The document summarizes the ComplianceOnline Medical Device Summit that will take place March 19-20, 2015 in San Diego, CA. ComplianceOnline has extensive experience conducting regulatory compliance trainings and this summit will bring together medical device industry experts, professionals, and executives to discuss challenges facing the industry such as new regulations, cybersecurity threats, technological advances, and lawsuits. The summit will include keynote speeches, panel discussions, workshops, and an expo. It aims to help professionals stay up-to-date on industry issues and network with their peers.
This document provides an overview of ROW2 Technologies and their SmartChem database. It discusses ROW2's expertise in synthetic organic chemistry and their global knowledge base. The document demonstrates SmartChem's features like showing reaction schemes and allowing users to obtain quotes from multiple suppliers with one click. It provides details on SmartChem's data coverage, search options, and upcoming features. Testimonials are also included that praise SmartChem's usefulness and ROW2's customer service.
Computer Aided Drafting (CAD) is the process of constructing drawings on a computer screen using specialized software and hardware. Common CAD software packages include AutoCAD, Pro/ENGINEER, NX Unigraphics, and SOLIDWORKS. CAD offers advantages like accuracy, speed, easy editing, space effectiveness through digital storage, standard part libraries, scaling, better visualization, and not requiring physical drawing tools. Main components of CAD software include title bars, menu bars, tool bars, status bars, command windows, and document windows. Common commands are used for drawing, editing, dimensioning, and 3D modeling in CAD.
The WIP Foundation aims to enhance global pain management through education, research, and training. It will facilitate teaching pain management worldwide, with emphasis on developing countries. The Foundation will support physician education and certification programs, create a global pain incidence database, and promote research collaborations. Donations will fund scholarships, conference attendance, and certification for physicians worldwide to improve access to pain treatment expertise.
This curriculum vitae summarizes the educational and professional background of Dr. James D. Ponzi. He has obtained multiple degrees including a Doctorate in Business Administration with a specialization in Homeland Security Management. Dr. Ponzi has over 35 years of experience in law enforcement, including serving as a Lieutenant for the Denver Police Department. He is currently an Assistant Professor and Lead Faculty for Criminology at Regis University, where he has taught courses in criminology, cybercrime, and criminal profiling.
This document provides an overview of ROW2 Technologies and their SmartChem database. It discusses ROW2's expertise in synthetic organic chemistry and their global knowledge base. The document demonstrates SmartChem's features like showing reaction schemes and allowing users to obtain quotes from multiple suppliers with one click. It provides details on SmartChem's data coverage, search options, and upcoming features. Testimonials are also included that praise SmartChem's usefulness and ROW2's customer service.
Computer Aided Drafting (CAD) is the process of constructing drawings on a computer screen using specialized software and hardware. Common CAD software packages include AutoCAD, Pro/ENGINEER, NX Unigraphics, and SOLIDWORKS. CAD offers advantages like accuracy, speed, easy editing, space effectiveness through digital storage, standard part libraries, scaling, better visualization, and not requiring physical drawing tools. Main components of CAD software include title bars, menu bars, tool bars, status bars, command windows, and document windows. Common commands are used for drawing, editing, dimensioning, and 3D modeling in CAD.
The WIP Foundation aims to enhance global pain management through education, research, and training. It will facilitate teaching pain management worldwide, with emphasis on developing countries. The Foundation will support physician education and certification programs, create a global pain incidence database, and promote research collaborations. Donations will fund scholarships, conference attendance, and certification for physicians worldwide to improve access to pain treatment expertise.
This curriculum vitae summarizes the educational and professional background of Dr. James D. Ponzi. He has obtained multiple degrees including a Doctorate in Business Administration with a specialization in Homeland Security Management. Dr. Ponzi has over 35 years of experience in law enforcement, including serving as a Lieutenant for the Denver Police Department. He is currently an Assistant Professor and Lead Faculty for Criminology at Regis University, where he has taught courses in criminology, cybercrime, and criminal profiling.
Point-To-Point excels at engaging broadcast audiences. To do that, we must have the highest quality, best strategies, and most innovative techniques. Whether direct mail, telemarketing, or interactive components, it is all about getting the message from you to your prospects. We never hesitate to use the best and most experienced people behind the scenes.
The document provides solutions to homework problems involving queueing models. Key points include:
- Adding a second tool crib attendant reduces costs from $55 to $33.09 per hour.
- The maximum arrival rate for a single-runway airport is 4/9 planes per hour to keep wait times below 3 minutes.
- The expected number of ships waiting at the Port of Trop is 1.735.
This case involves a 7-year-old female presenting with acute renal failure, facial swelling, and hematuria. She had been treated for malaria and pneumonia in the past month. Her creatinine was elevated at 1711 umol/L, indicating severe acute renal injury. Possible causes of her acute renal failure include an allergic reaction to antibiotics like gentamicin or cephalosporins, or nephrotoxicity from multiple antibiotic exposures over the past month. Her renal failure should be managed by discontinuing any nephrotoxic medications, aggressive hydration, and monitoring of her renal function.
This document provides information about Softjourn, a software engineering company with offices in Ukraine and Poland. Softjourn offers application development and quality assurance services. They have over 300 completed projects and a team of over 140 software engineers and testers. Softjourn recruits top talent from local universities and has internship programs to bring in new talent. They utilize agile methodologies and tools like Git for version control and Jira for bug tracking on projects.
