Mahendra Borad

I’m honored to step into the role of Chief Operations Officer (COO) and grateful to the Board, Dr. Petar Vazharov (CEO) and the leadership team of Lotus Pharmaceutical Co., Ltd for their trust and confidence. As we continue on our growth journey, I’m focused on five key priorities to strengthen our foundation, which I call #SCOPE: 🔹 #Simplification: Streamlining processes for greater efficiency 🔹 #Compliance: Upholding the highest standards of safety and quality 🔹 #Optimization: Maximizing resources talent to drive better outcomes 🔹 #Performance: Aiming to exceed our goals and deliver results 🔹 #Encouraging: Fostering a culture of collaboration, innovation, and growth I’m energized by the opportunity to work alongside a talented team as we continue to innovate and make a positive impact in healthcare. Together, we will works Towards a brighter Tomorrow! #Leadership #Healthcare #Innovation #Growth #Teamwork #COO

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Water is fluid, soft, and yielding. But water will wear away rock, which is rigid and cannot yield. As a rule, whatever is fluid, soft, and yielding will overcome whatever is rigid and hard. This is another paradox: what is soft is strong. ~ Lao Tzu #strength #overcome #softness #yielding #pharmacovigilance

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Here are some insights on hiring @intuitive india from Patrick Caines (senior director, Global Post-Market Surveillance) and Meher Muttanapalli - Great Time to Join Intuitive to make the difference in enhanced patient care!!!

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Response to Survey on CAPA FDA 483 Citations: Reflections and Recommendations A few weeks ago, I asked why CAPA remains one of the top areas of FDA observations noted on 483s. Nearly 70% of participants highlighted "lack of technical rigor" and "speed of KPIs vs quality of work." Here are some general recommendations (not all-inclusive) on actions to consider for improving or setting up a CAPA system to achieve better outcomes. Technical Rigor Having an established procedure for conducting Corrective and Preventive Actions (CAPA) is essential. There are many tools available for conducting investigations. One highly recommended methodology is DMAIC (Define, Measure, Analyze, Improve, and Control). DMAIC is a methodical, data-centric approach to problem-solving that aims to identify and rectify inefficiencies within a process, thereby enhancing outcomes and ensuring improvements are consistent and predictable. Typically, industries use DMAIC to drive process excellence, reduce variation, and lower costs. DMAIC is also crucial for training and certifying Green Belts and Black Belts in many firms. Companies with an established Process Excellence group should leverage this expertise to embed these practices into the CAPA system. CAPA KPIs vs Quality of Work Historically, firms have established lagging CAPA metrics, such as CAPA aging and CAPA effectiveness, which are part of their Quality Plans and Management Reviews but are not reviewed routinely. Some firms conduct Management Reviews quarterly, bi-annually, or annually. To improve the use of KPIs, firms must treat CAPAs like projects. For example, every CAPA phase (investigation, action plan, effectiveness, phase extensions) should have a defined number of deliverables. Firms need to review how well these deliverables are executed and if they are on time. One way to do this is to measure the % Attainment of Deliverables on time, which is a leading indicator for the CAPA phase. Resource Management Another significant constraint at many firms is the lack of focus on resources to work on CAPA. Resource management and allocation is always a balancing act. There is no perfect setup for a CAPA system and structure. However, here is a short list of roles that can help improve the quality of work. Improving technical rigor, as mentioned earlier, should enhance the quality of work. CAPA Administrator: Monitors the portfolio of all CAPAs, manages the CAPA board, and handles escalations. CAPA Specialists: Assess CAPA compliance with procedures and content. Independent Reviewer: Evaluates CAPA compliance and technical rigor, working with CAPA owners to resolve issues. CAPA Investigators: A dedicated team that works on critical steps of the CAPA, such as validating the problem statement, scope, defining initial mitigations/interim controls, and root cause analysis. This team partners with cross-functional teams to define action plans and implementation activities.

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Using properly trained auditors increase the possibility of discovering issues before they become problems

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Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. Guidance for Industry and Food and Drug Administration Staff, August 2024. FDA is issuing this guidance to help manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting (VMSR) Program, an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to FDA in a summary format on a quarterly basis. FDA’s VMSR Program is intended to yield benefits for both FDA and the public, such as increasing transparency for the public, helping FDA to process certain malfunction reports efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers. This guidance is intended to explain, but not change, the conditions of the VMSR Program.

