Webinar or Online Training on A comprehensive overview of 510(k) submissionComplianz World
Complianz World is a US based company, and a leading GRC training provider has announced to conduct
Webinar or Online Training on
A comprehensive overview of 510(k) submission
This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
Slides for morning 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 non-CPSC panelist presentations.
This document provides an overview of the FDA 510(k) submission process for medical devices. It begins with background on FDA authority over medical devices and device classification. It then covers key aspects of preparing a 510(k) submission, including what a 510(k) is, where and when to start the process, how FDA reviews submissions, and tips for formatting a 510(k). The document reviews the typical 510(k) review cycle and outcomes, including potential requests for additional information and decisions of substantial equivalence or non-equivalence. It aims to help medical device companies navigate the 510(k) process and timelines.
New requirements for sponsors and laboratories for analyzing clinical trial s...complianceonline123
Learn compliance requirements for clinical laboratories analyzing samples from clinical trials. Understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
This document summarizes a presentation about the World Health Organization (WHO) Certification Scheme for pharmaceutical products moving in international trade. The presentation discusses the introduction and history of the scheme, its objectives to assure drug quality and safety, eligibility requirements for participation, and the types of certificates issued. It also describes how certificates are issued and the advantages of the scheme in standardizing information exchange between countries.
The document provides an overview of the CPSC eFiling Alpha Pilot, which will test electronic filing of product safety data through a small group of volunteers. The pilot aims to streamline import processes, identify high-risk cargo, and generate reports to help the agency with risk assessment and priority setting. Key details covered include what data will be collected on regulated products and specific products on the Substantial Product Hazard list.
Webinar or Online Training on A comprehensive overview of 510(k) submissionComplianz World
Complianz World is a US based company, and a leading GRC training provider has announced to conduct
Webinar or Online Training on
A comprehensive overview of 510(k) submission
This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
Slides for morning 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 non-CPSC panelist presentations.
This document provides an overview of the FDA 510(k) submission process for medical devices. It begins with background on FDA authority over medical devices and device classification. It then covers key aspects of preparing a 510(k) submission, including what a 510(k) is, where and when to start the process, how FDA reviews submissions, and tips for formatting a 510(k). The document reviews the typical 510(k) review cycle and outcomes, including potential requests for additional information and decisions of substantial equivalence or non-equivalence. It aims to help medical device companies navigate the 510(k) process and timelines.
New requirements for sponsors and laboratories for analyzing clinical trial s...complianceonline123
Learn compliance requirements for clinical laboratories analyzing samples from clinical trials. Understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
This document summarizes a presentation about the World Health Organization (WHO) Certification Scheme for pharmaceutical products moving in international trade. The presentation discusses the introduction and history of the scheme, its objectives to assure drug quality and safety, eligibility requirements for participation, and the types of certificates issued. It also describes how certificates are issued and the advantages of the scheme in standardizing information exchange between countries.
The document provides an overview of the CPSC eFiling Alpha Pilot, which will test electronic filing of product safety data through a small group of volunteers. The pilot aims to streamline import processes, identify high-risk cargo, and generate reports to help the agency with risk assessment and priority setting. Key details covered include what data will be collected on regulated products and specific products on the Substantial Product Hazard list.
The document discusses the WHO certification scheme for pharmaceutical products. It provides details on the history and revisions of the WHO certification scheme. It describes the types of certificates that can be issued under the scheme including certificates of pharmaceutical products, statements of licensing status, and batch certificates. It outlines the guidelines for participation in the scheme, requesting and issuing certificates, and procedures for investigating quality defects. The aim of the scheme is to help assure good manufacturing practices and quality of pharmaceutical products being exported between member states.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
The document discusses Certificate of Pharmaceutical Products (COPP), which is a certificate issued by the World Health Organization (WHO) that is required for pharmaceutical companies to export medicines globally. It regulates the import and export of drugs in India. To apply for a COPP, manufacturers must submit documents such as their manufacturing license, product lists, standard operating procedures, equipment lists, staff details and more to the relevant authorities. A COPP is valid for 3 years and helps ensure drugs meet quality standards before leaving the country.
