This powerpoint presentation was made by Jennifer McEntire, Ph.D, with the Institute of Food Technologists to the joint FDA/FSIS meetings held in Washington D.C. on December 9 & 10 regarding traceability for produce.
The Food Safety Modernization Act establishes new requirements for tracing foods through the supply chain. It will require recordkeeping for high-risk foods and the ability to trace foods one step forward and one step back. This poses challenges due to the complexity of distribution systems and suppliers. Regulators want faster and more consistent tracing to help narrow the scope of foodborne illness outbreaks. The new law requires the FDA to define high-risk foods and establish tracing requirements within two years, with some exemptions for small farms. It also establishes pilots to demonstrate tracing technologies and costs. Industry should view tracing as a food safety tool and work with regulators to develop effective and cost-efficient tracing systems.
The International Food Information Service (IFIS) is an established provider of food science and technology information that collects, manages, and distributes information to industry professionals. IFIS produces the Food Science and Technology Abstracts database, the world's largest database covering food science. IFIS's mission is to communicate food science knowledge globally to stimulate education, research, and training for humanity's benefit. IFIS helps food companies stay informed of advances, support R&D, ensure food safety, and bring new products to market.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
How the TGA uses implant registry data: Experience with the Australian Orthop...TGA Australia
The recent TGA review of devices has foreshadowed a much greater role for registries in monitoring the long and intermediate term safety of new devices. This presentation provides an example of an established device registry to explore issues such as governance, funding, record linkage, reporting etc.
The Food Safety Modernization Act establishes new requirements for tracing foods through the supply chain. It will require recordkeeping for high-risk foods and the ability to trace foods one step forward and one step back. This poses challenges due to the complexity of distribution systems and suppliers. Regulators want faster and more consistent tracing to help narrow the scope of foodborne illness outbreaks. The new law requires the FDA to define high-risk foods and establish tracing requirements within two years, with some exemptions for small farms. It also establishes pilots to demonstrate tracing technologies and costs. Industry should view tracing as a food safety tool and work with regulators to develop effective and cost-efficient tracing systems.
The International Food Information Service (IFIS) is an established provider of food science and technology information that collects, manages, and distributes information to industry professionals. IFIS produces the Food Science and Technology Abstracts database, the world's largest database covering food science. IFIS's mission is to communicate food science knowledge globally to stimulate education, research, and training for humanity's benefit. IFIS helps food companies stay informed of advances, support R&D, ensure food safety, and bring new products to market.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
How the TGA uses implant registry data: Experience with the Australian Orthop...TGA Australia
The recent TGA review of devices has foreshadowed a much greater role for registries in monitoring the long and intermediate term safety of new devices. This presentation provides an example of an established device registry to explore issues such as governance, funding, record linkage, reporting etc.
TGA presentation: Update on recent activitiesTGA Australia
This document provides an update on recent activities and ongoing reforms from the Scientific Evaluation Branch of the Therapeutic Goods Administration of Australia. It discusses implemented reforms such as streamlined variations for prescription medicines, utilizing evaluation reports from comparable overseas regulators, and biological and biosimilar medicines naming. Upcoming reforms addressed include improved labeling of neuromuscular blocking agents and regulation of fecal microbiota transplantation material. Approval times for different categories of medicines over the past years are also presented.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
This document discusses preparing for the upcoming EU Medical Device Regulation (MDR), which aims to improve patient safety but remains incomplete. It outlines an agenda including introductions, a discussion of MDR's likely impact on clinical evidence, transparency, and traceability, and common CEO questions. The discussion covers basic compliance questions companies should consider, mapping a compliance plan over the transition period, and notes that companies should start preparing now rather than waiting for full clarity.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
Presentation: Risk minimisation in the Australian contextTGA Australia
This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)
Safer Technologies Program for Medical DevicesEMMAIntl
FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available options that treat diseases that are non-life threatening...
What the FDA’s May 2021 Report on Foodborne Illness in Retail Delis RevealsSafetyChain Software
Dr. Rolando González from TAG unpacks the recent FDA recent report on foodborne illness in retail delis. Regardless of whether you are responsible for food safety in a deli located in a retail store or work in another manufacturing setting, attend!