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FDA's Obligation: To conduct inspections to confirm compliance 👮🏻🔎 Multiple comments to the FDA's QMSR centered around FDA accepting ISO audits and resulting certifications to ISO 13485 𝘪𝘯 𝘭𝘪𝘦𝘶 𝘰𝘧 FDA inspections 🙏🏻 One comment stated that FDA should allow firms with ISO certification to utilize that certification to demonstrate compliance with the QMSR, in furtherance of global harmonization. 🤝 FDA 𝗱𝗶𝘀𝗮𝗴𝗿𝗲𝗲𝘀 and clearly lays out its obligations which are: To inspect medical device manufacturers to 𝘤𝘰𝘯𝘧𝘪𝘳𝘮 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦 with the requirements of the FD&C Act and its implementing regulations...such as parts: ✅ 820 - Quality Management System Regulation ✅ 803 - Medical Device Reporting ✅ 806 - Corrections and Removals ✅ 821 - Medical Device Tracking ✅ 830 - Unique Device Identifier FDA believes that by incorporating the requirements of ISO 13485 within the QMSR, this will simplify manufacturers’ ability to comply with both ISO 13485 and requirements in the FD&C Act and its implementing regulations. So for the following groups of firms, this is either impactful or not: 1️⃣ US-domestic - QMSR + ISO 13485 (no ISO certification needed) 2️⃣ US-EU - QMSR + ISO 13485 + Certification to ISO 13485 3️⃣ EU-domestic - Certification to ISO 13485 (no QMSR compliance needed) 4️⃣ EU-US - Certification to ISO 13485 + QMSR Please share - what are your thoughts about FDA's decision NOT to accept ISO audits❓ ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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USFDA: 510 (K) vs PMA Simple Understating In the U.S., medical devices must go through the FDA's regulatory pathways before they can be marketed. The two primary pathways are 510(k) and PMA (Pre-Market Approval). These differ significantly in terms of requirements, time, and the risk level of the devices they apply to. 510(k) (Premarket Notification) Purpose: Used to demonstrate that a new device is substantially equivalent to a device that is already legally marketed in the U.S. (called a "predicate device"). Device Classification: Typically applies to Class I and Class II medical devices, which are considered low to moderate risk. Review Process: The manufacturer submits a premarket notification to the FDA. The manufacturer must demonstrate that the device is at least as safe and effective as a legally marketed predicate device. No clinical trials are generally required unless there are significant technological differences. Timeline: Typically shorter, with an average review time of 3-6 months. Cost: Less expensive, with fees significantly lower than PMA. Examples: Surgical gloves, blood pressure cuffs, and some diagnostic devices. PMA (Premarket Approval) Purpose: This is the most stringent FDA review process and is required when there is no predicate device, or for devices that are high risk. Device Classification: This applies to Class III medical devices, which are considered high-risk and typically support or sustain life, or present a potential unreasonable risk of illness or injury. Review Process: The manufacturer must provide clinical data to prove that the device is safe and effective for its intended use. This typically involves extensive preclinical and clinical trials. The FDA conducts a more rigorous scientific and regulatory review compared to 510(k). Timeline: Longer, with reviews often taking 6-12 months or more. Cost: More expensive due to the extensive testing and regulatory documentation required. Examples: Heart valves, pacemakers, and implantable devices. Key Differences: Risk Level: 510(k) for lower-risk devices; PMA for high-risk devices. Data Requirements: 510(k) requires substantial equivalence, while PMA requires proof of safety and efficacy through clinical data. Time and Cost: PMA is generally much more time-consuming and costly than 510(k).

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"you can If you will" D.M.A.I.C. The problem-solving approach that drives Lean Six Sigma. It’s a five-phase method "Define, Measure, Analyze, Improve and Control" for improving existing process problems with unknown causes.

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Simple illustration of the IQOQPQ for our reference.

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The FDA has released the Quality Management System Regulation (QMSR) Final Rule for the Current Good Manufacturing Practice (CGMP). What does this mean in practical terms? 💡 In summary, the FDA has aligned its Quality System (QA) Requirement with the international consensus standard ISO 13485. The new name for this regulation is the Quality Management System Regulation (QMSR). Now there remain only few discrepancies to the ISO 13485. The additional requirements mainly concern: - Complaint records, device labelling and packaging - Consistency with other FDA requirements - Some adjustments to terminology For further info, look under: https://lnkd.in/dqdqHzyK

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There are still a few hours left to take part in the Scope of Practice survey - Details below!

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Brazilian GMP certificate validity extended to 4 yrs On April 1, 2024, the new ANVISA regulation RDC 850 (2024) has entered into force extending the validity of Brazilian GMP certificates (also called CBPF) from 2 yrs to 4 yrs. However, this is applicable only for manufacturers holding an MDSAP certificate. Based on my experience, ANVISA already started issuing B-GMP certificates with 4 yrs validity, even if the application was submitted in Q4 2023. Link to the regulation (in Portuguese): https://lnkd.in/edaYezZm With this ANVISA delivers on their regulatory agenda for 2024/25 (see also details in one of my previous posts: https://lnkd.in/eYRkF6qc) #anvisa #medicaldevice #regulatoryaffairs #medtech #mdsap #bgmp #cbpf #rdc850

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🌟 ISO 13485: The Foundation of Medical Device Business Success 🌟 In the rapidly evolving medical device industry, quality isn’t just a requirement—it’s a key competitive advantage. ISO 13485 lies at the core of ensuring consistent quality, safety, and regulatory compliance. It’s no surprise that companies adopting ISO 13485 are better equipped to build trust, optimize processes, and deliver exceptional outcomes. A recent industry survey highlights the significant benefits of implementing this standard, ranging from operational excellence to enhanced customer confidence. Explore more industry insights about ISO 13485:2016 in the survey below. 📊 #ISO13485 #MedicalDevices #QualityManagement #Innovation

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Useful additional considerations if you are considering a controversial trip down the 'human error' route.

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Did You Know? Type 1 diabetes is the most common metabolic disorder among children. Children and parents are often caught unaware by the diagnosis. To learn to live every day with this metabolic disorder is a challenge for children, adolescents, and their families. A Unique Event! On October 26th, 2024, we invite you to attend at the University of Porto (in Portugal) (Centro Regional do Porto Universidade Católica Portuguesa) an event where affected children and families have the opportunity to speak and exchange directly with health care providers, regulators and industry. Simultaneous translation into English or Portuguese is assured for all attendees of the event.  This unique event provides a neutral platform to enable and increase communication and collaboration between families with children facing this disease, as well as regulators, medical experts and industry professionals exploring best practices for optimal treatment. https://lnkd.in/dG5XMaVB This event is organized by #RAPS Portugal LNG.

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