Softjourn has developed mobile applications for various clients across different platforms including iPhone, iPad, Android and Windows Phone 7. They have created apps for ticketing, social networks, magazines, games, banking, and more. Their experience includes both native and browser-based applications. Companies choose Softjourn for their reputation in on-time and on-budget deliveries of high quality work.
1) A 2-year-old male child, KW, was admitted with a 3-day history of cough but no difficulty breathing, fever, or other symptoms.
2) On examination, KW had an increased respiratory rate of 70 bpm and abnormal bloodwork. He was diagnosed with bronchopneumonia.
3) KW's treatment plan included intravenous ampicillin, gentamicin, and hydrocortisone for 5 days to treat the bronchopneumonia. By day 2, his symptoms had improved and he was continuing on the antibiotic treatment plan with the goal of discharging him on oral amoxicillin.
The document outlines four strategies for a tourism company to exceed sales quotas: 1) exceed quotas by making a minimum number of sales contacts each week, 2) increase marketplace awareness through professional associations, trade shows, and articles, 3) increase community awareness through networking and volunteering, and 4) obtain referrals from new customers. It also describes strategies for existing customers, including a touchpoint program and prospecting within current accounts. The key is to create a sales plan with weekly tactics, regularly review and revise the plan, and stay on track to meet quotas.
The document discusses eCommerce in the travel industry. It begins with definitions of key terms like the world wide web, eBusiness, and eCommerce. It then explains the importance of eCommerce, highlighting growth in online travel markets and tour operators shifting focus to eCommerce. The types of eCommerce are described, including B2B, B2C, C2B, C2C. It outlines how eCommerce works and the advantages and disadvantages. Finally, it provides guidance on how travel companies can establish an eCommerce presence, including building yield teams, customizing services, and ensuring competitiveness on websites.
This document discusses several challenges related to managing and sharing genomic and biomedical data. It identifies key issues such as data annotation, analysis, storage, sharing, long-term planning, funding, and making data available in public repositories. It also discusses the importance of metadata, using ontologies and standards, developing data sharing policies that meet funder and journal requirements, and ensuring data is processed ethically and securely in accordance with privacy regulations.
This document discusses several challenges related to managing and sharing genomic and metagenomic data, including issues around annotation, storage, analysis, funding, and metadata. It provides examples of resources for data submission, annotation, visualization, and analysis. Ensuring interoperability through the use of ontologies and standards is important. Proper documentation through metadata adds value to data sets and enables future analysis and rediscovery. Careful planning around data management and sharing is needed from the early stages of a project through the long-term preservation of data.
This document discusses data accessibility and challenges. It covers the data life cycle, including planning, generating data, reliability, ownership, metadata, versioning, and publishing. It discusses expectations for accessing and sharing data. Open access data policies are encouraged by research funders, journals, and initiatives like DataCite to assign identifiers to research data. Data can be shared through repositories, journals, websites, or informally between researchers. Factors that affect sharing and accessing data include size, computing needs, standards, repositories, data nature, governance, and metadata.
The document announces a two-day in-person seminar on preparing for and responding to FDA inspections. The seminar will be held on July 21st and 22nd, 2016 in Cape Town, South Africa and led by regulatory expert David Dills. It will provide fundamentals and best practices for interacting with inspectors, ensuring documentation is in order, responding to inspection findings, and achieving favorable outcomes. Topics include inspection preparation and training, documentation requirements, dos and don'ts for interacting with investigators, and following up after inspections.
Implementing MDSAP (Medical Device Single Audit Program) for Compliance SuccessGlobalCompliancePanel
Reviewing the most significant changes affecting medical device standards and guidance documents, Understanding the MDSAP (goals and strategy), Analyzing the MDSAP main differences with standard auditing, Understanding grading of MDSAP non-conformances
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
why FDA at my Facility is, and what do I do During an InspectionGlobalCompliancePanel
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arr...marcus evans Network
The medical device industry is facing increased challenges such as cost constraints, decreased spending, and new regulations. Paul Arrendell advises that companies must promote a culture of quality by understanding regulations, validating processes, making quality decisions, and integrating quality throughout the business. He discusses seven strategies for building a quality culture, including design and reliability engineering, robust post-production monitoring, supplier management, quality metrics, incorporating quality into roles and incentives, and learning from other companies' mistakes. Arrendell was speaking at the marcus evans Medical Device Manufacturing and R&D Summits in June 2014.
This document provides an agenda and information for the Partnerships in Clinical Trials conference taking place November 17-19, 2015 in Hamburg, Germany. The conference will focus on key topics in clinical trials including risk-based monitoring, patient centricity, innovation, and partnerships. It outlines the schedule, speakers, and session topics over the three days. Some highlights include workshops on outsourcing strategies, leadership, and risk-based monitoring on November 17th, and keynotes on the evolving partnership landscape, TransCelerate progress, and a patient perspective on November 18-19th. The agenda provides details on over 120 speakers and 8 streams of concurrent sessions on issues important to the clinical trials industry.