The document summarizes CPSC requirements for adult and children's clothing, including mandatory safety standards and voluntary standards. It discusses four types of safety concerns, strategies to prevent product hazards, and CPSC's role in monitoring voluntary standards and issuing technical regulations if needed to reduce risks. Key requirements outlined are flammability testing, tracking labels, lead and phthalate limits, and restrictions on drawstrings for children's garments. Manufacturers are responsible for ensuring imported products comply with both U.S. regulations and voluntary consensus standards.
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
AQSIQ Faclity Registration Requirement for Foreign Feed, Feed Additives and P...Ken Ziao
AQSIQ Faclity Registration Requirement for Foreign Feed, Feed Additives and Pet Food manufacturers.
They should finish AQSIQ facility registration and MoA register license, from China AQSIQ and Ministry of Agricuture of China, before export to China
For more info, please contact jq@aqsiq.com
Copp- Certificate of Pharmaceutical ProductsDr. Jigar Vyas
The document provides guidelines for applying for a WHO GMP Certificate of Pharmaceutical Product (COPP) from the Indian drug regulatory authority, CDSCO. An application for a COPP must be submitted to the respective CDSCO zonal/sub-zonal office, along with documents like a product permission copy, notarized product summary sheet, and documentation of quality control procedures. CDSCO officers will inspect applicant sites to ensure compliance with WHO GMP guidelines before issuing a COPP, which certifies that a pharmaceutical product is manufactured according to proper standards for international distribution and registration.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
This presentation consist a consolidated list all Regulatory Guidelines for Cleaning Validation. Hyperlink of the applicable guidelines are also given in the presentation.
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
GVK Biosciences (GVK BIO) Clinical Research division has an independent Quality Assurance (QA) unit which conducts audits of services of all business lines within the division on a routine basis to ensure delivery of quality services. The Clinical Research QA staff report
to the Director-QA, GVK BIO who in turn reports to the CEO of GVK BIO
This document discusses regulations for medical devices in various countries and regions. It provides an overview of the regulatory bodies that oversee medical devices in Australia, Europe, the US, Canada, China, Japan, Brazil, and India. For the US, it describes the Food and Drug Administration's role and classifications of medical devices. It also summarizes key concepts around establishing registration and listing of devices, premarket notification (510(k)), de novo classification, premarket approval, and quality system regulations.
The document discusses a workshop on electronic filing of certificates held by the U.S. Consumer Product Safety Commission (CPSC). It provides an overview of the CPSC's current and proposed rules regarding certificates of compliance for imported consumer products. The CPSC aims to modernize certificate collection by requiring electronic filing of certificates with U.S. Customs and Border Protection at the time of entry. This is intended to streamline the entry process and allow the CPSC to more efficiently review products for safety. The document also outlines the CPSC's risk assessment methodology and collaboration with CBP through data sharing and a pilot risk assessment system.
This document discusses medical device administration in China. It outlines the competent authorities that regulate medical devices, including the SFDA and Center for Medical Device Evaluation. It also describes the administration activities like registration, production, sales, and post-marketing surveillance. The document then summarizes the laws and regulations regarding medical devices and classifies medical devices into three categories based on risk. It provides details on administration of production, sales, and registration of medical devices in China.
Regulatory Framework: SOPs For Ethical Regulation Of Drugsbiinoida
The document outlines standard operating procedures and regulatory requirements for clinical trials in India. It discusses maintaining proper documentation for regulatory compliance, including investigator files, informed consent forms, and safety reporting. The order of documents in investigator files is provided. It also summarizes the role and functions of the Central Drugs Standard Control Organisation as the approving authority for drugs, medical devices, and clinical trials in India.
CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
The document discusses the WHO certification scheme for pharmaceutical products. It provides details on the history and revisions of the WHO certification scheme. It describes the types of certificates that can be issued under the scheme including certificates of pharmaceutical products, statements of licensing status, and batch certificates. It outlines the guidelines for participation in the scheme, requesting and issuing certificates, and procedures for investigating quality defects. The aim of the scheme is to help assure good manufacturing practices and quality of pharmaceutical products being exported between member states.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
The document discusses Certificate of Pharmaceutical Products (COPP), which is a certificate issued by the World Health Organization (WHO) that is required for pharmaceutical companies to export medicines globally. It regulates the import and export of drugs in India. To apply for a COPP, manufacturers must submit documents such as their manufacturing license, product lists, standard operating procedures, equipment lists, staff details and more to the relevant authorities. A COPP is valid for 3 years and helps ensure drugs meet quality standards before leaving the country.
The document summarizes CPSC requirements for adult and children's clothing, including mandatory safety standards and voluntary standards. It discusses four types of safety concerns, strategies to prevent product hazards, and CPSC's role in monitoring voluntary standards and issuing technical regulations if needed to reduce risks. Key requirements outlined are flammability testing, tracking labels, lead and phthalate limits, and restrictions on drawstrings for children's garments. Manufacturers are responsible for ensuring imported products comply with both U.S. regulations and voluntary consensus standards.
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
AQSIQ Faclity Registration Requirement for Foreign Feed, Feed Additives and P...Ken Ziao
AQSIQ Faclity Registration Requirement for Foreign Feed, Feed Additives and Pet Food manufacturers.
They should finish AQSIQ facility registration and MoA register license, from China AQSIQ and Ministry of Agricuture of China, before export to China
For more info, please contact jq@aqsiq.com
Copp- Certificate of Pharmaceutical ProductsDr. Jigar Vyas
The document provides guidelines for applying for a WHO GMP Certificate of Pharmaceutical Product (COPP) from the Indian drug regulatory authority, CDSCO. An application for a COPP must be submitted to the respective CDSCO zonal/sub-zonal office, along with documents like a product permission copy, notarized product summary sheet, and documentation of quality control procedures. CDSCO officers will inspect applicant sites to ensure compliance with WHO GMP guidelines before issuing a COPP, which certifies that a pharmaceutical product is manufactured according to proper standards for international distribution and registration.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
This presentation consist a consolidated list all Regulatory Guidelines for Cleaning Validation. Hyperlink of the applicable guidelines are also given in the presentation.
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
GVK Biosciences (GVK BIO) Clinical Research division has an independent Quality Assurance (QA) unit which conducts audits of services of all business lines within the division on a routine basis to ensure delivery of quality services. The Clinical Research QA staff report
to the Director-QA, GVK BIO who in turn reports to the CEO of GVK BIO
This document discusses regulations for medical devices in various countries and regions. It provides an overview of the regulatory bodies that oversee medical devices in Australia, Europe, the US, Canada, China, Japan, Brazil, and India. For the US, it describes the Food and Drug Administration's role and classifications of medical devices. It also summarizes key concepts around establishing registration and listing of devices, premarket notification (510(k)), de novo classification, premarket approval, and quality system regulations.
The document discusses a workshop on electronic filing of certificates held by the U.S. Consumer Product Safety Commission (CPSC). It provides an overview of the CPSC's current and proposed rules regarding certificates of compliance for imported consumer products. The CPSC aims to modernize certificate collection by requiring electronic filing of certificates with U.S. Customs and Border Protection at the time of entry. This is intended to streamline the entry process and allow the CPSC to more efficiently review products for safety. The document also outlines the CPSC's risk assessment methodology and collaboration with CBP through data sharing and a pilot risk assessment system.
This document discusses medical device administration in China. It outlines the competent authorities that regulate medical devices, including the SFDA and Center for Medical Device Evaluation. It also describes the administration activities like registration, production, sales, and post-marketing surveillance. The document then summarizes the laws and regulations regarding medical devices and classifies medical devices into three categories based on risk. It provides details on administration of production, sales, and registration of medical devices in China.