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
Aegate Symposium Frankfurt June 2015 - Jan saevelsAegate
The APB, Belgium's national pharmacy association, has partnered with Aegate for 7 years to enhance patient safety through their serialization and traceability system. Aegate provides real-time recall warnings, expiration alerts, and counseling messages to pharmacists at the point of dispensing. This integration has helped APB efficiently manage recalls, prevent expired medications from being dispensed, and ensure important product information reaches pharmacists and patients. The Aegate-APB partnership has strengthened pharmacovigilance in Belgium through swift investigation and resolution of issues like a batch labeling error.
Synthetic biology is a novel field that finds its origin at the intersection of biology and engineering. It involves designing and construction of biological systems or devices that can be applied in varied domains to get specified results. It’s a multidisciplinary effort made by scientists to understand the functioning of biological organisms, cells & genes and implementation of artificial genetic processes to give specific characteristics to an organism.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
Aegate Symposium Frankfurt June 2015 - Graham commercial publishAegate
The document discusses Aegate's role in providing services related to the European Union's Falsified Medicines Directive. It outlines Aegate's selection to provide national blueprint systems for verification across Europe. It invites partners to join Aegate's ecosystem partner programme to gain access to information, best practices, and opportunities to benefit from Aegate's revenue sharing and certification programmes for pharmacies and software providers across Europe.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
Regulatory Compliance in the Pharmaceutical Supply ChainAudioEducator
The document summarizes key points about regulatory compliance in the pharmaceutical supply chain. It discusses how the FDA launched initiatives in 2002 to modernize drug manufacturing regulations using modern risk management and quality techniques. This was driven by an increase in adverse drug events and recalls. The FDA introduced new GMP regulations for the 21st century requiring comprehensive patient risk management and manufacturing approaches based on scientific principles. The new regulations can consider all products at a facility "adulterated" if any GMP system fails inspection, potentially wiping out revenue from a single high-risk product. The presentation provides background on these changes to FDA regulation and their impact on the pharmaceutical industry.
Tools Available to the FDA to Assess Patient SafetyEMMAIntl
Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients...
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
Managing Regulatory Compliance and Food safety With Cloud Data Supervision-Ch...Simba Events
The document discusses Selerant's Compliance Cloud, a cloud-based platform that helps companies manage regulatory compliance and food safety. It provides structured databases of food legislation limits from over 700,000 records across 200 countries. It also monitors food alerts, recalls and news. The platform allows users to search legislation, evaluate product compliance against different standards, and set up alerts on regulatory changes or safety issues. Its key features include automated compliance checks of formulas against limits, integrated regulatory data in new product development processes, and classification of food news and alerts.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
Product traceability and food safety (15 oct08)ECR Community
The document discusses issues around consumer trust in food and consumer products due to contamination issues and misleading health claims. It argues that establishing full traceability systems across supply chains can help rebuild consumer trust by enabling companies to track products, isolate risks, and credibly support product claims. However, current traceability systems have gaps, and a virtual traceability ecosystem is needed to realize the full benefits of traceability.
As a very critical industry for the health and well-being of people all over the world, the global food industry is subject to a vast amount of regulations throughout the global supply chain. With ongoing technical progress in automation and data processing, regulations will not only continue to grow, but will also demand more and more input from all participants in the supply chain. To achieve compliance with growing global regulations, it will become necessary
to provide fully traceable evidence about all supply chain movements from raw materials to the finished product. Looking beyond regulations, having full transparency and control over your supply chain can also result in fundamental advantages over the competition. If the available data is used properly, it can be harnessed and leveraged to gain a strategic business advantage including improvements in the overall supply chain procedures and a boost in customer trust and confidence by providing transparency about food origins.
Now is the time to take action and evolve your supply chain strategy...
Now is the time to move beyond simply meeting the minimum expectations of regulatory guidelines and evolve to a more strategic approach to complete supply chain integrity...
Now is the time to keep your company out of the headlines because of a recall or compromised link in your extended supply chain...
