Meet Gregg Sherman, Senior Director of Quality at Sequoia Biotech Consulting. With over 25 years of experience, Gregg leads our Quality and Compliance division, offering unique insights into organizational culture and team dynamics. He oversees the development and management of quality processes for our life science partners, ensuring phase-appropriate quality systems that align with organizational needs. Gregg and his team specialize in deviation and CAPA management, change management, document control, risk management, training, and quality audits. Their goal is to provide right-sized solutions that minimize compliance risks and address systemic deficiencies. Learn more about Gregg and his commitment to a culture of quality and compliance at Sequoia: https://bit.ly/4baZqan #ExpertInsight #Quality #Compliance #LifeSciences
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Director at Qualistery | Pharma Events Championing Quality & Operational Excellence in the Industry | Offering exclusive webinar speaking and sponsorship opportunities to GxP suppliers to enhance their brand and reach 🚀
📢𝐄𝐦𝐛𝐫𝐚𝐜𝐢𝐧𝐠 𝐔𝐧𝐜𝐞𝐫𝐭𝐚𝐢𝐧𝐭𝐲: 𝐓𝐮𝐫𝐧𝐢𝐧𝐠 𝐑𝐢𝐬𝐤𝐬 𝐢𝐧𝐭𝐨 𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐢𝐧 𝐑𝐢𝐬𝐤 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬🚀 🔔Risk analysis is an essential aspect of decision-making in various fields, including finance, project management, and healthcare. 💡While uncertainty is often perceived as a threat, it can also be viewed as an opportunity. Embracing uncertainty in the process of risk analysis allows organizations to gain valuable insights and make more informed decisions. 🔍𝐈𝐝𝐞𝐧𝐭𝐢𝐟𝐲𝐢𝐧𝐠 𝐇𝐢𝐝𝐝𝐞𝐧 𝐑𝐢𝐬𝐤𝐬: Uncertainty prompts us to explore different scenarios and consider factors that may have been overlooked. By embracing uncertainty, organizations can uncover hidden risks that may have a significant impact on their objectives. 💡𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐯𝐞 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: Uncertainty encourages creativity and innovation in developing risk mitigation strategies. Organizations that embrace uncertainty are more likely to come up with novel solutions that can give them a competitive advantage. 🔛 𝐅𝐥𝐞𝐱𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐀𝐝𝐚𝐩𝐭𝐚𝐛𝐢𝐥𝐢𝐭𝐲: Embracing uncertainty fosters a culture of flexibility and adaptability. Organizations that are comfortable with uncertainty are better equipped to respond to unexpected events and adjust their risk management strategies accordingly. 📈 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐀𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞: Embracing uncertainty can give organizations a strategic advantage by enabling them to anticipate and respond effectively to changing market conditions and emerging risks. In conclusion, uncertainty should not be viewed solely as a threat in the process of risk analysis. Instead, it should be embraced as an opportunity to gain deeper insights, foster innovation, enhance adaptability, promote learning, and achieve strategic advantage. 📢Keep following me and Qualistery for more GMP content and webinars #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing
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🚀 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝘁𝗵𝗲 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗶𝗻 𝗚𝘅𝗣-𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗲𝗱 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴: 𝘄𝗶𝘁𝗵 𝗠𝗮𝗻𝗮𝗴𝗲𝗱 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 & 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻! 🚀 Picture this: 𝘪𝘯 𝘵𝘰𝘥𝘢𝘺’𝘴 𝘭𝘪𝘧𝘦 𝘴𝘤𝘪𝘦𝘯𝘤𝘦 𝘭𝘢𝘯𝘥𝘴𝘤𝘢𝘱𝘦, 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘢𝘯𝘥 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦 𝘢𝘳𝘦𝘯'𝘵 𝘫𝘶𝘴𝘵 𝘣𝘶𝘻𝘻𝘸𝘰𝘳𝘥𝘴. 𝘐𝘥𝘦𝘢𝘭𝘭𝘺, 𝘵𝘩𝘦𝘺'𝘳𝘦 𝘦𝘮𝘣𝘦𝘥𝘥𝘦𝘥 𝘪𝘯 𝘦𝘷𝘦𝘳𝘺 𝘧𝘢𝘤𝘦𝘵 𝘰𝘧 𝘺𝘰𝘶𝘳 𝘰𝘱𝘦𝘳𝘢𝘵𝘪𝘰𝘯. 𝘈𝘯𝘥 𝘸𝘩𝘪𝘭𝘦 𝘵𝘩𝘪𝘴 𝘮𝘢𝘺 𝘴𝘰𝘶𝘯𝘥 𝘭𝘪𝘬𝘦 𝘢 𝘩𝘢𝘳𝘥-𝘵𝘰-𝘳𝘦𝘢𝘤𝘩 𝘪𝘥𝘦𝘢𝘭, 𝘪𝘵’𝘴 𝘢𝘤𝘵𝘶𝘢𝘭𝘭𝘺 𝘸𝘩𝘢𝘵 𝘰𝘶𝘳 𝘔𝘢𝘯𝘢𝘨𝘦𝘥 𝘘𝘶𝘢𝘭𝘪𝘧𝘪𝘤𝘢𝘵𝘪𝘰𝘯 & 𝘝𝘢𝘭𝘪𝘥𝘢𝘵𝘪𝘰𝘯 𝘚𝘦𝘳𝘷𝘪𝘤𝘦 𝘣𝘳𝘪𝘯𝘨𝘴 𝘵𝘰 𝘵𝘩𝘦 𝘵𝘢𝘣𝘭𝘦 – 𝘀𝗮𝗳𝗲𝗴𝘂𝗮𝗿𝗱𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗿𝗲𝗱𝘂𝗰𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗵𝗲𝗮𝗱𝗮𝗰𝗵𝗲𝘀. 𝗛𝗲𝗿𝗲'𝘀 𝗮 𝘀𝗻𝗮𝗽𝘀𝗵𝗼𝘁 𝗼𝗳 𝘁𝗵𝗲 𝘃𝗮𝗹𝘂𝗲 𝘄𝗲 𝗮𝗱𝗱 𝘁𝗼 𝘆𝗼𝘂𝗿 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀: 1️⃣ 𝗘𝗹𝗲𝘃𝗮𝘁𝗲 𝗡𝗲𝘄 𝗘𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁 & 𝗦𝗽𝗮𝗰𝗲𝘀: Kickstart your assets with surefire compliance and boosted efficiency. 2️⃣ 𝗡𝗲𝘄 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀 & 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗖𝗵𝗮𝗻𝗴𝗲𝘀: Navigate change without compromising on quality or safety. 3️⃣ 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗟𝗶𝗳𝗲𝗰𝘆𝗰𝗹𝗲 𝗠𝗮𝘀𝘁𝗲𝗿𝘆: Stay ahead of the curve, ensuring continuous compliance as products evolve. 4️⃣ 𝗔𝘂𝗱𝗶𝘁 & 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀: Approach regulatory checks with confidence and impeccable documentation. 5️⃣ 𝗦𝗼𝗹𝘃𝗶𝗻𝗴 𝗣𝗿𝗼𝗯𝗹𝗲𝗺𝘀 𝗟𝗶𝗸𝗲 𝗣𝗿𝗼𝘀: Expertly addressing challenges to maintain product integrity and market trust. 𝗢𝗽𝘁𝗶𝗻𝗴 𝗳𝗼𝗿 𝗼𝘂𝗿 𝗺𝗮𝗻𝗮𝗴𝗲𝗱 𝗤&𝗩 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗺𝗲𝗮𝗻𝘀: 🎯 Devoting yourself to core objectives while we handle complex qualifications. 📉 Driving down costs through strategic resource allocation. 📈 Embracing transparency with compliant procedures that offer peace of mind. Our bespoke strategy places your manufacturing, storage or lab needs into skilled custody - 𝗳𝗿𝗲𝗲𝗶𝗻𝗴 𝘆𝗼𝘂 𝘂𝗽 𝘁𝗼 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗲 𝗮𝗻𝗱 𝗹𝗲𝗮𝗱! Click 𝘧𝘰𝘭𝘭𝘰𝘸 for deep dives into each of these integral segments in the coming days! 𝗗𝗼 𝘆𝗼𝘂 𝘀𝗲𝗲 𝗵𝗼𝘄 𝗺𝗮𝗻𝗮𝗴𝗲𝗱 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗰𝗼𝘂𝗹𝗱 𝗿𝗲𝗱𝗲𝗳𝗶𝗻𝗲 𝘆𝗼𝘂𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀? Reach out to Adelheid Kotitschke and Marie Skinner to discuss your Q&V challenges and the potential for managed Q&V. #WeMakeHealthcareBetter #ArcondisQV #qualification #validaten #compliance #lifesciences
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Medical Writer & Career Coach | Advisory Boards | Pharma Advertising-Marketing-Commercial-Copywriting | CME-Needs Assessments | Symposiums
How do you change a system of which people are an integral part? Resistance to change is inherent to human behavior. Quality management in clinical trials is shifting from traditional approaches toward risk-based methodologies, which use central monitoring systems and advanced technologies. How can you have your team onboard to embrace these changes? Here is what you could do to ease your team toward changes : ✅ Rigorous training ✅ Improve communication styles among stakeholders ✅ Foster a culture of compliance through collaboration between regulatory bodies and industry players #clinicaltrials #ICHE8 #riskbasedqualitymangement #qualitymanagementsystem
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#Quality Culture Agent! I Manager Technical Training | Impactful Learning Solutions I #Business Impact
