The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/QYSo/
Views: 3193 GlobalCompliance Panel
Free overview training video on GMP for Medical devices. The training covers the current Good Manufacturing Practices FDA regulation (FDA 21 CFR 820). It is also called Quality System Requirements for medical devices. You can acces the full course at: http://www.caliso9000.com/medical_device_GMP.html Also see our Pharmaceuticals GMP video at: http://www.youtube.com/watch?v=55rPbZo3Xpk Join our Blog at: http://www.iso-9001-caliso.blogspot.fr or our Facebook page: https://www.facebook.com/calisocorporation
Views: 43495 CALISO9000
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. More Info Click Here - https://www.globalcompliancepanel.com Help us caption & translate this video! http://amara.org/v/IZGW/
Views: 2900 GlobalCompliance Panel
Watch and Learn : 21 CFR Part 11 Regulations This article is meant to provide a very high level overview of the key elements of 21 CFR Part 11 regulations from the Food and Drug Administration. It delves into the following topics: 1. Introduction to 21 CFR Part 11 regulations 2. Key elements of 21 CFR Part 11 • Electronic Records : Definition of Electronic Records • Electronic Signatures: Definition of Electronic Signatures • Audit Trails: Definition of Audit Trails, ALCOA definition, basics of what goes into an audit trail. 3. Deeper dive into Subpart B: Electronic Records • Subpart B: 11.10 and 11.20 – Controls for Closed and Open systems • Subpart 11.50: Signature Manifestations • Subpart 11.70: Electronic Record Linking 4. Deeper dive into Subpart C: Electronic Signatures • Maintenance of uniqueness • Periodic revisions of passwords • Prevention of unauthorized actions 5. Advantages for Illumina LCM Consumables Manufacturing • Trending • Speeding up the approval process for records • Cost savings • Efficiency in maintenance, retrieval and submission of records. 6. Proposed action plan for LCM Consumables Manufacturing For more information on 21 CFR part 11 regulations, please visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 For more information on Quality System (QS) Regulation/Medical Device Good Manufacturing Practices, visit https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ For More information on Illumina products, visit https://www.illumina.com/ For more information on 21 CFR Part 820: Quality System Regulations, visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
Views: 11029 Illumina LCM Validation HQ
Overview of Medical Device Quality Management System. We do not claim any ownership over the curated content. All content, trademarks, service marks and logos are owned by the content producers or licensed to YouTube, and are subject to copyright and other intellectual property rights under the law.
(Part 1 of 3) General overview of medical device regulation.
Overview of the FDA Good Manufacturing Practices (GMP or cGMP) for Finished Pharmaceuticals. You can take the full course at: http://www.caliso9000.com/pharmaceutical_gmp.html Join our Blog at: http://www.iso-9001-caliso.blogspot.fr or our Facebook page: https://www.facebook.com/calisocorporation
Views: 49274 CALISO9000
This is the first five minutes from this section of the training program "Quality Systems Training - How to prepare for an FDA quality system inspection." http://www.360performancecircle.com/products/category/fda-compliance This training was created by the FDA for the Dental Trade Alliance (DTA).
Views: 563 Kaizen Institute Online
In this course, we will discuss the regulations and practices for the production of medical devices as specified in the FDA’s quality system regulation (or QSR).
Views: 283 UL PURE Learning
Learn how pharmaceutical and medical device manufacturers can comply with the FDAs 21 CFR Part 11 regulations. NiceLabel will explain what is needed to comply with regulations pertaining to electronic records, electronic signatures, and audit trails. NiceLabel's Control Center Enterprise is the perfect software for FDA regulated companies that need label lifecycle management. Global organizations can consolidate their printing from each region and centralize on a single NiceLabel platform.