TGA presentation: Update on recent activitiesTGA Australia
This document provides an update on recent activities and ongoing reforms from the Scientific Evaluation Branch of the Therapeutic Goods Administration of Australia. It discusses implemented reforms such as streamlined variations for prescription medicines, utilizing evaluation reports from comparable overseas regulators, and biological and biosimilar medicines naming. Upcoming reforms addressed include improved labeling of neuromuscular blocking agents and regulation of fecal microbiota transplantation material. Approval times for different categories of medicines over the past years are also presented.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
This document discusses preparing for the upcoming EU Medical Device Regulation (MDR), which aims to improve patient safety but remains incomplete. It outlines an agenda including introductions, a discussion of MDR's likely impact on clinical evidence, transparency, and traceability, and common CEO questions. The discussion covers basic compliance questions companies should consider, mapping a compliance plan over the transition period, and notes that companies should start preparing now rather than waiting for full clarity.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
Presentation: Risk minimisation in the Australian contextTGA Australia
This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)
Safer Technologies Program for Medical DevicesEMMAIntl
FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available options that treat diseases that are non-life threatening...
What the FDA’s May 2021 Report on Foodborne Illness in Retail Delis RevealsSafetyChain Software
Dr. Rolando González from TAG unpacks the recent FDA recent report on foodborne illness in retail delis. Regardless of whether you are responsible for food safety in a deli located in a retail store or work in another manufacturing setting, attend!
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
Aegate Symposium Frankfurt June 2015 - Jan saevelsAegate
The APB, Belgium's national pharmacy association, has partnered with Aegate for 7 years to enhance patient safety through their serialization and traceability system. Aegate provides real-time recall warnings, expiration alerts, and counseling messages to pharmacists at the point of dispensing. This integration has helped APB efficiently manage recalls, prevent expired medications from being dispensed, and ensure important product information reaches pharmacists and patients. The Aegate-APB partnership has strengthened pharmacovigilance in Belgium through swift investigation and resolution of issues like a batch labeling error.
Synthetic biology is a novel field that finds its origin at the intersection of biology and engineering. It involves designing and construction of biological systems or devices that can be applied in varied domains to get specified results. It’s a multidisciplinary effort made by scientists to understand the functioning of biological organisms, cells & genes and implementation of artificial genetic processes to give specific characteristics to an organism.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
Aegate Symposium Frankfurt June 2015 - Graham commercial publishAegate
The document discusses Aegate's role in providing services related to the European Union's Falsified Medicines Directive. It outlines Aegate's selection to provide national blueprint systems for verification across Europe. It invites partners to join Aegate's ecosystem partner programme to gain access to information, best practices, and opportunities to benefit from Aegate's revenue sharing and certification programmes for pharmacies and software providers across Europe.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
Regulatory Compliance in the Pharmaceutical Supply ChainAudioEducator
The document summarizes key points about regulatory compliance in the pharmaceutical supply chain. It discusses how the FDA launched initiatives in 2002 to modernize drug manufacturing regulations using modern risk management and quality techniques. This was driven by an increase in adverse drug events and recalls. The FDA introduced new GMP regulations for the 21st century requiring comprehensive patient risk management and manufacturing approaches based on scientific principles. The new regulations can consider all products at a facility "adulterated" if any GMP system fails inspection, potentially wiping out revenue from a single high-risk product. The presentation provides background on these changes to FDA regulation and their impact on the pharmaceutical industry.
Tools Available to the FDA to Assess Patient SafetyEMMAIntl
Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients...
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
Managing Regulatory Compliance and Food safety With Cloud Data Supervision-Ch...Simba Events
The document discusses Selerant's Compliance Cloud, a cloud-based platform that helps companies manage regulatory compliance and food safety. It provides structured databases of food legislation limits from over 700,000 records across 200 countries. It also monitors food alerts, recalls and news. The platform allows users to search legislation, evaluate product compliance against different standards, and set up alerts on regulatory changes or safety issues. Its key features include automated compliance checks of formulas against limits, integrated regulatory data in new product development processes, and classification of food news and alerts.
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
Product traceability and food safety (15 oct08)ECR Community
The document discusses issues around consumer trust in food and consumer products due to contamination issues and misleading health claims. It argues that establishing full traceability systems across supply chains can help rebuild consumer trust by enabling companies to track products, isolate risks, and credibly support product claims. However, current traceability systems have gaps, and a virtual traceability ecosystem is needed to realize the full benefits of traceability.
As a very critical industry for the health and well-being of people all over the world, the global food industry is subject to a vast amount of regulations throughout the global supply chain. With ongoing technical progress in automation and data processing, regulations will not only continue to grow, but will also demand more and more input from all participants in the supply chain. To achieve compliance with growing global regulations, it will become necessary
to provide fully traceable evidence about all supply chain movements from raw materials to the finished product. Looking beyond regulations, having full transparency and control over your supply chain can also result in fundamental advantages over the competition. If the available data is used properly, it can be harnessed and leveraged to gain a strategic business advantage including improvements in the overall supply chain procedures and a boost in customer trust and confidence by providing transparency about food origins.
