Jimit Gandhi

Understanding Contact Duration: EU MDR Vs ISO 10993-1 In the realm of medical device regulation and biological evaluation, the duration of contact with the human body is a critical factor for ensuring safety and efficacy. Both the European Medical Device Regulation (EU MDR) and the International Organization for Standardization's ISO 10993-1 offer guidance on this aspect, albeit with differing categorizations. Understanding these distinctions is essential for navigating compliance and ensuring patient well-being. **EU MDR:** 1. Transient Contact: Brief or temporary contact with the body, typically less than 60 minutes. Surgical gloves are worn during a short medical procedure, such as a routine check-up or a simple wound dressing. 2. Short-Term Contact: Contact lasts up to 30 days beyond transient interaction. Wound dressings applied after surgery are meant to be removed within a few days to a couple of weeks. 3. Long-Term Contact: Extended contact with the body, typically exceeding 30 days. External prosthetic limbs worn daily by an amputee are intended to remain in contact with the body for an extended period, potentially years. **ISO 10993-1:** 1. Limited Contact: Brief or intermittent contact with the body for less than 24 hours. Surgical instruments used briefly during a procedure, such as forceps or scalpels, which have intermittent contact with bodily tissues. 2. **Prolonged Contact: Contact exceeding 24 hours up to 30 days but not involving permanent implantation. External cardiac monitors for heart rhythm monitoring to diagnose intermittent heart rhythm abnormalities or evaluate the effectiveness of medications or treatments. 3. Permanent Contact: Continuous contact with bodily tissues or fluids over an extended period for more than 30 days, typically involving implantation. Dental implants are surgically placed into the jawbone, providing continuous contact with bodily tissues for the lifespan of the implant. Distinguishing between the categorizations of contact duration in EU MDR and ISO 10993-1 is crucial for manufacturers and regulatory bodies alike. While EU MDR focuses on the intended duration of device use, ISO 10993-1 emphasizes the nature of the interaction with the body. By adhering to these guidelines, stakeholders can navigate the complexities of medical device regulation and ensure the highest standards of safety and efficacy for patients. What are your thoughts on this? #MDR #ISO10993-1 #Durationofcontact #compliance

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🍁 21 CFR Part 820.30(h): Design Transfer 🍁 21 CFR Part 820.30(h) outlines the requirements for design transfer in the medical device industry. It's a crucial step in ensuring that the device is produced consistently and reliably. 🍁 Key Requirements of 21 CFR Part 820.30(h) ☘ Establishment and maintenance of procedures: Manufacturers must have documented procedures for design transfer. ☘ Correct translation of design into production specifications: The design must be accurately transferred from the development phase to production. ☘ Verification of production process capability: Production processes must be capable of producing devices that conform to design requirements. ☘ Identification of process controls: Critical process parameters and quality characteristics must be identified and controlled. 🍁 Purpose of Design Transfer - Design transfer is essential to bridge the gap between design and production. It helps to: 🌱 Ensure product consistency and quality 🌱 Prevent design-related failures 🌱 Optimize production processes 🌱 Minimize rework and scrap This regulation is crucial for ensuring that the carefully developed and validated design of a medical device is accurately implemented in the manufacturing process, maintaining the safety and efficacy of the final product. 21 CFR Part 820.30(h) is a section of the U.S. Code of Federal Regulations that pertains to design transfer in medical device quality system regulations. This regulation is part of the broader Quality System Regulation (QSR) enforced by the Food and Drug Administration (FDA). #engineering #systemengineering #mechanicalengineering #productdevelopment #productdesign #valueengineering #valueanalysis #VAVE #npd #medicaldevice #medicaldevices #eumdr #ivdr #regulatoryaffairs #valueoptimization #productdevelopment #innovation #efficiency #startyourjourney #VMCoach #usfda #qms #qmsr #iso13485 #regulatoryaffairs #regulatorycompliance #qualitysystems #medtech #medicaldevices #healthcareindustry