Views: 23285 NiceLabel
The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" – "fast cycle" product development. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/LJLB/
Views: 8170 GlobalCompliance Panel
21 CFR 211.22 - Responsibilities of the Quality Control Unit - Subpart B
Views: 49 Sam Pandit
To get 21 CFR Part 820 Quality Management System (FDA QSR) For Your Medical Device. QSR Compliance for Medical Device Manufacturers. https://www.operonstrategist.com/21-cfr-part-820-quality-system-regulation/
Views: 54 Operon Strategist
Course Overview: Identification and Traceability – Subpart F Course introduction Identification – Sec 820.60 Part numbers and product numbers General rules Traceability – Sec 820.65 Lot and serial numbers Typical mistakes Unique device identification (UDI) UDI requirement Visit: www.learnaboutgmp.com
Views: 229 Learnaboutgmp Online Training
Views: 236 Learnaboutgmp Online Training
Noris Medical is directed by experienced physicians and professional engineers focusing on developing, designing and building innovative products for the medical field. Within this framework, Noris Medical is focused on original products and systems for dental applications. The synergetic activity of the Noris Medical team results in advanced products and outstanding systems that help dentists and patients alike. Each new product and system developed is supplied with comprehensive peripheral tooling needed for its successful implementation. Noris Medical offers responsive customer support and ongoing professional training courses to the global community of dental surgeons and technicians. With decades of collective professional experience, Noris Medical strives to provide the highest quality products and systems based on sound engineering principles and excellent manufacturing practices. Noris Medical improves the lives of dentists and patients around the world with the leading technology in dental implant systems. Engineering at NORIS Noris Medical engineering team consist of dentists, dental technicians, mechanical engineers and production experts, all examining the needs of the dental practice in order to design and develop innovative products to support and enhance dentistry. Noris Medical takes great care in selecting materials, production methods, sterilization and packaging of its dental implants, associated instruments, components and kits. Noris Medical is using state-of-the-art machinery and CAD/CAM technologies in order to design and optimize the manufacturing processes of advanced prosthetic solutions made of commonly used materials in the dental field such as titanium and zirconia. Noris Medical dental products are designed for the highest performance and are engineered for a lifetime of health. Quality at NORIS Noris Medical invests significant resources in creating an environment for the design and manufacture of its dental products. Keeping patient safety at the forefront throughout the process, Noris Medical complies with international standards for manufacturing and quality. The entire manufacturing process is monitored and recorded for total process traceability. All facilities are subjected to strict inspection procedures. • Products carry the CE mark and meet the European Medical Device Directive (93/42/EEC). • Products received the FDA Clearance Premarket Notification (510k) (K140440, K153043, K151909). • Meticulous quality control system is in compliance with EN ISO 13485:2016 and FDA QSR 21 CFR Part 820. • Facilities are subject to routine audits by international auditors. • Class 10,000 Clean Room for production. Range of Implants manufactured by Noris Medical: Dental Surgeon’s requirements and patient’s wellbeing are in the focus of our engineering group when developing our non-compromising Implant Systems, the large assortment of which gives an answer to nearly every clinical condition. • Tuff • Tuff Pro • Tuff TT • Onyx • Cortical • PteryCore • PteryFit • Zygomatic • MBI & MBI NC • Mono #NorisMedical FOLLOW US ON: Twitter : https://twitter.com/ChannelDentist Facebook: https://www.facebook.com/Dentistchannelonline Linkedin : https://www.linkedin.com/company/dentistchannelonline/ Get your FREE daily dental news, Dental articles, live dentist videos on the current topics online Website : https://dentistchannel.online YouTube Subscription : https://www.youtube.com/c/DentistChannelOnline?sub_confirmation=1
Views: 134 DentistChannel.Online
AAMI has updated its industry training course, "The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements." The updated course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. For more information, visit www.aami.org/industrytraining
Views: 275 aamiconnect
Course Description: This course introduces the updated 2016 version of the ISO 13485: “Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes,” the international reference standard for quality systems for medical device manufacturers in regulatory systems across the globe. This course covers the following topics: • Basic principles of ISO 13485:2016 • A step-by-step guide of ISO 13485:2016 requirements • Detailed explanations of each requirement and quality system links between the requirements
Views: 4051 WMDO
Learn about FDA 21 CFR Part 11 in layman's terms. -- If you’re involved with the life sciences industry, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but unless you work in a compliance group, you might not understand what it’s about or why it’s important. In our webinar, Sally Miranker, head of computer system validation in Perficient’s life sciences practice, “decoded” the secrets of 21 CFR Part 11. Building on our popular blog post series, Sally explained the regulations in layman’s terms and offered implementation insights and case study examples. To view this webinar in its entirety, please visit: http://www.perficient.com/Thought-Leadership/On-Demand-Webinars/2015/Decoding-21-CFR-Part-11 Stay on top of Life Sciences technologies by following us here: Blog: http://blogs.perficient.com/lifesciences Twitter: http://www.twitter.com/Perficient_LS Facebook: http://www.facebook.com/Perficient LinkedIn: http://www.linkedin.com/company/165444 Google+: https://plus.google.com/+Perficient SlideShare: http://www.slideshare.net/PerficientInc
Views: 13063 Perficient, Inc.
FDA is increasing emphasis on scrutiny of computer systems validation and adherence of 21 CFR part 11 compliance validation to companies under FDA regulatory jurisdiction. A third of FDA’s recent warning letters have been with respect to improper or ineffective QA validation practices. Increasing use of automated manufacturing and quality system is forcing exposure of computer systems. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, meeting the regulatory requirements is a daunting task and 21 CFR Part 11 compliance is a major focus for audits. This seminar will discuss the basics of 21 CFR Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about QA validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies will be used to highlight common issues and potential solutions. We will ensure your readiness for 21 CFR Part 11 compliance to confidently face the next FDA compliance audit.
