration from this bird. Making mistakes may not be the end but can be the beginning of a new journey... Making mistakes is not the destination but it's part of the journey and leads to a very beautiful destination if learn the lesson and implement the learnings to correct those wrong pathways. Compliance Challenges seem to be very difficult to handle if you cannot see the deep impact of your every decision. Many times it may seem to be just impossible to solve. Sometimes timelines, sometimes errors, sometimes failure of training, sometimes funds, sometimes deliverables, some times other problems may create obstacles in the way of compliance. But we have to overcome those challenges to save the patient who is your customer. And you will win in the business. Do you agree with me? #cgmp #facilitydesign #pharmaindustry #ceos #founders #manufacturers #pharmaceuticalindustry #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset #ceoinsights #audits #auditor #compliancesolutions #calibrationservices #sops #procedures #cleaningservices #analytical #validation #laboratory #21cfrpart11, #dataintegrity, #documentation, #gdprcompliance; #traininganddevelopment ; #trainingneeds; #trainingtips; #ceoaction #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative #collegesanduniversities #pharmacycollege, #mpharm #bpharm #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #womeninscience #womeninleadership #womeninbusiness, #tedx, #tedxtalk #tedxspeaker #india, TED, TEDx, and Motivational Speeches, #usfda, #warningletter,

Ready or not, here the QMSR comes!! Tune in to DP Minutes for insights and valuable information to get ahead of this transition.

Hey everyone, Darren here with another DP Minute you don't want to miss. Today, we’re diving into Comment No. 75 from the QMSR Preamble discussions. The FDA received feedback that a one-year implementation timeline for the new QMSR wasn’t enough. They took these comments seriously and extended the effective date to two years, meaning you now have until February 2, 2026 to comply. That might sound like plenty of time, but there’s still a lot to get done, especially for small and mid-size firms, or firms who have only sold in the U.S. market. Don’t wait until the last minute! Watch the attached video for all the details. Have questions about how this affects your business, or need help preparing? Visit DPDConline.com or connect with us directly here on LinkedIn. Let’s keep the conversation going! #QMSR #ISO13485 #FDA #MedicalDevices #DPDConsulting #MedicalDeviceRegulatoryConsulting #QualityManagementSystem #QSRegulation #QARA #MedicalDeviceConsultation