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✅️ 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗮𝗻 𝗲𝗤𝗠𝗦: 𝗞𝗲𝘆 𝗦𝘁𝗲𝗽𝘀 𝗳𝗼𝗿 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 🎯 Implementing an electronic Quality Management System (eQMS) streamlines quality processes and supports regulatory compliance, making it a valuable asset for regulated industries like pharmaceuticals and medical devices. Here’s a quick guide to a successful eQMS implementation: 1️⃣ Define Goals & Requirements: Identify your quality management objectives (e.g., document control, CAPA automation) and determine specific regulatory requirements (📝 better in URS) 2️⃣ Assemble a Cross-Functional Team: Form a team from quality, IT, and compliance departments to ensure diverse needs are met and align the project with organizational goals. 3️⃣ Select the Right Vendor: Choose an eQMS provider whose platform is flexible, scalable, and compliant, and fits your organization’s unique requirements. 4️⃣ Optimize Processes: Review and refine existing workflows, removing inefficiencies to maximize the eQMS’s impact. 5️⃣ Customize & Configure: Tailor the system to your processes, setting up user roles, permissions, and workflows to align with compliance standards. 6️⃣ Train & Validate: Train your team for smooth adoption, and validate the system to confirm functionality and regulatory compliance. 7️⃣ Monitor & Optimize: Launch with a phased approach, gather feedback, and make continuous improvements for long-term success. 𝘼 𝙬𝙚𝙡𝙡-𝙞𝙢𝙥𝙡𝙚𝙢𝙚𝙣𝙩𝙚𝙙 𝙚𝙌𝙈𝙎 𝙬𝙞𝙡𝙡 𝙚𝙣𝙝𝙖𝙣𝙘𝙚 𝙦𝙪𝙖𝙡𝙞𝙩𝙮 𝙢𝙖𝙣𝙖𝙜𝙚𝙢𝙚𝙣𝙩, 𝙞𝙢𝙥𝙧𝙤𝙫𝙚 𝙘𝙤𝙢𝙥𝙡𝙞𝙖𝙣𝙘𝙚, 𝙖𝙣𝙙 𝙙𝙧𝙞𝙫𝙚 𝙚𝙛𝙛𝙞𝙘𝙞𝙚𝙣𝙘𝙮 𝙖𝙘𝙧𝙤𝙨𝙨 𝙮𝙤𝙪𝙧 𝙤𝙧𝙜𝙖𝙣𝙞𝙯𝙖𝙩𝙞𝙤𝙣.

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#CSV's Importance in the #PharmaceuticalIndustry #CSV, or #ComputerSystemValidation, is a critical process in the pharmaceutical industry due to the stringent regulatory requirements and the paramount importance of patient safety. Here's why CSV is so essential: 1. #RegulatoryCompliance: * #FDA21 #CFR #Part11: This US FDA regulation outlines specific requirements for electronic records and signatures in the pharmaceutical industry. CSV ensures compliance with these regulations, preventing legal and financial penalties. * #OtherRegulatoryBodies: Similar regulations exist in other countries, making CSV a global standard for pharmaceutical quality. 2. #DataIntegrity: * Accurate and Reliable Data: CSV guarantees that data generated by computer systems is accurate, reliable, and consistent. This is crucial for research, development, manufacturing, and quality control. * Traceability: CSV ensures that data can be traced back to its source, enabling investigations and audits. 3. #PatientSafety: * #ProductQuality: CSV helps maintain the quality of pharmaceutical products throughout their lifecycle. Errors in data or systems can lead to safety issues. #RiskMitigation: By identifying and mitigating risks associated with computer systems, CSV helps prevent errors that could affect patient health. 4. #Efficiency and #Productivity: * Streamlined Processes: Well-validated systems can improve efficiency and productivity by automating tasks and reducing manual errors. * Business Continuity: CSV helps ensure that computer systems are reliable and can continue to function in the event of disruptions. 5. #RiskManagement: * #RiskAssessment: CSV involves identifying and assessing potential risks associated with computer systems. * #RiskMitigation: By implementing appropriate controls, CSV helps mitigate these risks and protect the organization's reputation. In conclusion, CSV is a fundamental aspect of pharmaceutical manufacturing, ensuring regulatory compliance, data integrity, patient safety, efficiency, and risk management. It is a cornerstone of quality assurance in the industry. #Consulting at #WeAreForvisMazars #RiskAutomation #CSV #PharmaIndustries #WeAreForvisMazars #NewGlobalNetwork #ForvisMazars #ForvisMazarsinIndia Rajan Arora Shree Parthasarathy Manoj Ajgaonkar Kartikeya Raman Nitin Sehgal

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🚀 How to Validate AI Systems for GxP Compliance 🧑‍🔬 In GxP-regulated industries, introducing AI models like GPT-4 isn't just about innovation—it's about ensuring compliance with strict standards like GMP, GCP, and GLP. In my latest article, I break down a step-by-step guide on how to validate an LLM-based system in regulated environments. From risk assessment to performance testing, I share practical insights and real-world examples of using GPT-4 for clinical trial document summarization. Curious how AI can fit into GxP while maintaining data integrity and regulatory compliance? Check it out now! 👇 #GxPValidation #AICompliance #PharmaTech #ClinicalTrials #HealthcareAI #DataIntegrity #MachineLearning #GxP