Now is the time to take action and evolve your supply chain strategy...
Now is the time to move beyond simply meeting the minimum expectations of regulatory guidelines and evolve to a more strategic approach to complete supply chain integrity...
Now is the time to keep your company out of the headlines because of a recall or compromised link in your extended supply chain...
Blockchain technology has the potential to address issues in fresh produce supply chains such as food safety, traceability, and cost. The document analyzes opportunities for and factors influencing the adoption of blockchain in fresh produce supply chains through a literature review and interviews with industry stakeholders and consumers. Key findings include that retailers and consumer concerns around food safety drive interest in blockchain, while costs and compatibility with existing systems present barriers. Widespread adoption will require further studies on how blockchain contributes commercial and trust benefits across the supply chain.
Preparing for New FSMA Preventive Controls RegulationsAlchemy Systems
FDA's current deadline for publishing the final rules for preventative controls for is quickly approaching. Find out what your company needs to know to prepare for these new regulatory requirements for FDA-regulated processors. This presentation provides an overview of preventative controls requirements under the Food Safety Modernization Act (FSMA), what is HARPC, and how to make the HACCP to HARPC conversion, as well as reassessing food safety plans for compliance and effectiveness.
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
This document summarizes a town hall meeting discussing the certification of personal health records (PHRs) by the Certification Commission for Healthcare Information Technology (CCHIT). It outlines the benefits of PHRs, why certification is important, what criteria will be used, and how the public can provide input. The key points are:
1) PHRs allow individuals to access and control their health information in one place to improve care and decision making.
2) CCHIT will begin certifying PHRs in July 2009 based on criteria for privacy, security, interoperability, and functionality.
3) The public is invited to comment on the draft PHR certification criteria through October 29, 2008 to help
The document discusses how automated systems can help improve food safety in the processing industry. It notes that while automation has increased production efficiency, there have still been many food safety failures. An automated food safety management system could help companies by standardizing procedures, improving traceability and transparency throughout the supply chain, enabling real-time trend analysis across all processes and products, and reducing risks and costs from failures and recalls. Implementing automated systems that track errors, schedule audits, and analyze data could help address current inefficiencies and systemic problems in ensuring food safety.
Learn the disconnect between regulatory traceability requirements & industry standards; how KDEs needed for recall resolution compare to those in FSMA 204; & ways to fortify your traceability system
Learn how to be prepared for product recalls within the food and beverage industry to help minimize potential damages. A food safety consultant and 20+ year USDA Food Safety Inspection Service (FSIS) veteran provides an inside view into what food safety inspectors focus on during a recall as follows:
1. Immediate proof that the contaminant is independent.
2. How much is in the supply chain and what is the worse-case scenario without proof.
3. Lot tracking records to determine what has been contaminated versus what has not.
At the end of the presentation watch the video of the webinar: 3 Things Food Safety Inspectors Focus on During a Recall.
Data integrity - Regulatory Perspective and Challenges: santoshnarla
This document provides an agenda for a conference on ensuring product quality and patient safety. The agenda includes sessions on data integrity risk management, data integrity in clinical research, data quality management in clinical research, regulations impacting data integrity, creating a culture of quality for data integrity, data management perspectives and challenges for the pharmaceutical MSME sector in India, data integrity from an analytical laboratory perspective, an overview of data integrity non-conformances from regulators, data integrity as an essential part of quality, the regulatory perspective on data integrity and challenges, MHRA and US FDA requirements for data integrity in clinical studies, data integrity on the manufacturing floor, and other topics. Various experts from the pharmaceutical industry will speak in the different sessions.
The document discusses problems with current medical device labeling and proposes solutions using a standardized labeling format. It describes initiatives by the FDA to address inconsistent labeling across companies by implementing standardized content sections and a centralized repository. The use of UDI and structured product labeling (SPL) formats could provide a consistent way to access up-to-date device information electronically through electronic health records. This would help patients and clinicians more easily obtain the right documentation for devices.
