QLeaR Advisors

🤓 QLeaR CEO & Principal Advisor Jackie Torfin looks forward to being an expert panelist at next month's Medical Device Innovation Consortium (MDIC) Excellence in Quality Workshop. Being held at the Edwards Lifesciences Corporate Campus in Irvine, CA, ☀️ it's sure to be a fantastic learning and networking event! Scroll for more info ... 💬 "MDIC Excellence in Quality Workshops are a unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across your total product lifecycle. Participants will be guided by industry experts and thought leaders through examinations of enterprise transformation, enhanced patient safety, and increased returns—all through the lens of the most advanced approaches to elevating quality." Event link https://lnkd.in/exFNMmdr #QLeaRadvisors #QLeaRcares #mlv #TalkToMeTuesday #MDIC #cali #quality #regulatory #FDAcompliance #CAPA #MakeCAPAcool #panelist #expert #MedicalDevices #FDA

💖 Establishing QLeaR #boundaries between your work and personal life is essential to prevent #burnout and maintain mental QLaRity. In today’s fast-paced world, where work can easily extend into personal time, it is essential to draw a firm line between #professional obligations and individual well-being.   💡A key step is to designate specific work hours and adhere to them. By setting a fixed schedule, you create a #structure that allows you to focus entirely during work hours while also ensuring that personal time is protected. Resist the temptation to check emails or respond to work-related tasks outside of these designated hours. Doing so can blur the boundaries and lead to increased #stress and exhaustion. #QLeaRadvisors #QLeaRcares #mlv #QLeaRMindMonday #MondayMotivation #wellbeing #StressReduction #calm #relax #balance

✨ Last week's MD&M Minneapolis event at the Minneapolis Convention Center proved to be very valuable and a wonderful chance for QLeaR CEO Jackie Torfin to meet up with some old team members! It was an energizing day, and she was able to speak on the QMSR and make valuable connections with old colleagues and current clients. 🤝 Link for NEXT YEAR's MD&M Minneapolis event 👉 https://lnkd.in/e8M5tGbF #QLeaRadvisors #QLeaRcares #mlv #MDM2024 #MDMMinneapolis #colleagues #MedicalDevices #MedDevice #Minneapolis

🤓 EVENT REMINDER: Next Tuesday, Our CEO and Principal Advisor, Jackie Torfin, will present with Karen Peifer, Principal Quality System Software Engineer at Silk Road Medical, Inc., and Paul Sumner, Program Director, Case for Quality, with Medical Device Innovation Consortium (MDIC). This educational event is in partnership with Minnesota Section - ASQ at the Plymouth campus of St. Cloud State University! Scroll for more info!... Event link ➡️ https://lnkd.in/gNDHX25f 💬 "CAPA Cool: A Risk-Based Approach: Are you interested in closing Corrective and Preventive Actions (CAPAs) in less time, leaving more time to focus on improvements and problem-solving? A risk-focused CAPA framework will transform the way you think. Stop the insanity of a traditional resource-draining one-size-fits-all CAPA method." 💬 "Championing a Culture of Quality: Continuous improvement leads to higher-quality devices, greater organizational efficiencies, and investment returns. Hear from quality leaders on the importance and challenges of elevating organization culture to one of Quality excellence from a variety of perspectives. The discussion will explore various challenges facing professionals and companies that directly impact elevating quality culture to the next level offering personal insights with successful best practices." #QLeaRadvisors #QLeaRcares #mlv #scsu #capa #asqmn #mdic #QualityCulture #MakeCAPAcool #regulatory #FDA #FDAcompliance #leadership #experts

🤔 Myth: The FDA approves Cosmetics. 🌟 Truth: The Federal Food, Drug, and Cosmetic Act gives the FDA authority to regulate cosmetics, but this regulation focuses primarily on labeling accuracy and preventing the use of harmful ingredients.   💄There is a common misconception that the FDA (Food and Drug Administration) approves #cosmetics before they are sold on the market. However, the FDA does not pre-approve cosmetics or their ingredients, except for color additives. 👉 Under U.S. law, it is the responsibility of cosmetic companies and manufacturers to ensure that their products are #safe for consumers before they are marketed. The FDA only steps in when there is evidence of a violation, such as unsafe ingredients or misleading claims.   💄Unlike drugs and medical devices, cosmetics do not need to go through an approval process before they are sold. As a result, companies can release products without formal safety evaluation by the FDA, relying instead on internal testing and #quality control.   💡 The FDA’s role in cosmetics regulation primarily focuses on ensuring that cosmetics are safe for consumers and properly labeled. #Manufacturers and companies are legally responsible for ensuring that their products are safe for use under labeled or customary conditions. The FDA can take action against a cosmetic product only if it is misbranded (labeling violations) or adulterated (contaminated or harmful).   💄While the FDA monitors cosmetic products already on the market and can act against adulterated or #misbranded products, it does not conduct routine safety assessments for cosmetics.    🌟 Consumers should be aware of this distinction and ensure they choose products from companies that follow safety #standards and avoid potentially harmful substances. The burden of safety largely falls on the manufacturers. This lack of pre-approval means consumers must be vigilant and choose products from trustworthy brands. #QLeaRadvisors #QLeaRcares #TruthOrMyth #WisdomWednesday #mlv #FDAcompliance #ConsumerSafety #FDA #regulatory #compliance #makeup #product #skincare #cosmetic