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Honored to have been part of an engaging panel discussion on #Cybersecurity in #Pharma Industry organized by #ETPharma. $4.88 Mn is global average cost of data breach while in Healthcare its whopping $10 Mn as per IBM Data breach report 2024. Ransomware attacks in Pharma is most prevalent we have witnessed in recent times and must need to be taken as a holistic security program. The conversation emphasized the increasing importance of protecting sensitive data and the challenges in implementing new initiatives and changes due to GMP (Good Manufacturing Practices)/FDA regulations, ensuring compliance, and addressing cyber threats. As #digitaltransformation accelerates, safeguarding intellectual property, patient data, and operational systems is more critical than ever. Thanks to #ETPharma for organizing such a meaningful event. Looking forward to driving impactful cybersecurity initiatives in this space! Amandeep Singh Bawa Shirish G Belapure

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"Stay up-to-date with the latest regulations and guidelines in the pharmaceutical industry with our comprehensive Drug Regulatory Affairs course. Learn how to ensure compliance and bring new drugs to the market efficiently and effectively." Check out our website www.ibri.org.in, email I'd [email protected] or call us on +91 9971441910 to know more. #drugregulatoryaffairs #pharmaregulations #pharmaceuticalindustry #regulatoryaffairstraining #pharmaprofessionaldevelopment #ibricourses #pharmacourses

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🔍 **ISO 13485 Certification Checklist: Is Your Medical Device Company Ready?** Achieving ISO 13485 certification is a crucial step toward ensuring regulatory compliance and building trust in the medical device industry. But navigating the certification process can be overwhelming without the right tools. 💡 Our **ISO 13485 Certification Checklist** simplifies the journey by helping you: ✅ Understand the essential requirements   ✅ Organize necessary documentation   ✅ Optimize your quality management system   ✅ Steer clear of common certification mistakes Ready to start? Dive into the full checklist in my latest blog post and take your first step toward ISO 13485 certification! 🔗 https://lnkd.in/gte8xsgn #ISO13485 #MedicalDevices #CertificationChecklist #QualityManagement #Compliance #MedicalIndustry #QualityAssurance

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"𝗚𝗗𝗣𝗥 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟴 - 𝗖𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝗯𝗹𝗲 𝘁𝗼 𝗰𝗵𝗶𝗹𝗱'𝘀 𝗰𝗼𝗻𝘀𝗲𝗻𝘁" Article 8 of the GDPR is essential for 𝗽𝗿𝗼𝘁𝗲𝗰𝘁𝗶𝗻𝗴 𝗰𝗵𝗶𝗹𝗱𝗿𝗲𝗻'𝘀 𝗽𝗲𝗿𝘀𝗼𝗻𝗮𝗹 𝗱𝗮𝘁𝗮. This article 𝗱𝗲𝗮𝗹𝘀 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗰𝗼𝗻𝘀𝗲𝗻𝘁 𝘄𝗵𝗶𝗹𝗲 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴 𝗽𝗲𝗿𝘀𝗼𝗻𝗮𝗹 𝗱𝗮𝘁𝗮 𝗼𝗳 𝗰𝗵𝗶𝗹𝗱𝗿𝗲𝗻, it also acknowledges that children may not fully understand the risks/consequences of data processing, hence required extra safeguards (read more here https://lnkd.in/gQiDsa-c). 𝘾𝙝𝙚𝙘𝙠 𝙤𝙪𝙩 𝙢𝙮 𝙥𝙧𝙚𝙫𝙞𝙤𝙪𝙨 𝙥𝙤𝙨𝙩𝙨 𝙛𝙤𝙧 𝙢𝙤𝙧𝙚 𝙞𝙣𝙨𝙞𝙜𝙝𝙩𝙨: 𝗘𝗺𝗯𝗮𝗿𝗸𝗶𝗻𝗴 𝗼𝗻 𝗮 𝗣𝗮𝘁𝗵 𝘁𝗼 𝗠𝗮𝘀𝘁𝗲𝗿 𝗚𝗗𝗣𝗥 𝗮𝗻𝗱 𝗣𝗿𝗶𝘃𝗮𝗰𝘆: https://lnkd.in/gniaEMdE 𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟭 𝗚𝗲𝗻𝗲𝗿𝗮𝗹 𝗽𝗿𝗼𝘃𝗶𝘀𝗶𝗼𝗻𝘀 𝗼𝗳 𝗚𝗗𝗣𝗥: https://lnkd.in/giyz8fEs 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟭 - 𝗦𝘂𝗯𝗷𝗲𝗰𝘁 𝗠𝗮𝘁𝘁𝗲𝗿 & 𝗢𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲𝘀 https://lnkd.in/gJNNnek9 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟮 - 𝗠𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝗦𝗰𝗼𝗽𝗲 https://lnkd.in/gJNNnek9 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟯 - 𝗧𝗲𝗿𝗿𝗶𝘁𝗼𝗿𝗶𝗮𝗹 𝘀𝗰𝗼𝗽𝗲 https://lnkd.in/gTT35Gmr 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟰 - 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 https://lnkd.in/gDcVqADS 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟱 - 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗿𝗲𝗹𝗮𝘁𝗶𝗻𝗴 𝘁𝗼 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴 𝗼𝗳 𝗽𝗲𝗿𝘀𝗼𝗻𝗮𝗹 𝗱𝗮𝘁𝗮: https://lnkd.in/gcNU4uyE 𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟲 - 𝗟𝗮𝘄𝗳𝘂𝗹𝗻𝗲𝘀𝘀 𝗼𝗳 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴: https://lnkd.in/gk_CnhbX  𝗔𝗿𝘁𝗶𝗰𝗹𝗲 𝟳 - 𝗖𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗰𝗼𝗻𝘀𝗲𝗻𝘁: https://lnkd.in/gC7FtJPg Share your thoughts and questions below. #GDPR #Privacy #DataPrivacy #GDPRCompliance #PrivacyMatters #GDPRRegulation #Cybersecurity #InformationSecurity #LegalRequirements #DataGovernance #PrivacyLaw #Govermnance #RiskManagement #Compliance #DataProtection #CyberPrivacy #Compliance #PrivacyFirst #Upskilling #LinkedIn #Consent #PrivacyRights #ChildrenPrivacy #ParentalConsent