Compliance is not the ultimate goal of CGMP: never has been and never will be: it is a way of doing things, thought processes, critical thinking tools, and culture. The ultimate goal is good scientific decision making, and decisions are made by humans evaluating data via some process that has inherent risks… compliance is simply a prerequisite. Always remember – Quality always ensures compliance, but the reverse is almost never the case. -Peter Baker https://lnkd.in/df-K7cRw
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🔍 Ever wondered why some professionals excel in navigating deviations or non-conformances effortlessly while you might still be wondering ‘which one is which again?’ The secret lies in deep knowledge and strategic management skills, particularly in handling deviations. It's not just about identifying issues but transforming them into opportunities for improvement and innovation. Lets start off by clarifying the differences between Non-Conformances, Deviations and an Incident. Scroll through the PDF to find out more. 🚀 If you want to get the real insider view of how to manage deviations, then say hello to the Pharmuni course Deviation Management Course Designed by Quality Management nerds at Pharmuni, this course offers in-depth insights and practical strategies to master the art of managing deviations, ensuring compliance, and enhancing operational efficiency. What's in it for you? ✅Elevate your career with a certification in Deviation Management. ✅Gain the confidence to lead your organization through quality challenges. ✅Lifetime access Embrace the opportunity to become a key player in your organization's success story and boost your career. 👉 Get Started now: https://lnkd.in/dRJNnmN8 #Quality #Management #Risk #Mitigation #Professional #Development #Career #Growth #pharma #deviation #deviationmanagement #qms
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📚 𝗜𝗖𝗛 𝗤𝟭𝟰 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗠𝗮𝗿𝗰𝗵 𝟮𝟬𝟮𝟰 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝘁𝗼 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 ▶ Analytical procedure development is a critical step in ensuring the #quality of drug substances and products. ▶ It involves a systematic approach to measuring #attributes with specificity, accuracy, and precision. 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵 𝗶𝗻𝘁𝗼 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 ▶ The enhanced approach offers a more comprehensive way to develop and refine #analytical procedures. ▶ By conducting risk assessments, evaluating prior knowledge, and experimenting with #parameters, you gain a deeper understanding of how procedure parameters impact performance. 𝗞𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲 𝗮𝗻𝗱 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: 𝗘𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝗜𝗻𝗳𝗼𝗿𝗺𝗲𝗱 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻𝘀 ▶ Knowledge #management and risk management play pivotal roles in analytical procedure development and life cycle management. ▶ Prior knowledge from various sources, including internal expertise and scientific publications, informs decision-making throughout the process. 