GlobalCompliancePanel Your Gateway to Regulatory Compliance
2-day In-person Seminar on
Applying ISO14971 and IEC62304 - A guide to practical Risk
Management
Location: San Diego | August 01 & 02, 2013 | 9 AM to 6 PM PDT
Venue: TBD
Location: Philadelphia | November 7th & 8th, 2013 | 9 AM to 6 PM EDT
Venue: TBD
Register Now
By Markus...
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GlobalCompliancePanel Your Gateway to Regulatory Compliance 2-day In-person Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management Location: San Diego | August 01 & 02, 2013 | 9 AM to 6 PM PDT Venue: TBD Location: Philadelphia | November 7th & 8th, 2013 | 9 AM to 6 PM EDT Venue: TBD Register Now By Markus Weber Price: $1,295. 00 (for 1 attendee) Register now and save $200. (Early Bird) Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant s RAC recertification upon full completion. Overview: This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented. Agenda: Day 1 : 1st August 2013 Day 2 : 2nd August 2013 Lecture 1: (ISO 14971): Risk Management Planning Risk Management Life Cycle Hazar
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GlobalCompliancePanel Your Gateway to Regulatory Compliance
2-day In-person Seminar on
Effective Complaint Handling, Medical Device
Reporting and Recalls
Location: Boston, MA | July 25th & 26th, 2013 | 9 AM to 6 PM EDT
Venue: Courtyard Boston Logan Airport
Address: 225 William F.
McClellan Highway Boston, Massachusetts 02128 USA...
Mais
GlobalCompliancePanel Your Gateway to Regulatory Compliance 2-day In-person Seminar on Effective Complaint Handling, Medical Device Reporting and Recalls Location: Boston, MA | July 25th & 26th, 2013 | 9 AM to 6 PM EDT Venue: Courtyard Boston Logan Airport Address: 225 William F. McClellan Highway Boston, Massachusetts 02128 USA Register Now By David R. Dills Price: $1,295. 00 (for 1 attendee) Register now and save $200. (Early Bird) 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. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. Agenda: Day 1 : 25th July 2013
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GlobalCompliancePanel Your Gateway to Regulatory Compliance
2-day In-person Seminar on
Mastering Biofilm Control, Monitoring, Validation and Excursion
Investigations of Pharmaceutical Water Systems
Location: Orange County | June 6th & 7th, 2013 | 9 AM to 6 PM PDT
Venue: DoubleTree Suites by Hilton Hotel Anaheim Resort - Convention...
Mais
GlobalCompliancePanel Your Gateway to Regulatory Compliance 2-day In-person Seminar on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems Location: Orange County | June 6th & 7th, 2013 | 9 AM to 6 PM PDT Venue: DoubleTree Suites by Hilton Hotel Anaheim Resort - Convention Center Address: 2085 S. Harbor Blvd. , Anaheim, California, 92802, USA Register Now By Teri C. Soli Price: $1,295. 00 (for 1 attendee) Register now and save $200. (Early Bird) Course "Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant s RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The
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GlobalCompliancePanel Your Gateway to Regulatory Compliance
2-day In-person Seminar on
Software Validation for the New FDA Inspections
Location: San Diego | September 19th & 20th, 2013 | 9 AM to 6 PM
PDT
Venue: Doubletree Hotel San Diego Downtown
Address: 1646 Front Street, San Diego, California, 92101, USA
Register Now
By David...
Mais
GlobalCompliancePanel Your Gateway to Regulatory Compliance 2-day In-person Seminar on Software Validation for the New FDA Inspections Location: San Diego | September 19th & 20th, 2013 | 9 AM to 6 PM PDT Venue: Doubletree Hotel San Diego Downtown Address: 1646 Front Street, San Diego, California, 92101, USA Register Now By David Nettleton Price: $1,295. 00 (for 1 attendee) Register now and save $200. (Early Bird) Overview: l This course will teach you how to reduce software validation costs by as much as two thirds. l It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation. l The course is highly interactive, using real life examples and proven techniques. l You will learn how to use electronic records and electronic signatures to maximize productivity. l This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
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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...
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
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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...
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
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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...
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
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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...
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
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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,...
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
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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...
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-
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Wilmington, Estados Unidos
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