Point-To-Point excels at engaging broadcast audiences. To do that, we must have the highest quality, best strategies, and most innovative techniques. Whether direct mail, telemarketing, or interactive components, it is all about getting the message from you to your prospects. We never hesitate to use the best and most experienced people behind the scenes.
The document provides solutions to homework problems involving queueing models. Key points include:
- Adding a second tool crib attendant reduces costs from $55 to $33.09 per hour.
- The maximum arrival rate for a single-runway airport is 4/9 planes per hour to keep wait times below 3 minutes.
- The expected number of ships waiting at the Port of Trop is 1.735.
This case involves a 7-year-old female presenting with acute renal failure, facial swelling, and hematuria. She had been treated for malaria and pneumonia in the past month. Her creatinine was elevated at 1711 umol/L, indicating severe acute renal injury. Possible causes of her acute renal failure include an allergic reaction to antibiotics like gentamicin or cephalosporins, or nephrotoxicity from multiple antibiotic exposures over the past month. Her renal failure should be managed by discontinuing any nephrotoxic medications, aggressive hydration, and monitoring of her renal function.
This document provides information about Softjourn, a software engineering company with offices in Ukraine and Poland. Softjourn offers application development and quality assurance services. They have over 300 completed projects and a team of over 140 software engineers and testers. Softjourn recruits top talent from local universities and has internship programs to bring in new talent. They utilize agile methodologies and tools like Git for version control and Jira for bug tracking on projects.
Softjourn has developed mobile applications for various clients across different platforms including iPhone, iPad, Android and Windows Phone 7. They have created apps for ticketing, social networks, magazines, games, banking, and more. Their experience includes both native and browser-based applications. Companies choose Softjourn for their reputation in on-time and on-budget deliveries of high quality work.
1) A 2-year-old male child, KW, was admitted with a 3-day history of cough but no difficulty breathing, fever, or other symptoms.
2) On examination, KW had an increased respiratory rate of 70 bpm and abnormal bloodwork. He was diagnosed with bronchopneumonia.
3) KW's treatment plan included intravenous ampicillin, gentamicin, and hydrocortisone for 5 days to treat the bronchopneumonia. By day 2, his symptoms had improved and he was continuing on the antibiotic treatment plan with the goal of discharging him on oral amoxicillin.
The document outlines four strategies for a tourism company to exceed sales quotas: 1) exceed quotas by making a minimum number of sales contacts each week, 2) increase marketplace awareness through professional associations, trade shows, and articles, 3) increase community awareness through networking and volunteering, and 4) obtain referrals from new customers. It also describes strategies for existing customers, including a touchpoint program and prospecting within current accounts. The key is to create a sales plan with weekly tactics, regularly review and revise the plan, and stay on track to meet quotas.
The document discusses eCommerce in the travel industry. It begins with definitions of key terms like the world wide web, eBusiness, and eCommerce. It then explains the importance of eCommerce, highlighting growth in online travel markets and tour operators shifting focus to eCommerce. The types of eCommerce are described, including B2B, B2C, C2B, C2C. It outlines how eCommerce works and the advantages and disadvantages. Finally, it provides guidance on how travel companies can establish an eCommerce presence, including building yield teams, customizing services, and ensuring competitiveness on websites.
This document discusses several challenges related to managing and sharing genomic and biomedical data. It identifies key issues such as data annotation, analysis, storage, sharing, long-term planning, funding, and making data available in public repositories. It also discusses the importance of metadata, using ontologies and standards, developing data sharing policies that meet funder and journal requirements, and ensuring data is processed ethically and securely in accordance with privacy regulations.
This document discusses several challenges related to managing and sharing genomic and metagenomic data, including issues around annotation, storage, analysis, funding, and metadata. It provides examples of resources for data submission, annotation, visualization, and analysis. Ensuring interoperability through the use of ontologies and standards is important. Proper documentation through metadata adds value to data sets and enables future analysis and rediscovery. Careful planning around data management and sharing is needed from the early stages of a project through the long-term preservation of data.
This document discusses data accessibility and challenges. It covers the data life cycle, including planning, generating data, reliability, ownership, metadata, versioning, and publishing. It discusses expectations for accessing and sharing data. Open access data policies are encouraged by research funders, journals, and initiatives like DataCite to assign identifiers to research data. Data can be shared through repositories, journals, websites, or informally between researchers. Factors that affect sharing and accessing data include size, computing needs, standards, repositories, data nature, governance, and metadata.
The document announces a two-day in-person seminar on preparing for and responding to FDA inspections. The seminar will be held on July 21st and 22nd, 2016 in Cape Town, South Africa and led by regulatory expert David Dills. It will provide fundamentals and best practices for interacting with inspectors, ensuring documentation is in order, responding to inspection findings, and achieving favorable outcomes. Topics include inspection preparation and training, documentation requirements, dos and don'ts for interacting with investigators, and following up after inspections.
Implementing MDSAP (Medical Device Single Audit Program) for Compliance SuccessGlobalCompliancePanel
Reviewing the most significant changes affecting medical device standards and guidance documents, Understanding the MDSAP (goals and strategy), Analyzing the MDSAP main differences with standard auditing, Understanding grading of MDSAP non-conformances
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
why FDA at my Facility is, and what do I do During an InspectionGlobalCompliancePanel
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arr...marcus evans Network
The medical device industry is facing increased challenges such as cost constraints, decreased spending, and new regulations. Paul Arrendell advises that companies must promote a culture of quality by understanding regulations, validating processes, making quality decisions, and integrating quality throughout the business. He discusses seven strategies for building a quality culture, including design and reliability engineering, robust post-production monitoring, supplier management, quality metrics, incorporating quality into roles and incentives, and learning from other companies' mistakes. Arrendell was speaking at the marcus evans Medical Device Manufacturing and R&D Summits in June 2014.