Regulatory Framework: SOPs For Ethical Regulation Of Drugsbiinoida
The document outlines standard operating procedures and regulatory requirements for clinical trials in India. It discusses maintaining proper documentation for regulatory compliance, including investigator files, informed consent forms, and safety reporting. The order of documents in investigator files is provided. It also summarizes the role and functions of the Central Drugs Standard Control Organisation as the approving authority for drugs, medical devices, and clinical trials in India.
CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
Overview of third party testing children's products, including initial certification testing, material change testing, component part testing, and periodic testing. Discussion of recordkeeping requirements and undue influence training requirements.
Overview of testing, certification, and record keeping requirements for consumer products, including children's products. Addresses 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.
The document discusses NABL accreditation, which is provided by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL accredits laboratories to ensure they meet technical standards for competence. The accreditation process involves assessments of a laboratory's management system, technical performance, and participation in proficiency testing. Receiving NABL accreditation improves customer confidence and allows access to domestic and international markets by demonstrating a laboratory's technical competence meets international standards.
Product certification or product qualification is the process of certifying that a certain
product has passed performance tests and quality assurance tests, and meets
qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
Bodies, and they themselves are assessed by international peers against the ISO 17011
standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
protective headgear, the U.S. Federal Communications Commission (FCC)
Telecommunication Certification Body (TCB) program for radio communication devices,
the U.S. Environmental Protection Agency Energy Star program, the International
Commission on the Rules for the Approval of Electrical Equipment Product Safety
Certification Body Scheme (IEECE CB Scheme), MAS (Materials Analytical Services)
Certified Green IEQ program, and the Greenguard Environmental Institute Indoor Air
Quality program. Certification schemes are typically written to include both the
performance test methods that the product must be tested to, as well as the criteria that
the product must meet to become Certified.
2014 updates for durable infant and toddler products. How to locate CPSC data on regulatory non-compliance notices, which are also called "letters of advice" (LOAs). The referenced Excel table will be updated frequently with the names of the firm, the foreign manufacturer, and other information. Businesses may integrate this information into their compliance workflows to assist them in sourcing safe & compliant consumer products.
The document discusses laboratory accreditation. It explains that laboratory accreditation provides formal recognition of competent labs and allows customers to identify reliable testing services. The National Accreditation Board for Testing and Calibration Laboratories (NABL) is India's authorized accreditation body. NABL uses international standards to evaluate labs and accredits them for a maximum of 2 years through a 5 stage process involving an application, assessment, corrective actions, review, and renewal. Accreditation benefits labs through increased business and confidence in their testing data.
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
National Accreditation Board for Testing and Calibration Laboratories (NABL)....Durgadevi Ganesan
National Accreditation Board for Testing and Calibration Laboratories (NABL):
NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers. Accreditation process details are provided in NABL 100B- Accreditation Process & Procedure.
NABL is self-financing and charges fees to Conformity Assessment Bodies to cover operational costs and other expenditure.
NABL offers accreditation services in a non-discriminatory manner. These services are accessible to all testing including medical and calibration laboratories, proficiency testing providers and reference material producers in India and other countries in the region, regardless of the size of the applicant CAB or its membership of any association or group or number of CABs already accredited by NABL. Applicable fees details are provided in NABL 100A- General Information Brochure.
SERVICES PROVIDED BY NABL:
Testing laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’
Calibration laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’
Medical testing laboratories in accordance with ISO 15189 ‘Medical laboratories -Requirements for quality and competence’
Proficiency Testing Providers (PTP) in accordance with ISO/IEC 17043 “Conformity assessment — General requirements for proficiency testing” and
Reference material producers (RMP) in accordance with ISO 17034 “General requirements for the competence of reference material producers”.
BENEFITS OF NABL CERTIFICATION:
Increased trust in Testing/ Calibration Reports issued by the research facility.
Better control of research facility activities and criticism to labs concerning whether they have a sound Quality Assurance System and are actually skilled.
Potential expansion in business because of improved client certainty and fulfillment.
