QLeaR Advisors

🤓 QLeaR Advisors CEO and Principal Advisor Jackie Torfin is excited to be presenting on June 30th at the 2024 Annual MWSQA Annual Meeting in Chicago! Her topics include: 1️⃣Use of FMEA as a Tool in GxP Investigations AND 2️⃣Five Plain and Simple Strategies to Develop Your Leadership Skills More info on the meeting here ➡ https://lnkd.in/gc5SHWwm #QLeaRadvisors #QLeaRcares #MLV #MWSQA #FMEA #FDA #FDAcompliance #IndustryEvent #compliance #regulatory #GMP #GCP #GLP #QMS #leadership #LeadershipSkills #quality

✒ Our CEO and Principal Advisor, Jackie Torfin, reflects on what she's learned so far in her career and shares helpful drivers of her success. Read more in her monthly blog... ➡ https://lnkd.in/gtXWZYcv #QLeaRadvisors #QLeaRcares #mlv #blog #quality #compliance #LadyBoss #QLaRity #HOQ #MedTech #leadership #Drucker

🎂I’m getting older… so what have I learned? It’s taken me WAY too long and a few bumps, bruises, diagnoses of myself and family members, but here we are. And guys, you have to learn for yourself, I think…but we’re going to get it out there anyway.    💖 Family and friends play an invaluable role in our lives, providing love, support, and a sense of #belonging. They are our pillars of strength during challenging times and our source of joy during happier moments. 💖 Taking time off to spend #quality moments with loved ones is essential for our overall well-being and mental health. It allows us to recharge, #rejuvenate, and find solace in the comfort of their presence. By nurturing these relationships, we cultivate a strong #support system that can help us navigate through life's ups and downs.   👉 Moreover, spending time with family and friends can positively impact our #work performance. 💖 Taking breaks to connect with our loved ones can help reduce stress, increase #motivation, and enhance #productivity. When we feel refreshed and supported, we are better equipped to tackle challenges, make sound decisions, and excel in our professional endeavors. 💖 Ultimately, prioritizing time with family and friends not only enriches our personal lives but also contributes to our success and #fulfillment in the workplace. 😊 So take this Wisdom – take the #vacation, take the weekends, take the evenings for yourselves and your families. YOU matter.  THEY matter. WE matter.  And we are doing this for the lives of the patients and we need to take care of each other first. #QLeaRadvisors #QLeaRcares #WisdomWednesday #wisdom #birthday #QLaRity #clarity #family #friends #yolo #mlv #wellbeing

Our CEO and Principal Advisor, Jackie Torfin, is excited to participate in this year's Medical Device Innovation Consortium (MDIC)’s #QualitySummit24 in Boston! One of the sessions she will be speaking in is “Championing a Culture of Quality" on Day One of the conference—event links and info below. Info & Registration Here ➡ https://lnkd.in/evwegQfP Event on LinkedIn ➡ https://lnkd.in/g_KBTAPv #QLeaRadvisors #QLeaRcares #MLV #QualitySummit24 #ThoughtLeader #MedTech #QualityAssurance #MedicalDevices #compliance #regulatory #quality #QualityCulture #FDA #FDAcompliance #MDIC

🌤 Happy Monday, all! Today and next week, we will combine a few tips for limiting information #overload and focusing your attention on essential tasks, which leads to more efficient outcomes. Reducing information overload also lets your mind #declutter and process information more effectively, resulting in improved cognitive function and mental #QLaRity. The human brain has finite #cognitive resources, and bombarding it with excessive information can lead to mental #fatigue, reduced productivity, and heightened #stress levels. Social media notifications, non-essential emails, and a continuous stream of online content contribute to perpetual distraction, making it challenging to #concentrate on essential tasks. Here are a few tips to ponder... 1️⃣Digital Detox: Allocate specific times for checking social media and emails. Designate periods where you #disconnect from the digital world, allowing your mind to reset and rejuvenate. 2️⃣Prioritize Essential Information: Identify and focus on information that truly matters. #Streamline your sources, unsubscribe from irrelevant newsletters, and curate your online content to prioritize quality over quantity. 💖 Two more to come next Monday. Have a wonderful work week! #QLeaRadvisors #QLeaRcares #QLeaRmindMonday #QLaRity #mentalclarity #MentalQLaRity #mlv #stressreduction #regulatory #compliance #wellbeing #advice #mindfulness #socialmedia #DigitalDetox

