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Timestamp: 2013-05-19 12:15:41
Document Index: 598602212

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The 510(k) Submission Requirements, Contents
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on The 510(k) Submission: Requirements, Contents, and Options Date: Thursday, June 20,... Documento Adobe PDF
The 510(k) Submission Requirements,...
GlobalCompliancePanel Your Gateway to Regulatory Compliance
Date: Thursday, June 20, 2013 Time: 10:00 AM PDT | 01:00 PM EDT
This presentation will provide an understanding of...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on The 510(k) Submission: Requirements, Contents, and Options Date: Thursday, June 20, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Register Now Location: Online Instructor: Jeff Kasoff Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. Areas covered in the session: l When to submit a 510(k) for a new or modified product l Types of 510(k) submissions and when to use each l What is the submission process l What is contained in a 510(k) submission package l How to know whether clinical data is required l How is the submission package assembled l User fees and 510(k) submissions l How to interact wit
Effective Hazard Analysis to Meet FDA and ISO 13485 2003
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management... Documento Adobe PDF
Effective Hazard Analysis to Meet FDA...
Effective Hazard Analysis to Meet FDA and ISO 13485: 2003
Date: Tuesday, June 18, 2013 Time: 10:00 AM PDT | 01:00 PM EDT
Register NowLocation: Online
Instructor: Markus Weber
FDA-GMPs, known as Quality...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management Requirements Date: Tuesday, June 18, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Register NowLocation: Online Instructor: Markus Weber Overview: FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle. The starting point for each risk management lifecycle is the Hazard and Risk Analysis which provides safety critical design input for the device design. Areas covered in the session: l Structure of a Risk and Hazard Analysis document l Stakeholders and participants l How to conduct a hazard analysis meeting l Meeting ground rules l Hazard and Harm characteristics l Methods to identify potential hazards l Risk and Risk Rating methods l Risk mitigation strategies l Risk assessment and Residual Risk Who Will Benefit: l Project Leaders l Design
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on FDA-Compliant Medical Device Design Control Date: Thursday, June 27, 2013 Time: 10:00... Documento Adobe PDF
FDA-Compliant Medical Device Design...
Date: Thursday, June 27, 2013 Time: 10:00 AM PDT | 01:00 PM EDT
Understanding, interpreting, and implementing design control...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on FDA-Compliant Medical Device Design Control Date: Thursday, June 27, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Register NowLocation: Online Instructor: David Lim Overview: Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment. Areas covered in the session: l Federal Statutes and Regulations Governing Medical Devices in the US l Introduction and Definitions l Design and Development Planning l Design Input l Design Output l Design Review l Design Verification And Validation including Software Validation l Design Transfer l Design Changes l Design History File (DHF) l Device History Record (DHR) and Device Master Record (DMR) Who Will Benefit: l R&D Scientists, Eng
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on FDA s 21 CFR 11 Add-On Inspections - Recent Updates Date: Thursday, June 20, 2013... Documento Adobe PDF
FDA's 21 CFR 11 Add-On Inspections -...
FDA s 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on FDA s 21 CFR 11 Add-On Inspections - Recent Updates Date: Thursday, June 20, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 2 Hours Register NowLocation: Online Instructor: Angela Bazigos Overview: In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. Areas covered in the session: l What is FDA s most current thinking related to computers and electronic records? l What are the inspection trends? l What are most frequent recent citations for Part11? l What are the most frequent deviations for computer system
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Practical Water System Design and Operation Issues Impacting Biofilm Control Date:... Documento Adobe PDF
Practical Water System Design and...
Impacting Biofilm Control
Instructor: Teri C.