Customers can look and recognize the research centers licensed by NABL for their particular prerequisites from the NABL Web - webpage or Directory of Accredited Laboratories.
Users of certified research facilities appreciate more noteworthy access for their items, in both domestic and international markets.
Savings in terms of time and money due to reduction or elimination of the need for retesting of products.
Increased trust in Testing/ Calibration Reports issued by the research facility.
Better control of research facility activities and criticism to labs concerning whether they have a sound Quality Assurance System and are actually skilled.
Potential expansion in business because of improved client certainty and fulfillment.
NABL ACCREDITATION PROCESS
NABL ( NATIONAL ACCREDITATION BOARD DOR TESTING AND CALIBRATION LABORATORIESGayatriBahatkar1
The document discusses the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL provides accreditation to conformity assessment bodies like laboratories to ensure quality and consistency. Obtaining NABL accreditation benefits laboratories by increasing customer confidence, reducing re-testing, and allowing access to domestic and international markets. The accreditation process involves applying to NABL, assessments of the laboratory's quality system, corrective actions if needed, and ultimately receiving a two-year accreditation certificate if requirements are met.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
This document provides an introduction to Issue 8 of the Global Standard for Food Safety. Key points include:
- Issue 8 focuses on encouraging a strong food safety culture, expanding environmental monitoring requirements, and adding clarity for high-risk production areas and pet food manufacturers.
- The Standard is based on senior management commitment and a HACCP-based food safety system, and specifies requirements for food safety, quality, and legal compliance.
- Certification benefits companies by reducing audits, allowing use of the BRC logo, and helping meet legal requirements and customer demands. The Standard can be audited via announced or unannounced audits.
The document outlines the 10 steps for the CE marking process: 1) Identify applicable directives, 2) Identify conformity assessment procedures, 3) Determine compliance dates, 4) Identify applicable harmonized standards, 5) Ensure compliance with essential directive requirements, 6) Determine if independent assessment is required, 7) Maintain technical documentation, 8) Prepare declaration of conformity, 9) Check for additional national requirements, and 10) Affix CE marking. It also lists the information that should be included in the technical file to demonstrate compliance.
The document discusses the selection and certification process for vendors, including defining vendors and the selection process, the purposes of vendor qualification and certification to comply with regulations and for business purposes, and the various types of vendors categorized by the level of testing they perform themselves versus what the manufacturer requires. It also outlines the key factors considered in vendor selection such as reputation, capacity, location, price, and technical evaluation through testing samples.
This document discusses GMP clearance requirements for medicines manufactured overseas that are supplied to Australia. It outlines the two pathways for obtaining a GMP clearance - desktop assessment and on-site inspection. It provides details on the evidence required for desktop assessments under various international agreements and compliance verification. It also discusses sponsor responsibilities related to overseas manufacturers.
The document summarizes new rules for third party testing of children's products that took effect in 2013. It outlines requirements for initial certification testing, component part testing, material change testing, and periodic testing for continued production. Manufacturers must have products tested by accredited laboratories, issue certificates of compliance, and maintain testing records. The rules aim to provide assurance that children's products meet safety standards for substances like lead and phthalates.
This document provides an overview of the Consumer Product Safety Commission's third party testing program requirements. It discusses the requirements for initial certification testing, component part testing, material change testing, and periodic testing that manufacturers must follow to certify that children's products comply with safety standards. It also outlines the recordkeeping responsibilities and reasonable testing program best practices for non-children's products. The presentation emphasizes exercising due care in relying on third party test results and avoiding any undue influence on testing laboratories.
Similar to Laboratory Application Process (English) (20)
A briefing for the Consumer Product Safety Commission by CPSC staff from the Directorate for Engineering Sciences, Division of Mechanical Combustion Engineering.