This document provides an agenda and information for the Partnerships in Clinical Trials conference taking place November 17-19, 2015 in Hamburg, Germany. The conference will focus on key topics in clinical trials including risk-based monitoring, patient centricity, innovation, and partnerships. It outlines the schedule, speakers, and session topics over the three days. Some highlights include workshops on outsourcing strategies, leadership, and risk-based monitoring on November 17th, and keynotes on the evolving partnership landscape, TransCelerate progress, and a patient perspective on November 18-19th. The agenda provides details on over 120 speakers and 8 streams of concurrent sessions on issues important to the clinical trials industry.
the challenges of an effective change control program and how to address oos ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
Medical Coding and Billing Conference CodingCon OrlandoSuperCoder LLC
Join the most interactive specialty specific medical coding and billing conference i.e. codingcon 2015 set to take place on Dec 2-4 in Orlando, FL. Win FREE passes to attend the conference. Earn upto 18 CEUs.
Want to know more about upcoming codingCon 2015 just follow this link: https://goo.gl/Tsrl6B
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
This document provides the agenda for the Fall 2014 Consortium Members' Meeting. The agenda includes:
- Case studies from member organizations on their experiences implementing Consortium best practices and tools
- Updates on 2014 initiatives and progress executing projects
- Interactive sessions for members to provide feedback on new quality agreement templates and prequalification standards for technical service providers
- Discussion of potential focus areas and initiatives for 2015, including leveraging the Consortium for knowledge sharing and transforming quality practices
The 3rd Annual Global Pharmaceutical and Medical Meetings SummitWorldCongress
We are excited to announce the launch of the 3rd Annual Global Pharmaceutical and Medical Meetings Summit ™. The boutique-like Summit gathers senior pharmaceutical, biotech, medical device and healthcare meeting executives for empowering ROI-driven conversations about the industry’s biggest opportunities. Those conversations are amplified in a way no other event can be through ongoing networking and shared best practices.
As usual, World Congress commits to a 50/50 or better ratio of Meeting executive and Solution Providers.
The conference will provide insights into quality and systems thinking with a carefully planned program bridging theory to practice. Speakers from Shell, NASA, and the FDA will discuss transforming work processes for quality assurance due to new complexities from advances like the industrial internet. Attendees can learn directly from the experts on quality thinking and applying it in life sciences, healthcare, and other industries. The conference aims to help attendees prepare for the future of their work.
The Hitchhiker’s guide to 483s and warning lettersAnita Anzo
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
A fun way to present this serious topic !
Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA.
With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility.
483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection.
In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures.
Can you afford not to be prepared ?
This presentation will use humor to describe:
> Why the FDA issues such citations
> What is a 483 and what does it look like
> What is a Warning letter and what does it look like
> What is the difference between a 483 and a Warning Letter
> What they mean for your company
> How to respond to 483s and Warning Letters to avoid escalation by the FDA
> How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters
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LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
2024 HIPAA Compliance Training Guide to the Compliance OfficersConference Panel
Join us for a comprehensive 90-minute lesson designed specifically for Compliance Officers and Practice/Business Managers. This 2024 HIPAA Training session will guide you through the critical steps needed to ensure your practice is fully prepared for upcoming audits. Key updates and significant changes under the Omnibus Rule will be covered, along with the latest applicable updates for 2024.
Key Areas Covered:
Texting and Email Communication: Understand the compliance requirements for electronic communication.
Encryption Standards: Learn what is necessary and what is overhyped.
Medical Messaging and Voice Data: Ensure secure handling of sensitive information.
IT Risk Factors: Identify and mitigate risks related to your IT infrastructure.
Why Attend:
Expert Instructor: Brian Tuttle, with over 20 years in Health IT and Compliance Consulting, brings invaluable experience and knowledge, including insights from over 1000 risk assessments and direct dealings with Office of Civil Rights HIPAA auditors.
Actionable Insights: Receive practical advice on preparing for audits and avoiding common mistakes.
Clarity on Compliance: Clear up misconceptions and understand the reality of HIPAA regulations.
Ensure your compliance strategy is up-to-date and effective. Enroll now and be prepared for the 2024 HIPAA audits.
Enroll Now to secure your spot in this crucial training session and ensure your HIPAA compliance is robust and audit-ready.
https://conferencepanel.com/conference/hipaa-training-for-the-compliance-officer-2024-updates
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
We are one of the top Massage Spa Ajman Our highly skilled, experienced, and certified massage therapists from different corners of the world are committed to serving you with a soothing and relaxing experience. Luxuriate yourself at our spas in Sharjah and Ajman, which are indeed enriched with an ambiance of relaxation and tranquility. We could confidently claim that we are one of the most affordable Spa Ajman and Sharjah as well, where you can book the massage session of your choice for just 99 AED at any time as we are open 24 hours a day, 7 days a week.
