What data can you use to drive your business and improve product design? CPSC has databases you can use to look for product problems by searching through consumer product-related incidents, injuries and deaths to take proactive action and minimize risk. CPSC experts will discuss how these databases are used by CPSC internally to examine potential actions; how to search and use CPSC’s national injury database (NEISS) and SaferProducts.gov to identify problems; and how these databases may benefit business and industry in promoting safer products.
Slides for afternoon discussion session of electronic certificate workshop on a *proposed* amendment to the current certification rule, 16 CFR Part 1110. Slides consist of CPSC staff presentation followed by other federal government participants and non-federal government panelist presentations.
What data can you use to drive your business and improve product design? CPSC has databases you can use to look for product problems by searching through consumer product-related incidents, injuries and deaths to take proactive action and minimize risk. CPSC experts will discuss how these databases are used by CPSC internally to examine potential actions; how to search and use CPSC’s national injury database (NEISS) and SaferProducts.gov to identify problems; and how these databases may benefit business and industry in promoting safer products.
Slides for afternoon discussion session of electronic certificate workshop on a *proposed* amendment to the current certification rule, 16 CFR Part 1110. Slides consist of CPSC staff presentation followed by other federal government participants and non-federal government panelist presentations.
Overview of third party testing rules for children's products, including initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed. Pairs with video at http://www.youtube.com/watch?v=cR4RXQjmqC8
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
Are you ready to implement FDA Food Safety Modernization Act?Nikoo Arasteh
Food Modernization Act was signed into law on January 5th 2011. Related regulations are being written and will be enforced piece by piece. Companies will have between 2 to 4 years to complete implementation of required safety systems based on their operation size. This presentation shows what FSMA is about, who will be impacted and what the deadlines are for compliance.
Recent FSMA Updates and what the FDA Expects of YouTraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Can you handle the recent FSMA curveballs?
The FDA made a big splash when it issued a set of “re-proposed” food safety regulations under the Food Safety Modernization Act (FSMA), including regulations for Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-Based Preventative Controls (HARPC) for Human Food.
Two of the significant issues that the FDA is addressing are how product testing and supplier verification fit into FSMA’s requirement for food companies to verify that their preventative controls effectively and significantly minimize hazards at their facilities.
This webinar will provide an overview of FDA’s comments on these two topics and insight about the legal issues they may raise for food companies.
Further, the webinar will explore how the FDA expects you to implement FSMA, and what the FDA expects for firms to show they are in compliance.
U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)Registrar Corp
The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) presents many important changes for companies exporting food to the United States.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both before and after the relaxed pandemic regulations, the FDA began to examine its current market authorization process for medical devices...
Overview of third party testing rules for children's products, including initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed. Pairs with video at http://www.youtube.com/watch?v=cR4RXQjmqC8
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
Are you ready to implement FDA Food Safety Modernization Act?Nikoo Arasteh
Food Modernization Act was signed into law on January 5th 2011. Related regulations are being written and will be enforced piece by piece. Companies will have between 2 to 4 years to complete implementation of required safety systems based on their operation size. This presentation shows what FSMA is about, who will be impacted and what the deadlines are for compliance.
Recent FSMA Updates and what the FDA Expects of YouTraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Can you handle the recent FSMA curveballs?
The FDA made a big splash when it issued a set of “re-proposed” food safety regulations under the Food Safety Modernization Act (FSMA), including regulations for Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-Based Preventative Controls (HARPC) for Human Food.
Two of the significant issues that the FDA is addressing are how product testing and supplier verification fit into FSMA’s requirement for food companies to verify that their preventative controls effectively and significantly minimize hazards at their facilities.
This webinar will provide an overview of FDA’s comments on these two topics and insight about the legal issues they may raise for food companies.
Further, the webinar will explore how the FDA expects you to implement FSMA, and what the FDA expects for firms to show they are in compliance.
U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)Registrar Corp
The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) presents many important changes for companies exporting food to the United States.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both before and after the relaxed pandemic regulations, the FDA began to examine its current market authorization process for medical devices...
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...
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
FDA Extends the Timeline to Respond to Additional Information RequestsEMMAIntl
The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers’ which was originally released in June, to give device sponsors additional time in responding to FDA’s requests for additional information for device applications that are on hold.
At the onset of the pandemic, FDA realized that device makers were faced with unprecedented challenges related to supply chain issues, human resources, etc., while on the other hand, the FDA saw a surge in EUA activities which required shifting of staff resources at the FDA. During this time, the FDA released a guidance document to extend the timeline for responding to the FDA’s requests for submissions/applications that were put on hold. The originally released guidance document provided a sigh of relief to device sponsors by allowing an additional 90 day period beyond the response date initially assigned...