Views: 6723 Indium Software
Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This Video will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/KApN/
Views: 1789 GlobalCompliance Panel
Wednesday, November 14 @ 1pm EST, we are hosting a live webinar explaining the new quality system software developed by RouteMyData. RouteMyData™ collaborated with Mary Vater and the rest of the Medical Device Academy team to offer a flexible, cloud-based software solution to streamline core quality management system processes. This quality system software takes advantage of the Google G Suite™ in order create an low-cost solution for small and mid-size companies. The system can be populated with your own quality system procedures, or Medical Device Academy has a complete turn-key quality system ready for implementation. The quality system software applications comply with ISO 13485:2016 and the FDA quality system regulations (i.e., 21 CFR 820). The system is also Part 11 compliant.
Views: 331 Medical Device Academy
Name: Validating SharePoint 2013 for 21 CFR Part 11 Environments Date & Time: Friday, 9th August -11:00am EDT (New York), 4:00pm GMT (London), 5:00pm CET (Barcelona) Presenter: Paul Fenton, President & CEO, Montrium Summary: When used as a system for managing regulated content and processes, SharePoint is subject to the requirements of 21 CFR Part 11 and related requirements. During this session we will review the approaches being taken by companies to validate their SharePoint environments, and emerge with a set of guidelines for a risk-based validation strategy for SharePoint. We will explore the differences in approach for cloud based environments versus on premise deployments. You will gain a clear understanding of why, when and how to validate SharePoint, and there will be a strong focus on reducing the time, cost and resources required to validate a SharePoint environment whilst providing maximum quality, control and ROI. Topics will include: - Managing and validating a mixed SharePoint environment that includes both controlled and non-controlled SharePoint sites - Risk evaluation methods for SharePoint systems - A Step by Step overview of the risk-based validation process following the GAMP5 model - Implementing effective configuration and change control procedures for SharePoint-based systems - SharePoint Online versus SharePoint on-premise Find more at www.montrium.com
Views: 17145 Montrium
The Premarket Approval (PMA) pathway is complex. The PMA application needs to provide a reasonable assurance that the device is safe and effective for its intended use (21 USC 360e(d)(1)(A)). To do this, companies must submit valid scientific evidence (21 CFR 860.7(c)), typically derived from a clinical study. The application also needs to include documents demonstrating compliance with the Quality Systems Regulations (QSRs) (21 CFR Part 820). The PMA must also include draft labeling, information regarding product composition, preclinical data, and a summary of relevant literature (21 CFR 814.20(b)). For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/Notq/
Views: 1106 GlobalCompliance Panel
(Part 2 of 3) Regulation of medical device software.
If you read the FDA quality system regulation clause 820. 25 (personnel) it states that: "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibi Training shall be documented". The term "all personnel" is a very important part of this clause. Very often we provide GMP training to those individuals who work within the disciplines of engineering, regulatory and quality. Furthermore we usually depend on the quality assurance personnel or those regulatory personnel within our organization to be the key providers of information during an FDA QSIT investigation. There may be times when the FDA will want to speak with all disciplines within an organization from the CEO on down. All personnel means "all personnel", which means that anyone involved in the design, manufacture, inspection, test, packaging, and/or service of the device should have adequate training to the GMP requirements. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/LJbV/
Views: 10568 GlobalCompliance Panel
At IVT's 12th Annual Change Control, Joseph Zec outlined the US Food and Drug Administration's expectations for a company's corrective and preventive action (CAPA), as outlined in Code of Federal Regulations Title 21 Part 820. In this presentation, Zec analyzed the regulatory requirements for CAPA in terms of identification and investigation, verification, dissemination of information, and submission for approval.
Views: 2759 IVT Network
click here for book!: http://www.medicaldevicebooks.com/Book%20%20%20FDAs%20QSR.htm A complete compendium to FDA's Quality System Regulation (QSR) with relative references to FDA's Quality System Inspection Technique (QSIT). This book takes into account the latest up-to-date trends in Agency views. Order for only $ 99.00
Views: 1839 medicaldeviceschool
An FDA Investigator's Viewpoint: How To Assure Your Seven Subsystems are in Compliance and Linked Together In 15 years, FDA medical device specialist Lori Lawless has seen every violation of the medical device QSR that you can think of. This top-rated speaker will create a lively and informative discussion about the Quality Systems Inspection Technique (QSIT) approach to inspections. Lawless will describe how she asks for information, analyzes that information and writes EIR and Form 483 reports using the QSIT and QSR framework. Attendees will learn: • What elements of QSIT the FDA focuses on and why • Common mistakes firms commit and how they can be avoided • What are red flags that investigators notice that typically go unnoticed by quality assurance and compliance managers • How QSIT violations appear in EIRs, 483s and warning letters Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
Views: 1191 FDAnews Video Library
A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval (PMA). There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807, as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this session will address key resources when making critical decisions.