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DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
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Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
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Interactive Q&A: Engage the audience and encourage discussion.
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TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
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Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
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Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
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Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
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Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
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Champions of Health Spotlight On Leaders Shaping Germany's Healthcare.pdf
Medical device-summit-2015-brochure
1. March 19-20, 2015, San Diego, CA
ComplianceOnline is a leading provider of regulatory compliance trainings for
companies and professionals in regulated industries. ComplianceOnline has
successfully trained over 35,000 professionals from 9,000 companies to comply with
the requirements of regulatory agencies.
ComplianceOnline has a strong, proven track record in conducting live, in-person
seminars and workshops to train professionals from industries such as life sciences,
health care, banking and financial services, manufacturing, software and more.
Building on this decade-long expertise, ComplianceOnline is conducting its first
Medical Device Summit this year in San Diego, CA.
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2. The medical device industry continues to
experience rapid growth rates. This success has
brought along with it a number of challenges
relating to quality, regulatory compliance,
technology, innovation, taxation, supply chain
management and more.
The ComplianceOnline Medical Device Summit
will provide a venue for industry experts,
professionals and executives to discuss and debate
these challenges as well as explore new strategies
and opportunities for growth. The event will also
be an exclusive business opportunity for medical
device companies – stalls will be available for
organizations to exhibit their latest products and
technological innovations. From a marketing and
branding perspective, the event provides
unrivalled and once-in-a-lifetime opportunity for
both established as well as up-and-coming
medical device companies and their suppliers.
The new Medical Device tax that is continuing
to prove controversial in the US and beyond
The increasing threats to patient safety and
company reputations because of cyber-attacks
The rapid changes in technology that can make
even a smartphone a medical device and the
legal/safety issues these bring
Recent product safety related lawsuits – how
will these influence the future direction of the
industry?
Supply chain management and third party
reliability remain major challenges for the
industry
The Event
An Industry Facing Major
Challenges
Issues that the Medical Device industry is
facing at present include:
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3. The ComplianceOnline Medical Device Summit will be one of the largest gatherings of medical device
companies, suppliers, professionals and experts in 2015.
This event gives professionals – whether they are new entrants in the field or middle management or veterans – to
interact with the leading minds in the industry about the current state of laws and technology and government
oversight and more. Professionals will get CPE credits after attending workshops and also get prime networking
opportunities with their industry peers from the across the US.
The discussions, debates, workshops and exhibitions will also throw light on the direction the industry will take in
the future – making it all the more important for today’s medical device professionals to actively take part in the
ComplianceOnline Medical Device Summit.
Why Attend This Event?
Post-Event Online Community
Exclusively only for the conference
attendees
A platform to discuss the latest and most
pressing issues affecting the global
medical device industry
A networking tool provided to all attendees
of this conference for continuous
networking opportunity.
Delegates will benefit from:
Focused multiple track workshops
Prime networking opportunities with your peers
from companies across USA
One-Stop-shop, inviting A-Z suppliers for
Med-Dev industry
Pre-Course Questionnaire to understand
individual’s needs
CPE credits on workshops
Post-Event Online Community access to stay in
touch with all other attendees
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4. Delegate package includes
1. Complete access to presentations, panel discussions, keynote sessions for 2 days
2. Full access to selected workshops
3. CPE credits (for approved workshops) and attendance certificate at the end of the program
4. Access to course materials
5. Access to networking luncheons and coffee breaks on both the days
6. Complimentary access to Post-Event Online Community
7. Discounts on seminars/webinars and other products worth $630.
Delegate Registration Details
$699No. Of Participants - 2
$599No. Of Participants - 3 & 3+
$799No. Of Participants - 1
*Above prices are for per attendee
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5. 2.40PM - 3.00PM 20 Mins Sponsor Speaking Opportunity2.40PM - 3.00PM 20 Mins Sponsor Speaking Opportunity
Agenda
Day One: Thursday, March 19, 2015
8.00AM - 9.00AM
9.10AM - 9.40AM
60 Mins Registration
9.00AM - 9.10AM 10 Mins Introduction - Welcome Speech with an introduction of ComplianceOnline & Summit
30 Mins
Inspirational Keynote - Growth & Opportunities 2020: Vision 2020 & Beyond
• Aging Population and threat to society
• Increase of direct pressure on MD industry as a sudden rise of healthcare services need
• MD for better life style
• Analyst Presentation - Political Changes
• Market volatility because of political changes
• Is Obamacare leading MD to Loss?
9.40AM - 10:30AM 50 Mins
Panel Discussion - Role & Market Evolution of USA
• World leader in MD Manufacturing (58% of Market Share)
• Top & Raising Global MD Markets for business: BRIC, EU, Japan, Korea, Latin America, Australia
10.30AM - 11.00AM 30 Mins
11.00AM - 11.20AM 20 Mins Networking Coffee/Tea Break
12:40PM - 2:00 PM 80 Mins LUNCH
11.20AM - 12.00PM 40 Mins Sponsors Speaking Opportunity
12.00PM - 12.40PM 40 Mins
Venture Investing -
Finding capital today is difficult no matter what the stage of the company. This panel of entrepreneurs and
CEOs will share their experiences in the search for capital.