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Cyber Security in Industry...

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What We Can Learn from CAPA Failures? Even with robust CAPA systems in place, quality issues can still arise. One of the primary reasons is the lack of connectivity and integration of CAPA with the overall CTMS (Clinical Trial Management System). This disconnection makes it challenging to document and track corrective and preventive measures effectively. Here’s why: 🔍 Root Cause Identification: Without seamless integration, identifying the root cause of issues can become disjointed, leading to incomplete or inaccurate data. 🔄 Process Improvement: Effective process improvement relies on comprehensive data flow. Gaps in system integration hinder the ability to streamline processes and implement effective changes. ⚠️ Risk Management: Disconnected systems make it difficult to manage risks proactively. An integrated CTMS and CAPA system ensures that potential risks are identified and mitigated in a timely manner. 📊 Quality Enhancement: Continuous quality enhancement requires a holistic view of all data. Lack of integration prevents the full potential of CAPA initiatives, leading to recurring issues. 🎯 Fully Targeted Training: Training programs must be based on comprehensive insights from CAPA systems. Without integration, it’s challenging to identify all areas requiring improvement. 📜 Regulatory Compliance: Compliance with regulations demands thorough documentation and tracking. Integrated systems ensure that all actions are recorded, making audits and inspections smoother. ⭐ Customer Satisfaction: Ultimately, the goal is to enhance customer satisfaction by delivering high-quality outcomes. Integrated systems enable a more reliable and efficient process, fostering trust and satisfaction. At AQ, we understand the critical need for integrated CAPA and CTMS systems. By leveraging advanced technology and innovative solutions, we aim to bridge these gaps, ensuring comprehensive documentation, effective tracking, and enhanced usability. Visit www.aq-trials.com to learn more about our solutions and how we can help you achieve seamless integration for superior quality management in clinical trials. #ClinicalTrials #CAPA #CTMS #QualityManagement #RiskManagement #ProcessImprovement #CustomerSatisfaction #RegulatoryCompliance #Pharma #Biotech #LifeSciences #drugdevelopment #NHS #NHSdigital #compliance