The Need-to-Haves, Nice-to-Haves, and Benefits of Supply Chain TraceabilitySafetyChain Software
Watch the replay here: https://info.safetychain.com/needs-benefits-supply-chain-traceability
Since the final FSMA 204 rule was established in late 2022, food manufacturers have been looking into what they'll need to meet the requirements before the deadline.
In this presentation we explored the effects of FSMA 204 food traceability methods and import rules, the impact to domestic and foreign suppliers, and the many potential benefits data tracking has to keep consumers healthy while driving down costs.
Food and Beverage Manufacturers, Producers, and Suppliers will learn:
• What's needed to strengthen food safety systems for effective data gathering
• How data tracing can lead to increased cost savings and productivity
• Where the Food Traceability List (FTL) is changing hazard management
• How to manage a culture of food safety to help maintain traceability and food safety FSMA requirements
Presented by Dr. Liliana Casal-Wardle | Executive Sr. Director, Food Safety @ The Acheson Group
Global food traceability market (tracking technologies) to reach $14.1 billio...Lita Person
The Food traceability (tracking technologies) market is growing at a healthy rate with increasing awareness about food safety among governments and consumers. Governments across the globe are making regulations to track food as it is directly concerned with consumer health.
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance
This webinar discusses IDMP (Identification of Medicinal Products) and focuses on substances and their implementation. It provides background on IDMP, timelines for implementation in the EU which is driving standardization, and an example substance record for Brentuximab Vedotin to illustrate the level of detail in substance definitions. The goal of IDMP is to improve patient safety through standardized identification and exchange of information on medicines and ingredients.
The presentation talks about the use of emerging technology i.e. IOT in Pharma Logistics.
The presentation talks about challenges faced by Pharma industry, and few success stories where IOT has provided feasible solutions.
It also talks about the future trends in Pharma Logistics, and touch base on Blockchains.
Optimizing management of clinical trial supply chains through improved visibi...SPLY ApS
Introduction slides for the workshop on best practice for optimizing the clinical supply chain visibility held at the Clinical Trials Supply Forum 2018 conference in London.
This document analyzes scientific studies on private sector engagement in food system transformations. It aims to assess study quality, analyze impact pathways, understand how private activities influence food systems, and identify success/failure factors. The approach includes conceptualization, literature review/screening, and case study analysis. The literature finds that business innovation, supply chain relationships, and governance regimes influence performance. A typology is proposed categorizing private sector roles. Public policies can support private sector engagement through price incentives, market transparency, reputation building, accreditation, and legal rules.
The document discusses challenges in the life sciences industry related to drug and device labeling including rising costs, global compliance, and risk of medication errors. It then introduces PRISYM Life Science software as a labeling solution that provides full compliance, security, validation support, and integration capabilities to address these challenges. Key features of PRISYM Life Science include being purpose-built for GMP compliance, secure electronic records, customization options, and use across the product development lifecycle from clinical trials to distribution.
New technologies such as the Internet of Things and Cloud Computing are expected to leverage the current
trend of Smart Farming, introducing more sensors, robots and artificial intelligence, encompassed by the
phenomenon of Big Data.
This presentation will give a quick insight into the state-of-the-art of Big Data applications in Smart Farming
and identify the related challenges that have to be addressed. It shows that the scope of Big Data
applications in Smart Farming goes beyond the farm; it is influencing the entire food supply chain. Big data
are being used to provide predictive insights in farming operations, drive real-time operational decisions, and
redesign business processes for game-changing business models.
It is expected that Big Data will cause major shifts in roles and power relations among different players in
current food supply chain networks. The landscape of stakeholders exhibits an interesting game between
powerful tech companies, venture capitalists and often small startups and new entrants. At the same time
there are several public institutions that publish open data, under the condition that the privacy of persons
must be guaranteed. The future of Smart Farming may unravel in a continuum of two extreme scenarios: 1)
closed, proprietary systems or 2) open, collaborative systems.
The development of data and application infrastructures (platforms and standards) and their institutional
embedment will play a crucial role in the battle between these scenarios. A major challenge is therefore to
cope with governance issues and define suitable business models for data sharing in different supply chain
scenarios.
Similar to Jennifer McEntire Presentation to FDA (20)
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
In the rapidly evolving landscape of technologies, XML continues to play a vital role in structuring, storing, and transporting data across diverse systems. The recent advancements in artificial intelligence (AI) present new methodologies for enhancing XML development workflows, introducing efficiency, automation, and intelligent capabilities. This presentation will outline the scope and perspective of utilizing AI in XML development. The potential benefits and the possible pitfalls will be highlighted, providing a balanced view of the subject.