The document summarizes a seminar on consumer product safety compliance plans presented by various industry trade groups. It discusses the role of trade associations in educating members on legal requirements, advocating on their behalf with regulators, and facilitating discussions on leading practices. The trade groups emphasize that compliance plans are just one part of safety programs, which also include hazard analysis, risk assessment, and product testing. They recommend establishing clear corporate safety policies, training personnel worldwide, and going beyond minimum safety standards. Recalls are seen as an opportunity to improve safety rather than an indication of failure. Technology can help with tasks like document management, data analysis, and consumer communications.
The document describes Best Buy's product safety compliance program. It outlines the governance structure, which includes oversight from the Board of Directors down to operational teams. It details the product incident management process, including review of incidents and recalls. Best Buy has integrated systems to quickly block the sale and distribution of recalled products. It works with third-party partners and provides guidance on new product categories. Continuous improvement is emphasized through monitoring, training, and review of trends.
Este documento lista los diferentes sectores interesados en la seguridad de los productos de consumo y describe la información y perspectivas que cada uno puede aportar. Los sectores incluyen fabricantes, importadores, comercializadores, instituciones académicas, consumidores, organismos de normalización y certificación, y agencias gubernamentales. Cada sector puede proporcionar datos sobre accidentes, quejas de consumidores, pruebas de productos y cumplimiento de normas. La colaboración entre estos grupos es importante para garantizar la protección de
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.
The document summarizes discussions from a panel on high energy lithium-ion batteries. It covers three main topics:
1. Charles Monahan of Panasonic discussed lithium-ion battery design and manufacturing, including cell components and thermal runaway risks.
2. Don Mays of Samsung presented on the Galaxy Note 7 recall, including an 8-point battery safety test and analyzing reported incidents.
3. Rick Brenner discussed challenges importers face in sourcing safe lithium-ion products, such as unlicensed generics and misleading compliance claims. He suggested stricter standards that mandate battery management system certification.
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.
Este documento resume el panorama del comercio electrónico en México. Algunos puntos clave son: 1) México ocupa el puesto 17 a nivel mundial en atractivo para el desarrollo del comercio electrónico. 2) Actualmente hay 97.2 millones de suscripciones de servicios de Internet en México. 3) 3 de cada 4 usuarios de Internet en México realizaron una compra en línea en 2017. 4) El monto de las operaciones de comercio electrónico en México en 2016 fue de 17.63 billones de dólares
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The document discusses North American cooperation between the US Consumer Product Safety Commission, Health Canada, and Mexico's PROFECO on consumer product safety issues. It provides examples of joint projects between the agencies, including social media campaigns on various safety topics, presentations at industry events, webinars on safety requirements, and customs cooperation initiatives like joint exercises and information sharing. Inter-laboratory cooperation is also summarized, such as exercises comparing testing of lead, phthalates, and X-ray fluorescence technology, as well as staff exchanges and training. A total of 24 simultaneous/joint recalls across North America are mentioned since 2013 involving products like glass tumblers, TV stands, bicycles, speakers, wall adapters, ATVs,
The CPSC works closely with CBP to screen imported consumer products for safety violations. CPSC staff are located at major ports to work directly with CBP during the import process. Using a Risk Assessment Methodology and trade data from CBP, CPSC targets high-risk shipments for examination. CPSC and CBP conduct joint audits of importers to provide guidance on regulations and requirements. Through coordination and data sharing, CPSC aims to intercept violative products and protect consumers.
The document discusses what happens when a shipment is held for examination at a U.S. port of entry. Cargo may be targeted by the Consumer Product Safety Commission (CPSC) or other agencies. The CPSC works with Customs and Border Protection (CBP) at ports. If cargo is held, the responsible agency examines it at a Centralized Examination Site. Examinations can result in full release, sampling and conditional release, or sampling and detention of goods.
The one-day Recall Effectiveness Workshop agenda includes presentations on the recall process, recall data, and communicating hazards. It also has open discussion sessions on what defines an effective recall and how to best utilize social media, in-store notifications, and other forms of communication. Break-out groups will discuss consumer motivation and technological advances to improve recall effectiveness.
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
The document provides information about registering a business account on the CPSC Business Portal. It outlines the multi-step registration process, important concepts like roles and responsibilities, how to make changes to an account, small batch manufacturer certification, and potential problem areas. It also includes examples of the various emails sent during the registration and activation process.