• Understanding Corporate Investors and Buyers
• Changing Areas of Investor Interest investment
• Managing Your Patent Portfolio
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2.00PM - 2.40PM 40 Mins 2.00PM - 2.40PM 40 Mins
Track A - Sessions Track B - Sessions
**Track A is most suitable for Top Level executives from various
depts. However attendees of all levels can attend it.
**Track B is more suitable for Mid-Level Managers from
Compliance, Regulatory, Quality, Project Mgmt & R&D depts.
However attendees of all levels can attend it.
Mergers & Acquisitions
The M &A environment, for the medical device industry is constantly
changing. This round table discussion will bring together executives
and notable experience in the medical device industry and beyond.
The roundtable discussion will also focus on Meetings with
Stakeholders to identify opportunities and recommendations, Factors
which influence the value of M&A.
They Panelist have had numerous successes and consequent
failures: working with investors, selling and buying companies, and
starting all over again. They will be sharing their deep insights on
their Experiences, Following will be covered:
• How were their companies started and sold?
• What lessons were learned the hard way?
• What would they have done differently?
• Advice for the future?
Medical Device Recall and Compliant Management
Medical Device Reporting (MDR) and recall compliance are critical
to the continue survival of all device manufacturers. The FDA is
continuing their efforts to issue numerous FDA Warning Letters
and serious enforcement actions, including criminal & civil
penalties levied on companies that failed to properly report events
and take proper corrective and removal actions. The number of
device companies having their recall classified as a Class 1 (most
severe) recall has surged in the past three years. Additionally,
product liability and financial risks are staggering when companies
fail to properly report and take action when required.
This workshop will cover:
• FDA Expectations: Complaint System Inspections
• Medical Device Reporting (MDR)
• Workshop: Complaints vs. MDRs...is it or isn't it reportable?!
• Corrective & Preventive Action System (CAPA)
• FDA's Medical Device Recall Process
• How Industry Should Handle Recalls
[Cont...]
The 21st century FDA - Help or hindrance to innovation
Many blame the FDA for being a sea anchor to medical innovation? But is that simply urban mythology? With
new regulatory pathways for expedited approval as well as new industry and academic collaborations, the
FDA is more involved with accelerating innovation than ever before. What is the agency doing and why is it so
misunderstood? This presentation will offer insights into the agency's actions and philosophy relative to
innovation as well as why it is being negatively perceived by many of its key constituencies."
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6. 4.40PM - 5.20PM 40 Mins
Be FDA Inspection Ready
How to prepare for the inspection, how to prepare your subject
matter experts (SME’s) to respond properly, and how to respond to
an FDA 483 or Warning Letter. Case Studies and Templates are
included. – Featuring Ex FDA’s
• Discussing inspectional protocols – how should you treat
investigators when they are in your facility
• A day in the life of an investigator -- how inspectors prepare and
approach assigned inspections
• New for 2014 – Understanding FDA’s Quality Metrics Initiative –
what’s the latest on the quality initiative and how can you get
prepared for what’s coming?
• New for 2014 – The latest on the FDA’s re-organization of the
inspectional corps and how could it impact your daily operations
and your upcoming inspection
• Best practices in FDA 483 and warning letter management and
recovery
4.00PM - 4.40PM 40 Mins
3.40PM - 4.00PM 20 Mins Networking Coffee Break
5.20PM - 5.30PM 10 Mins Closure: Summary
3.00PM - 3.40PM 40 Mins3.00PM - 3.40PM 40 Mins
4.00PM - 4.40PM 40 Mins
Track A - Sessions Track B - Sessions
Agenda
GLOBALIZATION: THE CHALLENGES AND SOLUTIONS
The Med Device industry is experiencing a significant
transformation. Attest 50% of med Devices used in US are
imported. The Globalization of design, sourcing, manufacturing,
distribution and sales of Med device has Created Challenges and
Opportunities for the entire Med Device industry. The medical
device manufacturing and research and development (R&D) sectors
are extremely complex.
The growth in the Volume of global Partners, Facilities, Suppliers,
and regulations and as well as the increased variety and complexity
of Products access a large number of countries has its employees
on alert. They are Specially Concerned about
• Making and adapting products for different markets
• Greater complexity in supply chains
• Complying with increasingly Complex regulatory Environment
• Raw Material Requirement – Quality Assurance across the Globe
• Protecting your medical device Intellectual Property
The Evolution of Portable Medical Devices
According to Gartner, portable consumer medical devices, such as
blood glucose monitors, blood pressure monitors, insulin pumps
and heart rate monitors, represent the fastest-growing segment in
the medical equipment market. A recent medical semiconductor
report by Databeans also projects that the home medical device
segment will grow by 9 percent (combined annual growth rate or
CAGR) over the next five years. With the advent of various smart
technology and wireless capabilities, this medical field has become
one of the most intriguing with the promise of great potential for
future healthcare.
The Round Table Discussion will emphasize on:
• what risks must be addressed in the management of power
sources for portable medical devices in the critical care
environment.