Most people who design, maintain,...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Practical Water System Design and Operation Issues Impacting Biofilm Control Date: Thursday, June 27, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Register NowLocation: Online Instructor: Teri C. Soli Overview: Most people who design, maintain, and monitor high purity water systems have heard of biofilm and a few "rules" about how to control and monitor it. Unfortunately, many of these "rules" such as flow rates, dead legs, surface smoothness and the like are either only half right or frankly wrong. Once there is an understanding of the basics of how biofilm really develops on surfaces and how that protects it, it is easier to see how it can impact the operability of various unit operations in a water system and why it is so hard to control and even to monitor accurately. Areas covered in the session: l Understand biofilm basics and how it develops l Understand the impact of biofilm on the co
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Preparing for and Surviving an FDA Inspection Date: Wednesday, June 26, 2013 Time:... Documento Adobe PDF
Preparing for and Surviving an FDA...
Date: Wednesday, June 26, 2013 Time: 10:00 AM PDT | 01:00 PM EDT
Instructor: Kerry Paul Potter
The purpose of the FDA inspection is a verification activity...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Preparing for and Surviving an FDA Inspection Date: Wednesday, June 26, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Register NowLocation: Online Instructor: Kerry Paul Potter Overview: The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Areas covered in the session: l Expectations of an audit l Why the FDA conducts inspections l Pre-planning and preparation activities l What to do when the investigator arrives l What documents to have ready and on hand l Assignments and responsibilities for the inspection l A review of Inspection Do s and Don ts l The Opening and Close-
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on 21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits... Documento Adobe PDF
21 CFR Part 11 and Annex 11; What you...
Pass the New Regulatory Audits
This webinar details both...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on 21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits Date: Tuesday, June 18, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 75 Minutes Register NowLocation: Online Instructor: David Nettleton Overview: This webinar details both regulations and provides details for implementing computerized systems. Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. Areas covered in the session: l Which data and systems are subject to the regulations? l What the regulations mean, not just what they say. l Avoid 483 and Warning Letters. l Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation. l Ensure data integrity, security, and protec
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Setting Up and Running a Tougher Supplier Audit Program Date: Wednesday, June 26,... Documento Adobe PDF
Setting Up and Running a Tougher...
The last few years have seen the U.
FDA come...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Setting Up and Running a Tougher Supplier Audit Program Date: Wednesday, June 26, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Register Now Location: Online Instructor: John E Lincoln Overview: The last few years have seen the U. S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based. Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. Areas covered in the session: l Regulatory "Hot Buttons" l Classify suppliers l Supplier requirements by "classification" l The site audit l Types of remote audits l Maintaining the relationship W
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Complaint Handling and Management: From Receipt to Trending Date: Thursday, June 27,... Documento Adobe PDF
Complaint Handling and Management...
Complaint Handling and Management: From Receipt to
Instructor: David R.
An effective complaint handling system is an...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Complaint Handling and Management: From Receipt to Trending Date: Thursday, June 27, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Register Now Location: Online Instructor: David R. Dills Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Areas covered in the session: l Understand how and why CAPA is tied in to product complaint investigations l Examples of tools currently being used to conduct investigations l How far and in-depth do you go with your investigations l What are current FDA "hot" buttons and trends l Benchmarks and best practices for investigations l How to become a "good" investigator and the emphasis on closed-loop investigations l Why risk-ba
Medical Device Complaint Handling Systems - Webinar By...
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Medical Device Complaint Handling Systems Date: Tuesday, June 11, 2013 Time: 10:00 AM... Documento Adobe PDF
Medical Device Complaint Handling...
Date: Tuesday, June 11, 2013 Time: 10:00 AM PDT | 01:00 PM EDT
This webinar is intended to demonstrate how to adequately establish and...
Mais GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Medical Device Complaint Handling Systems Date: Tuesday, June 11, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Register NowLocation: Online Instructor: David Lim Overview: This webinar is intended to demonstrate how to adequately establish and maintain medical device complaint handling systems. All medical device manufacturers are required to comply with the complaint handling requirements. Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in business while ensuring the safety and effectiveness of the medical device products. Areas covered in the session: l Applicable statutes and regulations for medical device complaint handling l Definitions l What to do when complaints are received? l How to process complaints. l What processes need to be in place? l