This document summarizes the requirements for manufacturers and importers to certify that their products requiring special packaging comply with the Poison Prevention Packaging Act (PPPA). A General Certificate of Conformity must be filed certifying the special packaging meets the performance specifications outlined in 16 C.F.R. § 1700.15. Manufacturers and importers must maintain records of tests or reasonable testing programs to support their certifications. The document provides guidance on the requirements for PPPA certifications.
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Laboratory Application Process (English)
1. U.S. Consumer Product Safety
Commission (CPSC)
Laboratory Application Process for the CPSC
Third Party Testing
John Golden
Regional Product Safety Attaché (Asia-Pacific)
U.S. Embassy, Beijing
This presentation was not reviewed or approved by the Commission.
It may not reflect its views.
1
2. U.S. Consumer Product
Safety Commission
To be considered for CPSC acceptance as a third party
testing laboratory:
2
3. U.S. Consumer Product
Safety Commission
To be considered for CPSC acceptance as a third party
testing laboratory:
• The laboratory must be ISO 17025 accredited by an
accreditation body that is a signatory to the
International Laboratory Accreditation Cooperation
Mutual Recognition Arrangement (ILAC-MRA).
3
4. U.S. Consumer Product
Safety Commission
To be considered for CPSC acceptance as a third party
testing laboratory:
• The laboratory must be ISO 17025 accredited by an
accreditation body that is a signatory to the
International Laboratory Accreditation Cooperation
Mutual Recognition Arrangement (ILAC-MRA).
• The application must list specifically which rules(s),
standards(s), and/or test method(s) for which the
laboratory is seeking CPSC acceptance.
4
5. U.S. Consumer Product
Safety Commission
To be considered for CPSC acceptance as a third party
testing laboratory:
• Laboratory must be ISO 17025 accredited by an
accreditation body that is a signatory to the
International Laboratory Accreditation Cooperation
Mutual Recognition Arrangement (ILAC-MRA).
• The application must list specifically which rules(s),
standards(s), and/or test method(s) for which the
laboratory is seeking CPSC acceptance.
• Laboratories must apply through the CPSC website.
5
7. U.S. Consumer Product
Safety Commission
There are additional requirements specified
under the law if:
• The laboratory has ownership or
controlling interests by a manufacturer or
importer
7
8. U.S. Consumer Product
Safety Commission
There are additional requirements specified
under the law if:
• The laboratory has ownership or
controlling interests by a manufacturer or
importer
• The laboratory has ownership or
controlling interests by a government
8
9. U.S. Consumer Product
Safety Commission
Laboratories that apply must
agree to comply with the CPSC
requirements published in the
Code of Federal Regulations at
16 CFR part 1112.
http://www.gpo.gov/fdsys/pkg/FR-2013-03-12/pdf/201304649.pdf
9
10. Web Resources
• Main Information Page for Lab Acceptance
http://www.cpsc.gov/en/Business--Manufacturering/Testing
Certification/Lab-Accreditation/
• Link to Submit Application:
http://www.cpsc.gov/cgibin/labregentry/
• Searchable List of CPSC-Accepted Laboratories
http://www.cpsc.gov/cgi-bin/labsearch/
• CPSC Chemical Test Methods
http://www.cpsc.gov/Business--Manufacturing/TestingCertification/Lab-Accreditation/Test-Methods/
• List of CPSC rules / standards requiring third party testing
http://www.cpsc.gov/Business--Manufacturing/Testing-Certification/
Lab-Accreditation/Rules-Requiring-Third-Party-Testing/
10
11. U.S. Consumer Product
Safety Commission
Thank You!
John Golden
Regional Product Safety Attaché (Asia-Pacific)
U.S. Embassy, Beijing
Phone: 86-10-8531-3318
Fax: 86-10-8531-3652 (fax)
JGolden@cpsc.gov
GoldenJx@state.gov
11