𝗥𝗼𝗯𝘂𝘀𝘁𝗻𝗲𝘀𝘀 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻: 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗥𝗲𝗹𝗶𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗖𝗼𝗻𝘀𝗶𝘀𝘁𝗲𝗻𝗰𝘆 ▶ Robustness studies are essential for assessing the ability of analytical procedures to withstand #variations in parameters. ▶ By deliberately testing these parameters, you can identify those that significantly influence procedure #performance. 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆: 𝗠𝗮𝗶𝗻𝘁𝗮𝗶𝗻𝗶𝗻𝗴 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗧𝗵𝗿𝗼𝘂𝗴𝗵𝗼𝘂𝘁 𝘁𝗵𝗲 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 ▶ An effective analytical procedure #control strategy is crucial for maintaining procedure performance throughout its life cycle. ▶ It encompasses a set of controls derived from development data, risk assessment, robustness studies, and prior knowledge. 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗣𝗼𝘀𝘁𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗖𝗵𝗮𝗻𝗴𝗲𝘀: 𝗘𝗺𝗯𝗿𝗮𝗰𝗶𝗻𝗴 𝗖𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁 ▶ Analytical procedures undergo changes throughout the product life cycle. ▶ The enhanced approach, with its focus on risk-based #categorization, established conditions, and postapproval change management protocols, facilitates efficient management and regulatory communication of these changes. 👉Follow Pharma Broadcast for more updates 🌟 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗶𝘀 𝗮 𝗱𝘆𝗻𝗮𝗺𝗶𝗰 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝘁𝗵𝗮𝘁 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝘀 𝗮 𝗯𝗹𝗲𝗻𝗱 𝗼𝗳 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗿𝗶𝗴𝗼𝗿, 𝗿𝗶𝘀𝗸 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲-𝗯𝗮𝘀𝗲𝗱 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻-𝗺𝗮𝗸𝗶𝗻𝗴. 𝗜𝘁 𝗶𝗻𝘃𝗼𝗹𝘃𝗲𝘀 𝗲𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝗶𝗻𝗳𝗼𝗿𝗺𝗲𝗱 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗶𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁. #AnalyticalExcellence #QualityControl #DrugDevelopment #Improvement #Science #ICH
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The right compliance management systems can generate actionable insights from data and enable proactive decision-making across the organization. Read this article in The Pharma Letter by Johan Holm, principal, commercial compliance managed services at IQVIA, as he discusses how life sciences companies can leverage compliance data to gain competitive advantage. Read more: https://bit.ly/3Qf14QV #CommercialCompliance #ConnectedIntelligence
How to turn risk management into competitive advantage
thepharmaletter.com
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Commercial Compliance Solutions Consultant | Empowering Lifesciences Compliance Teams | Global Innovative AI Solutions
Calling All Life Sciences Compliance Leaders! Dive into our latest blog on "Strategic Compliance Monitoring Planning for Compliance Leaders in 2024" In this blog, our subject matter expert has uncovered crucial insights: 1- Current Challenges in Commercial Compliance Monitoring. 2- Key Components of Strategic Compliance Monitoring. 3- Highlighting the Key Takeaways. Read it here: https://lnkd.in/dmaN5wHe #ComplianceMonitoring #LifeSciences #StrategicCompliance #qordata
Strategic Compliance Monitoring Planning for Compliance Leaders in 2024
qordata.com
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Life Sciences Executive, Board Member, Builder of high performing teams, Connect XEO Innovative and Diverse Leader, Mentor, Identical Twin Girl Mom
1moLove it! Gregg Sherman is a rock star!