⚕️ The FDA is holding a very timely and informative webinar next week. We'd recommend saving a spot. Scroll for more info ... Info & registration link here ➡️ https://lnkd.in/gfPpZqCk #QLeaRadvisors #QLeaRcares #mlv #fda #FDAwebinar #pharma #CDER #cannabis #DDI #PatientSafety #MedicalMarijuana #CDERlearn

💖 Mindfulness #meditation is a powerful practice that can help train your mind to stay #focused on the present moment and let go of distractions. To begin practicing mindfulness meditation, find a quiet and comfortable space to sit or lie down without being disturbed. Close your eyes and take a few deep breaths to center yourself and bring your #awareness to the present moment. 🧘♀️ As you continue to breathe, focus on the sensations of your breath as it enters and leaves your body. Notice the rise and fall of your chest or the feeling of air passing through your nostrils. If your #mind starts to wander, gently bring your attention back to your breath without judgment. 💖 It's normal for #distractions to arise during meditation, such as thoughts, feelings, or physical sensations. Instead of getting caught up in these distractions, acknowledge them and then let them go by returning your #focus to your breath. Observing your thoughts and emotions without attachment can help you cultivate a sense of inner #peace and QLaRity. 🧘♂️ Consistency is key when practicing #mindfulness meditation. Start with short sessions, such as 5-10 minutes daily, and gradually increase the duration as you become more comfortable with the practice. Over time, you may notice improvements in your ability to stay #focused, manage stress, and cultivate a greater sense of #awareness and presence in your daily life. 💖 By incorporating mindfulness meditation into your #routine, you can train your mind to stay grounded in the present moment, reduce distractions, and cultivate a more profound sense of inner #calm and QLaRity. #QLeaRadvisors #QLeaRcares #mlv #QLeaRMindMonday #QLaRity #MondayMotivation #breathe #BePresent #health #MentalHealth

😃 Jackie attended the Society of Clinical Research Associates (SOCRA) 33rd Annual Conference from September 27 to 29th. One of the highlights was understanding some of the unique differences in running decentralized clinical trials utilizing #telemedicine. Telemedicine is used for many things, and each application can be different. One application is to screen and recruit participants from a wider 🌎 geographic area to enable a faster enrollment.  Researchers can also use telemedicine to educate participants at home using sensors, ⌚ wearables, or other technology.  Telemedicine for assessments and interventions Researchers can use telemedicine to conduct 📓 assessments or interventions with participants.  Researchers can use telemedicine to monitor participants in real-time and collect data directly or to conduct virtual study visits with them, where they can take vital signs, review 💊 medications, or administer questionnaires. 👉 The time is now to understand how nuanced the regulations in each state are regarding informed consent, the practice of medicine, and the use of a principal investigator. You don't want to be left behind. More info on the conference that happened right here https://lnkd.in/gJFdsTf7 #QLeaRadvisors #QLeaRcares #mlv #SOCRA #FDA #FDAcompliance #ClinicalResearch #compliance #regulatory #quality #MedTech

🎃 Jackie Torfin's blog articles are always a great read! Check out her October article ... Click here 🦇 https://lnkd.in/gDU6AjFZ #QLeaRadvisors #QLeaRcares #mlv #MedicalDevices #MedDevice #QualityAssurance #QA #quality #regulatory #FDA #FDAcompliance #october #SpookySeason #blog

So excited to be speaking today at the MD&M Conference with the Minnesota Section - ASQ. I appreciate being able to share my knowledge on the upcoming QMSR changes. #QMSR #FDA #ISO13485 #QLeaRAdvisors #MD&M #MNASQ