Views: 2330 CambridgeHealthtech
Online Compliance Panel mainly focusing on providing standard quality training to compliance professionals on risk management, quality management, corporate governance and regulatory compliances.
Views: 276 OnlineCompliance Panel
Are you a medical device company with one of the following challenges? - Are you setting up your quality system for the first time? - Are you preparing for an Audit? - Are you executing remediation’s as a result of an FDA four eighty three (483) or warning letter? - Or do you need contracted resources to assist with specific areas of the quality system? Without competent assistance in a timely fashion, these challenges could: - Prevent your product from getting unto the market - Produce adulterated products leading to legal ramifications - Cause recalls of your product negatively impacting your bottom line - Or Cause consent decrees that put you out of business ADB Consulting is here to help. We provide assistance in achieving or maintaining compliance to FDA and International regulations? We assist in complying to regulations such as - twenty-one CFR Part eight twenty (21 CFR part 820) - twenty-one CFR Part eleven (21 CFR Part 11), - IEC sixty two three o four (IEC62304) - ISO thirteen four eighty five (ISO13485) - ISO fourteen nine seventy one (ISO14971) - IEC Six o Six o one (IEC60601) - and more We are able to assist in any and all areas of quality. Including but not limited to: - Design Controls - Risk Management - Process, Systems, Equipment and Software Validation - Complaint Management - Non Nonconformance Management - Corrective Action and Preventive Action Management - Plus Others Our process is as simple as 1 2 3. 1. We Assess the gaps - an analysis ranging from a few hours to a few days. 2. We Execute the work - an interactive process with your staff. 3. We Report - a final account of successful completion at the conclusion of the process. Contact us at 1-877-ADBCCRO or drop us a line at [email protected]
Views: 16 Andre Butler
FDA regulates the nonclinical safety testing of Drugs, Biologics and Medical Devices under a regulation called The Good Laboratory Practices (GLP)regulation. This webinar will address the reasoning for and the requirements of the GLP regulation. For More Info: https://www.globalcompliancepanel.com Help us caption & translate this video! http://amara.org/v/IZGa/
Views: 785 GlobalCompliance Panel
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected]
Views: 2273 GlobalCompliance Panel
http://sterlingmedicaldevices.com How much trouble and effort will it take to get FDA and CE Approval for my medical device? Regulators want to see a very specific design process, strong quality control, robust risk management and an airtight submission package. At Sterling Medical Devices, the FDA has accepted our thorough Design History Files (DHF) every time, showing that we have tried to think of every possible scenario through software verification and medical device testing. We ensure that the medical device software and medical device hardware are doing what they are supposed to be doing and designed to do. Learn more from Bruce Swope, VP of Engineering, who has over 25 years' management experience in medical device development, and John Campbell, Director of Quality, who has over 20 years in medical device development, device testing and verification. Contact Bruce to learn more. Visit: http://sterlingmedicaldevices.com/contact-us Email: [email protected] Call 201-227-7569 x2.
Views: 9882 Sterling Medical Devices
(Part 3 of 3) Innovator Implications - FDA Regulation of Medical Device Software
Want to learn more about InstantGMP™ software? Get in touch: https://www.instantgmp.com/ InstantGMP™ is a comprehensive batch manufacturing and quality system software that manages and organizes manufacturing processes through built-in structured, connected, interactive, paperless, FDA compliant workflows that maximize production uptime. Our unique system satisfies the requirements for 21 CFR Part 11, 111, 211, and 820. Our software lays the foundation for improving product quality and consistency, scaling up operations, complete end-to-end traceability, reduced recall risk, and compliance with regulations. It is especially useful for companies just getting started or considering transitioning from paper-based records to electronic. Additionally, InstantGMP™ benefits several company types, such as Contract Manufacturers, Packagers, Wholesalers, and Distributors. It is also ideal for investors and investment firms looking to protect their investments.
Views: 5 InstantGMP , Inc.
This is a recording of Seapine's webinar on FDA Design Traceability Requirements for Device Development with John Avellanet, Managing Director & Principal at Cerulean Associates, LLC, and Larry Nicholson, Business Development Manager for Life Sciences at Seapine Software. Additionally, you download the FDA Expectations for Traceability in Device Design slide deck and view the Q&A on our blog: http://bit.ly/oAQsnD
Views: 4126 seapineview