ClearedJobs.Net is a proud sponsor of the Bethesda YAFCEA Federal 2.0 Webinar series. Today's presentation was by Sanjay Koyani, Director of Web Communications for the FDA.gov. Sanjay shared with the webinar participants his best practices for bringing critical information to diverse audiences.
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or device-led combination product) that will “provide for more effective treatment or diagnosis of life-threatening or irreversibility debilitating diseases or conditions”...
Overview of CPSC, Health Canada, and Profeco cooperation, legislation, joint recalls, and including a case study of stroller regulatory requirements in all 3 jurisdictions.
Welcome to the January Edition of Crisis Management’s RecallRegister, Aon’s monthly recall and product safety newsletter. This publication provides a review of the month’s recalls asreported by the U.S. Consumer Product Safety Commission (CPSC), the U.S Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA), National Highway Traffic Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA). In addition to recall announcements, RecallRegister provides an update on the product recall and contamination insurance marketplace and environment. Each month, we highlight issues of importance including new markets and capacity, significant recall events and changes in legislation affecting the consumer products industry.
As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.
Similar to SaferProducts.gov: CPSC's Public Database (20)
A briefing for the Consumer Product Safety Commission by CPSC staff from the Directorate for Engineering Sciences, Division of Mechanical Combustion Engineering.
Regulatory cooperation should be relevant and responsive to real world challenges. This panel provides perspectives on new trends, products, and hazards and what can be done within the North America Cooperation framework. Points of focus: Cooperation and best practices, Policy Alignment, Consumer messaging.
Presenters: Agustin Adame, Consultant; Belinda May, ICPHSO President and Partner, Dentons US LLP; Carol Pollack-nelson, Ph.D. Independent Safety Consulting; Gene Rider, Eponent, Principal.
Hazards associated with high energy density batteries are common to all three jurisdictions. How can risk to consumers be reduced and what steps have already been taken by stakeholders in North America? Points of focus: 1. Industry's product safety processes pre- and post-market. 2. Understanding and eliminating failure modes. Challenges and how can stakeholders and regulators work together to improve safety?
Presenters: Charlie Monahan, Director, Regulatory Compliance, Panasonic; Don Mays, Chief Safety and Quality Officer, Samsung; Rick Brenner, President, Product Safety Advisors, LLC.
Stakeholders and regulators discuss the benefits and challenges posed by the rapid expansion of e-commerce. Discussion of industry processes and best practices. How can regulators help platforms help their sellers and consumers?
Presenters: Doug Hyland, Compliance Program Manager, zulily; Stuart Schmidt, Manager, Trade Compliance, UPS; Carlos Ponce Beltran, Deputy Attorney for Telecommunications, PROFECO.
Presentation by Blake G. Rose, Director, Defect Investigations Division Office of Compliance and Field Operations on CPSC Review of Recall Process and Standard Notifications.
Presentation Date: July 25, 2017
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Thesis Statement for students diagnonsed withADHD.ppt
SaferProducts.gov: CPSC's Public Database
1. CPSC’s Public Database
Dean Woodard
*This presentation was prepared by CPSC staff. It has not been reviewed or approved by, and
may not necessarily reflect the views of, the Commission.
2. CPSC Need for Death/Injury/Incident Data
Set Priorities
Support Ban or Recall of Hazardous Products
Convince Industry and Others of Need for
Product Standard
Support Development of Product Standards
Evaluate the Effectiveness of Product Standards
Develop Information and Education Campaigns
to Raise Public Awareness of Product Safety
3. Consumer Product Safety
Improvement Act of 2008
Signed into law in August 2008
http://www.cpsc.gov/cpsia.pdf
Sec. 212. Establishment of a Public Consumer
Product Safety Information Database
4. Sec. 212. Establishment of a Public Consumer
Product Safety Information Database.
Establishment of a publicly available, searchable, internet
based website.
Searchable by manufacturer or private labeler.
Transmission of reports to manufacturers or private
labelers within 5 business days of receiving report.
Reports of harm relating to the use of consumer products
and other products or substances regulated by CPSC that
are received by CPSC are to be made available in a
database no later than 10 days after manufacturer or
private labeler is sent report.
5. H.R. 2715
Delays publication of report up to 5 additional days if a
manufacturer submits a Materially Inaccurate claim.
Additional effort to collect model, serial number, or
photo of product.
16. Eligible for release on Saferproducts.gov
Consumer product identified
Report of (potential) harm
Manufacturer identified
Contact information of submitter
Verification of content by submitter
Consent of submitter to publish
Category of submitter
Date of incident
17. Contact Information
Dwoodard@cpsc.gov
U.S. Consumer Product Safety Commission
4330 East West Hwy
Bethesda, MD 20814