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💥 21 CFR Part 820.30(b) - FDA's Quality System Regulation for medical devices. 💥 "Focuses on Design and Development Planning for Medical Devices" 💥 🎆 21 CFR 820.30(b) states: "Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves." 🎆 Key points about this regulation: 1. Design Planning: Manufacturers must establish and maintain plans for design and development activities. 2. Responsibility: The plans should define who is responsible for implementing various aspects of the design process. 3. Interfaces: The plans must identify and describe how different groups or activities interact and contribute to the design process. 4. Dynamic Process: These plans should be reviewed, updated, and approved as the design and development process progresses. 5. Documentation: This implies that the planning process and its outcomes should be documented. 🎇 This regulation is directly relevant to your project, particularly in relation to the following deliverables: - Design and Development Documentation - Change Management Documentation - Life Cycle Management Documentation 🎆 To comply with this regulation, you should ensure that your project includes: 1. Comprehensive design and development plans 2. Clear definition of roles and responsibilities 3. Documentation of interfaces between different teams or processes 4. Regular review and update of design plans 5. Approval processes for design plans and their updates 🎆 Manufacturers shall establish procedures to define the activities and steps involved in the design and development process. - DDP Plan The DDP plan should consider factors like: 1. Identifying the intended use of the device and the needs of the user and patient. 2. Specifying the user needs and how they will be translated into design requirements. 3. Planning for design reviews throughout the development process to assess if the design meets the requirements. 4. Establishing a process for addressing incomplete, ambiguous or conflicting design requirements. https://lnkd.in/gmxxynhT https://lnkd.in/gmxxynhT #engineering #systemengineering #mechanicalengineering #productdevelopment #productdesign #valueengineering #valueanalysis #VAVE #npd #medicaldevice #medicaldevices #eumdr #ivdr #regulatoryaffairs #valueoptimization #productdevelopment #innovation #efficiency #usfda #qms #qmsr #iso13485 #regulatoryaffairs #regulatorycompliance #qualitysystems #medtech #medicaldevices #healthcareindustry

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End-to-end quality managers in life sciences embody: - The vision and mission of a chief quality officer - The strategy and direction of a head of quality - The regulatory acumen of GxP compliance SME - The communication skills of a top trainer - The documentation skills of a technical writer - The analytical skills of a data integrity expert - The continuous improvement focus of a manager To thrive in the evolving landscape of life sciences, become an end-to-end quality manager. They aren't mythical creatures; numerous end-to-end quality managers are making impactful contributions behind the scenes. What additional traits define an end-to-end quality manager? 

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🚀 Join TÜV Rheinland at Regulatory Affairs Professionals Society (RAPS) Convergence 2024 in Long Beach, California!   We’re excited to announce that Volker Schlueter, Global Business Manager IVD at TÜV Rheinland Group, will be a part of the panel discussion: "Structured Dialogue for (IVD) Medical Devices in Europe: Now Will Finally Get Some Answers".   This session will focus on the structured dialogue process as outlined in MDCG 2022-14, discussing how this voluntary initiative can improve the efficiency and predictability of conformity assessments for IVD medical devices. Panelists will share real-world experiences and insights on how structured dialogue between manufacturers and notified bodies can help streamline the regulatory process while maintaining the independence of the NBs.   Key takeaways: 🔹Understanding the structured dialogue process within a notified body - what it should and shouldn't cover in practice 🔹Insights from Industry, Notified Bodies, and EU regulators on how structured dialogue is perceived 🔹Experiences from those who have implemented structured dialogue   Visit us at booth #706, where Volker and the TÜV Rheinland team will be available to answer your questions and discuss how we can support your path to regulatory compliance.   #RAPSConvergence #IVD #MedicalDevices #StructuredDialogue #RegulatoryCompliance #TUVRheinland Dr Nicholas T. Kirkland Jamie Evora Ahmad Omar Kelly Bertrand, PMP Ryan Dillon Florian Staudigel

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ISO 42001: A Framework for Responsible AI Adoption As AI rapidly transforms industries, ISO 42001 emerges as a standard for establishing robust AI governance. This framework, I believe will become crucial for organisations across healthcare and pharmaceutical sectors to ensure ethical, transparent, and accountable AI implementation. "How do you use AI in your organisation to get the 'Job' done?" Key benefits: > Mitigates AI risks: Identifies and addresses biases, errors, and unintended consequences. > Promotes ethical AI: Ensures transparency, fairness, and accountability. > Builds trust: Fosters confidence among stakeholders and the public. > Ensures compliance: Aligns with legal requirements and industry best practices. Challenges: > Evolving landscape: Requires continuous adaptation to keep pace with AI advancements. > Implementation: Demands expertise and resources for effective AI management. > Limited scope: Focuses primarily on technical aspects, not broader societal implications. > It is new! A full slide deck will be available to participants who attended the #PharmaDeviceForum in #melbourne on 23-24th May 2024. #QualityManagement #HealthcareExcellence #pharma #pharmaceutical #Governance PharmOut

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