• User interface: display
• Human machine interface (HMI): keypads, scroll wheels, buttons,
and switches
• Bio-sensor(s)
• Amplification and analog-to-digital conversion of the sensor input
4.40PM - 5.20PM 40 Mins
Debate - Debate - “Yes” or a “No” to Outsourcing
This Will address some of the key benefits, challenges, and trends
in outsourcing medical device design and development and how
they can impact your business
• Govt. Policies on MD Outsourcing
• Coming to Terms with Outsourcing
• what, when, and how much to outsource
• How to select the right partner for your company's needs
GMP Compliance for Quality Control and Contract Laboratories
Quality control and related contract laboratories are considered at
high risk because after testing and approval, drug products and
Active Pharmaceutical Ingredients (APIs) are released to the market
without further check. That's the reason why the FDA and other
agencies put highest emphasis on inspections of QC laboratories.
Even though cGMP regulations have been in place since long time,
the large number of QC related 483's and warning letters
demonstrate that companies have problems with implementation
• FDA Regulations and Requirements Overview
• Calibration and Qualification of Laboratory Equipment
• Sample Testing: Preparation, conduct, documentation
• Handling out of specification (OOS) test results
• Quality assurance of reference standards and other supplies
• Ensuring Integrity of Raw Data and Other records
• Internal audits in preparation for FDA inspection
Significant change in the risk management landscape
After many years of trying to create a consistent worldwide
approach to medical device risk management, success seemed to
be in our grasp with the publication of ISO 14971:2007. Almost
every country harmonized that standard with little or no change.
Unfortunately, the harmonization process in the European Union
created deviations to the standard that must me met as part of the
essential requirements, and ISO 14971 by itself no longer meets
their risk management requirements. This schism with the rest of
the world is causing consternation among medical device
manufacturers that market globally. This talk will provide some
history, some discussion of harmonization, some philosophy, and
some potential solutions to minimizing the impact of the EU
deviations.
3.40PM - 4.00PM 20 Mins Networking Coffee Break
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7. Agenda
Day Two: Friday, March 20, 2014
8.00AM - 8.30AM
8:30AM - 9.10AM
30 Mins Registration/Sponsored Breakfast
40 Mins
Keynote - FDA's New Import Program Concerning International Consequences
• Selecting foreign suppliers
• Reducing the risk of detention
• Negotiating with FDA and U.S. Customs
• Special Provisions
10.00AM - 10.40AM 40 Mins
9.10AM - 10.00AM 50 Mins
Panel Discussion - Advanced Technology - An Essential Resource
• Utilizing new technologies for devices industry
• Analyzing present and prospective
• Demonstrating the benefits of the real time
• An in-depth look at industry from the viewpoints of nanotechnology, Big Data, and Robotic & Artifical
Technologies and vertulization
• Mobile apps: Navigating new Regulatory Guidance on Mobile Medical Apps. FDA stipulations of mHealth
market in the near future. Understanding mHealth parameters.
• MD on cloud: Cloud computing involves the delivery of computing as a service rather than a product.
Cloud computing presents several challenges to FDA’s application of its existing regulatory scheme.
• Big Data: refers to data sets of enormous scope.
• Nano Technology: NanoScience is the study of phenomena and manipulation of materials at atomic,
molecular and macromolecular scale. Nanotechnology is the design, characterisation and application of
structures, devices and systems by controlling shape and size at the nanometer scale.
11.30AM - 12.00PM 30 Mins
10.40AM - 11.00AM 20 Mins Networking Coffee/Tea Break
11.00AM - 11.30AM 30 Mins Sponsors Speaking Opportunity - 2 sponsor
12.00PM - 12.40PM 40 Mins
Keynote - Human Factors & Medical Device
• FDA Perspectives on Human Factors: Conduct a comprehensive risk assessment. Identify and mitigate
risk. Discuss product development plans with FDA before your design is finalized.
• Human Factors & Usability: FDA believes that medical device use error impacts the health and well-beings
of the public and hence its looks closely to HF/Usability. HF/Usability evaluations, test method, and results.
Disapproval can result from inadequate HF/ Usability.
• FDA/CDRH Pre-market Review Perspective: Evaluating use-related risks analyses, and human
factor/usibility information and validation study data including submissions. They would also provide
recommendations to the multi-disciplinary review team on human factors evaluation of manufacturers' design
validation documents as required by the Quality System Regulation. The recommendations are reviewed and
incorporated in FDA letters to the device manufactures.
• Human Factors Preliminary Analyses: Identify and analyse intended users and expected used scenarios
and use environment. Develop Initial product concepts and prototypes. Identify and explore potential device
use-hazards and risk their potential clinical consequences. Explore different design alternatives and identify
the trade-offs between them.
• Formative Evaluation and Design Modification: Formative evaluations are conducted to inform product
development in progress. Guide modification of the device design to optimize the user interface with respect
to device safety and effectiveness.
• Human Factors Validation Testing: Demonstrates and provide evidance that a Medical device can be used
safely and effectively. Identify expected use conditions. Assessments of device-user interactions.
• HF/Usability Report: Discuss user performance after use, particulary perceived reasons for any essential
and critical task errors, failures and difficulties. Feedback on design of the device, labeling and training.
Measuring speed of the task completion if its clinically meaningful.
12.40PM - 2.00PM 80 Mins Networking Lunch
7[Cont...]