We will explore the capabilities of AI in understanding XML markup languages and autonomously creating structured XML content. Additionally, we will examine the capacity of AI to enrich plain text with appropriate XML markup. Practical examples and methodological guidelines will be provided to elucidate how AI can be effectively prompted to interpret and generate accurate XML markup.
Further emphasis will be placed on the role of AI in developing XSLT, or schemas such as XSD and Schematron. We will address the techniques and strategies adopted to create prompts for generating code, explaining code, or refactoring the code, and the results achieved.
The discussion will extend to how AI can be used to transform XML content. In particular, the focus will be on the use of AI XPath extension functions in XSLT, Schematron, Schematron Quick Fixes, or for XML content refactoring.
The presentation aims to deliver a comprehensive overview of AI usage in XML development, providing attendees with the necessary knowledge to make informed decisions. Whether you’re at the early stages of adopting AI or considering integrating it in advanced XML development, this presentation will cover all levels of expertise.
By highlighting the potential advantages and challenges of integrating AI with XML development tools and languages, the presentation seeks to inspire thoughtful conversation around the future of XML development. We’ll not only delve into the technical aspects of AI-powered XML development but also discuss practical implications and possible future directions.
Threats to mobile devices are more prevalent and increasing in scope and complexity. Users of mobile devices desire to take full advantage of the features
available on those devices, but many of the features provide convenience and capability but sacrifice security. This best practices guide outlines steps the users can take to better protect personal devices and information.
Programming Foundation Models with DSPy - Meetup SlidesZilliz
Prompting language models is hard, while programming language models is easy. In this talk, I will discuss the state-of-the-art framework DSPy for programming foundation models with its powerful optimizers and runtime constraint system.
Best 20 SEO Techniques To Improve Website Visibility In SERPPixlogix Infotech
Boost your website's visibility with proven SEO techniques! Our latest blog dives into essential strategies to enhance your online presence, increase traffic, and rank higher on search engines. From keyword optimization to quality content creation, learn how to make your site stand out in the crowded digital landscape. Discover actionable tips and expert insights to elevate your SEO game.
Full-RAG: A modern architecture for hyper-personalizationZilliz
Mike Del Balso, CEO & Co-Founder at Tecton, presents "Full RAG," a novel approach to AI recommendation systems, aiming to push beyond the limitations of traditional models through a deep integration of contextual insights and real-time data, leveraging the Retrieval-Augmented Generation architecture. This talk will outline Full RAG's potential to significantly enhance personalization, address engineering challenges such as data management and model training, and introduce data enrichment with reranking as a key solution. Attendees will gain crucial insights into the importance of hyperpersonalization in AI, the capabilities of Full RAG for advanced personalization, and strategies for managing complex data integrations for deploying cutting-edge AI solutions.
For the full video of this presentation, please visit: https://www.edge-ai-vision.com/2024/06/building-and-scaling-ai-applications-with-the-nx-ai-manager-a-presentation-from-network-optix/
Robin van Emden, Senior Director of Data Science at Network Optix, presents the “Building and Scaling AI Applications with the Nx AI Manager,” tutorial at the May 2024 Embedded Vision Summit.
In this presentation, van Emden covers the basics of scaling edge AI solutions using the Nx tool kit. He emphasizes the process of developing AI models and deploying them globally. He also showcases the conversion of AI models and the creation of effective edge AI pipelines, with a focus on pre-processing, model conversion, selecting the appropriate inference engine for the target hardware and post-processing.
van Emden shows how Nx can simplify the developer’s life and facilitate a rapid transition from concept to production-ready applications.He provides valuable insights into developing scalable and efficient edge AI solutions, with a strong focus on practical implementation.
Building Production Ready Search Pipelines with Spark and MilvusZilliz
Spark is the widely used ETL tool for processing, indexing and ingesting data to serving stack for search. Milvus is the production-ready open-source vector database. In this talk we will show how to use Spark to process unstructured data to extract vector representations, and push the vectors to Milvus vector database for search serving.