📚 It's time for another book recommendation! If you haven't yet had the chance, check out Carmine Gallo's "Talk Like TED: The 9 Public Speaking Secrets of the World's Top Minds." The New York Times best-seller was published in 2014, and it "provides insights from the world's top TED speakers, highlighting the qualities that make a great talk memorable and engaging." Read reviews & find a copy here 👉 https://lnkd.in/gdKGFCGA #QLeaRadvisors #QLeaRcares #mlv #BookRec #QLaRity #NYtimesBestSeller #TalkLikeTED #PublicSpeaking #PublicSpeakingTips #TEDtalks

Did you know it's All American Pet Photo Day?! 😀 We'd love to see yours! Check out Jackie Torfin's adorable pups, Meeka and Rudy. Both are Goldendoodles and are such a great part of the family. 🐾 Meeka is 11, super sweet, easygoing, and often is seen "rolling her eyes" at her younger brother. 🐾 Rudy is 5, energetic, and somewhat mischievous. There's rarely a sock he'll find that he doesn't like. He doesn't chew them ... he just carries them around. But throughout all of that, he still loves his cuddles. Tell us about your fur babies and spread the smile 😊 #QLeaRadvisors #QLeaRcares #AllAmericanPetPhotoDay #PetPhotoDay #pets #dogs #FurryFriends #smile #LoveYourPets

🤔 Myth: "FDA approval means a device is completely safe and effective." 💡 Reality: FDA approval or clearance indicates that a device meets specific safety and efficacy #standards but doesn't guarantee absolute safety. All medical devices have #risks, and ongoing monitoring is essential. ☑ FDA approval or clearance is a critical step in the #regulatory process for medical devices. It means that a device has met specific criteria established by the FDA to ensure it is reasonably #safe and effective for its intended use. ☑ Before receiving approval, a device must undergo rigorous #testing and clinical #trials to demonstrate its safety and effectiveness and show how the device performs, its potential risks, and benefits. ☑ Although FDA approval signifies that the device's benefits outweigh its known risks, it doesn't imply that it is entirely risk-free. Medical devices can have side effects, complications, or unforeseen issues that may only become apparent after widespread use. ☑ The FDA continues to monitor the safety and performance of medical devices once they are on the market. This includes collecting reports of adverse events, conducting #inspections, and taking action if safety concerns arise. ☑ Patients and #healthcare providers must also play a role in ensuring the safe use of medical devices. They should be aware of potential risks, follow proper usage instructions, report any adverse events to the FDA, and weigh the potential benefits and risks when considering a medical device. ☑ In addition, the FDA continually updates its #regulations and #guidance to adapt to new information and evolving #technology. This means a device's safety profile can change over time as more data becomes available. ☑ It's also worth noting that regulatory processes and standards for medical devices can vary from country to country. What may be considered safe and effective in one country might have a different status in another. #QLeaRadvisors #QLeaRcares #WisdomWednesday #TruthvsMyth #MLV #MedicalDevices #FDAapproval #FDA #ClinicalTrials #QLaRity #compliance

The FDA is hosting a webinar next Tuesday to discuss how it classifies in vitro diagnostic products (IVDs). Scroll for more info and the link to log in! More info here ➡ https://lnkd.in/geNbsRPN Link to log in (FDA requests you log in 15 minutes ahead of time): https://lnkd.in/dKmbqHPp Passcode: %KeTf9 #QLeaRadvisors #QLeaRcares #MLV #webinar #compliance #regulatory #MedicalDevices #CDRH #CDRHnews #FDA #TalkToMeTuesday

💖 With our QLeaR Mind Monday posts, we hope to start your week with a feeling of QLaRity and positivity. Why? Because #QLaRity breeds a sense of #purpose, enabling you to prioritize your #goals and create a weekly strategic #plan. 💖 With a QLeaR #vision of what needs to be accomplished, you can avoid feeling overwhelmed and ensure each task is tackled effectively. A QLeaR mind on a Monday sets the stage for a productive week. By decluttering your thoughts and focusing your attention, you'll be better equipped to tackle your work enthusiastically and efficiently. 💖 Embrace the potential of Mondays, and you'll find that they can be the foundation for a successful and fulfilling week ahead. #QLeaRadvisors #QLeaRcares #MLV #QLeaRmindMonday #MondayVibes #MondayMotivation #Positivity #Focus