The Growing Labeling Concern for Device Manufacturers and Users
Customers and regulatory bodies are requiring device manufacturers to provide more comprehensive
Instructions for Use for all devices, regardless of device class. This session will highlight what problems
customers experience with IFUs, what information customers are looking for from manufacturers, steps
manufacturers need to take to provide comprehensive IFUS, and resources available to help manufacturers
meet this increasingly critical labeling requirement.
• ISO 17664
• AAMI TIR12
• AAMI TIR30
• FDA Draft Guidance on Processing/Reprocessing Medical Devices in Health Care Settings
Future Trends in Medical Device Risk Management."
Risk Analyses have been required to CE Mark medical devices since the 1980's. Risk Management has
been required since 2000, yet there continues to be controversy over Best Practices. This presentation will
summarize where we have been to determine what we should be doing. Future scenarios will be discussed
with recommendations.
Some of the key areas of Discussion will have the below
• Background Highlights
• Current Controversies
• Best Practices
• Future Recommendations
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8. 2.00PM - 3.00PM 60 Mins
Track A - Sessions Track B - Sessions
**Track A is most suitable for Top Level executives from various
depts. However attendees of all levels can attend it.
**Track B is more suitable for Mid-Level Managers from
Compliance, Regulatory, Quality, Project Mgmt & R&D depts.
However attendees of all levels can attend it.
Agenda
4.00PM to 4.20PM 20 Mins Networking Coffee Break
4.20PM to 5.00PM 40 Mins Prize, Sponsor Prize & Certificate Distribution, Summary & Closure
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CMO -Are You choosing them Right?
It's time for medical device and life science instrument OEMs to
take another look at outsourcing the entire manufacturing process
from New Product Introduction through final system test. For years,
other industries have embraced outsourcing as the manufacturing
strategy of choice. While the cost benefits of outsourcing are well
documented, the solutions offered by most outsourcing companies
fall short of what medical device and life science instrument OEMs
require. This Workshop will emphasize on the Key Criteria for
Selecting the Right CMO for you . Below Areas will be Covered.
• CMO Inspection Trends with CMOs
• Assessing CMOs’ Financial Stability
• Assuring Quality from CMOs
Sunshine Act : How ready are we?
• Analyze the New Regulations Released in the Sunshine Act and
How the Requirements Effect Aggregate Spend Reporting
• Reporting 101: Addressing the Issue of Who, What, Where, When
and How to Report Aggregate Spend
• Challenges Occurred in First Period
• Impact on Business due to Additional Exposure
Supply Chain Optimization - Enhancing Controls & Controlling
Risk
Supply chain issues remain major concerns for both FDA and
industry. Supplier problems lie at the root of a significant
percentage of quality risk events and field actions. This session will
provide update on evolving regulatory expectations and concerns,
• Trends and current Agency concerns
• Overview of recent enforcement actions
• Risk considerations
• The six pillars of supplier quality
• Applying critical-to-quality concepts to supplier selection and
management
• Industry best in class practices
• Inspecting quality in vs. root cause investigation and QSR
• Special considerations for early stage suppliers
• Collaborating with vendors on product development
• Outgrowing early suppliers as products or companies mature
• FDA stance on supplier certification
UDI Granular Interpretation & Road Ahead
This session will provide an overview of the high-level interpretation
of the UDI Regulation and will help you gain insight into what has
happened within the FDA leading up to, and after the first major
compliance date for Medical Device Manufacturers. You will be
provided with a glimpse into the forthcoming milestones and
anticipations for the industry in regards to UDI implementation.
• In House System Requirement for UDI Compliance
• Getting started with Global UDI Database
• Understanding the Device Indetifier
• Global Medical Device Nomenclature (GMDN) and GUIDD
• GUDID Submission Options
• The Global Landscape: UDI & Hospital-Related Efforts Around
the World
2.00PM - 3.00PM 60 Mins
3.00PM - 4.00PM 60 Mins3.00PM - 4.00PM 60 Mins
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9. Why San Diego?
March 19-20, 2015
San Diego, CA
CONTACT US
2600 E. Bayshore Road
Palo Alto, CA 94303
Toll Free number: +1-650-284-1695
Email: summit@complianceonline.com
San Diego is a major hub for scientific research and development. The city is an important center for medical
device innovation – leading companies such as NuVasive, Care Fusion, Medipacs and SpectraScience are
headquartered here while companies such as Boston Scientific, Stryker and DePuy are located in nearby San Jose.
The spirit of entrepreneurship not in just San Diego but the whole of Southern California has made it the ideal
environment for start-ups.
As one of California’s legendary coastal cities, visitors come to San Diego to enjoy its wonderful climate, natural
attractions and rich history. Some of the city’s most popular destinations include:
The strong culture of technological innovation, ground-breaking scientific discovery and spectacular urban and
natural heritage makes San Diego the ideal venue for an important industry event like the ComplianceOnline
Medical Device Summit.
The San Diego Zoo is one of the world’s most famous zoological treasures, with a huge botanical plant and
orchid garden as well.
The San Diego Air and Space Museum preserves the rich past of the aviation industry as well as space
technology. It aims to encourage study in science, engineering and technology.
La Jolla Shores is one of the must-see and must-experience destinations for scuba divers, snorkelers and
kayaks. Nature lovers also go to La Jolla to experience the underwater park – around 6,000 acres of tide lands
and artificial reefs with an abundance of marine life.
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