HCL Notes and Domino License Cost Reduction in the World of DLAUpanagenda
Webinar Recording: https://www.panagenda.com/webinars/hcl-notes-and-domino-license-cost-reduction-in-the-world-of-dlau/
The introduction of DLAU and the CCB & CCX licensing model caused quite a stir in the HCL community. As a Notes and Domino customer, you may have faced challenges with unexpected user counts and license costs. You probably have questions on how this new licensing approach works and how to benefit from it. Most importantly, you likely have budget constraints and want to save money where possible. Don’t worry, we can help with all of this!
We’ll show you how to fix common misconfigurations that cause higher-than-expected user counts, and how to identify accounts which you can deactivate to save money. There are also frequent patterns that can cause unnecessary cost, like using a person document instead of a mail-in for shared mailboxes. We’ll provide examples and solutions for those as well. And naturally we’ll explain the new licensing model.
Join HCL Ambassador Marc Thomas in this webinar with a special guest appearance from Franz Walder. It will give you the tools and know-how to stay on top of what is going on with Domino licensing. You will be able lower your cost through an optimized configuration and keep it low going forward.
These topics will be covered
- Reducing license cost by finding and fixing misconfigurations and superfluous accounts
- How do CCB and CCX licenses really work?
- Understanding the DLAU tool and how to best utilize it
- Tips for common problem areas, like team mailboxes, functional/test users, etc
- Practical examples and best practices to implement right away
UiPath Test Automation using UiPath Test Suite series, part 6DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 6. In this session, we will cover Test Automation with generative AI and Open AI.
UiPath Test Automation with generative AI and Open AI webinar offers an in-depth exploration of leveraging cutting-edge technologies for test automation within the UiPath platform. Attendees will delve into the integration of generative AI, a test automation solution, with Open AI advanced natural language processing capabilities.
Throughout the session, participants will discover how this synergy empowers testers to automate repetitive tasks, enhance testing accuracy, and expedite the software testing life cycle. Topics covered include the seamless integration process, practical use cases, and the benefits of harnessing AI-driven automation for UiPath testing initiatives. By attending this webinar, testers, and automation professionals can gain valuable insights into harnessing the power of AI to optimize their test automation workflows within the UiPath ecosystem, ultimately driving efficiency and quality in software development processes.
What will you get from this session?
1. Insights into integrating generative AI.
2. Understanding how this integration enhances test automation within the UiPath platform
3. Practical demonstrations
4. Exploration of real-world use cases illustrating the benefits of AI-driven test automation for UiPath
Topics covered:
What is generative AI
Test Automation with generative AI and Open AI.
UiPath integration with generative AI
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Why You Should Replace Windows 11 with Nitrux Linux 3.5.0 for enhanced perfor...SOFTTECHHUB
The choice of an operating system plays a pivotal role in shaping our computing experience. For decades, Microsoft's Windows has dominated the market, offering a familiar and widely adopted platform for personal and professional use. However, as technological advancements continue to push the boundaries of innovation, alternative operating systems have emerged, challenging the status quo and offering users a fresh perspective on computing.
One such alternative that has garnered significant attention and acclaim is Nitrux Linux 3.5.0, a sleek, powerful, and user-friendly Linux distribution that promises to redefine the way we interact with our devices. With its focus on performance, security, and customization, Nitrux Linux presents a compelling case for those seeking to break free from the constraints of proprietary software and embrace the freedom and flexibility of open-source computing.
Unlocking Productivity: Leveraging the Potential of Copilot in Microsoft 365, a presentation by Christoforos Vlachos, Senior Solutions Manager – Modern Workplace, Uni Systems
Infrastructure Challenges in Scaling RAG with Custom AI modelsZilliz
Building Retrieval-Augmented Generation (RAG) systems with open-source and custom AI models is a complex task. This talk explores the challenges in productionizing RAG systems, including retrieval performance, response synthesis, and evaluation. We’ll discuss how to leverage open-source models like text embeddings, language models, and custom fine-tuned models to enhance RAG performance. Additionally, we’ll cover how BentoML can help orchestrate and scale these AI components efficiently, ensuring seamless deployment and management of RAG systems in the cloud.
20240609 QFM020 Irresponsible AI Reading List May 2024
Jennifer McEntire Presentation to FDA
1. December 10, 2009 Jennifer McEntire, Ph.D. IFT Research Scientist and Manager, Science and Technology Projects Product Tracing in Food Systems An IFT report to the FDA