ComplianceOnline

Course Description:

FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.

It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems. Seminar instructor Harvey Rudolph, Ph.D., one of the authors of ISO 14971 and a 25 year veteran of FDA, will also provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.

Seminar Instructor Dr. Harvey Rudolph is an ex-FDA official having spent 25 years with FDA and one of the authors of ISO 14971. He will provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.




Learning Objectives:

  • To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
  • To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
  • To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
  • To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
  • To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
  • To provide attendees with the Dos and Don'ts for an effective and efficient risk management system


Who will benefit:

  • Project managers
  • Quality managers and staff
  • R & D managers and staff
  • Regulatory and compliance managers and staff
  • Anyone with risk management responsibilities


Topic Background:

The 3rd edition of IEC 60601 adds further fuel to the fire with the requirement that electro-medical device manufacturers have a risk management process in place conforming to ISO 14971. Manufacturers that market devices in the European Union have found additional requirements for their risk management activities as detailed in EN/ISO 14971:2012.





Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Introduction
    • What is risk management?
    • Global requirements
    • ISO 14971
    • New European requirements and EN/ISO 14971:2012
  2. Risk management essentials and requirements
    • Risk management philosophy
    • Role of Management
  3. Establishing a risk management policy
    • Required inputs
    • Developing a workable policy (Exercise)
  4. Risk management planning
    • Necessary elements
    • Relationship with quality planning
  5. Risk acceptability criteria/constructing a risk chart
    • Defining the product
    • Measuring risk (Exercise)
    • How to establish risk acceptability criteria
    • EN/ISO 14971:2012 requirements
    • Construct a practical example
  6. Preliminary analysis
    • Safety analysis (Exercise)
    • Hazards and hazardous situations
    • Identifying hazards and hazardous situations (Exercise)
  7. Risk Analysis tools
    • What's available
    • Use and utility of tools (Exercise)
  8. Estimating risk
    • Quantitative and qualitative risk estimation (Exercise)
    • Pitfalls such as software
    • Practical example (Exercise)
  9. Using standards and risk management
    • New guidance from ISO
  10. Risk Evaluation and Risk Control
    • Using a risk chart (Exercise)
    • Use of ALARP
    • Option analysis for risk control

  1. Risk Control (continued)
    • The iterative process
    • Practical example (Exercise)
    • Verification, residual risk and completeness
    • Satisfying EN/ISO 14971:2012
  2. Risk/benefit analysis
    • EN/ISO 14971:2012 requirement
    • How to do it?
  3. Overall residual risk & the risk management report
    • New ISO guidance on evaluating overall residual risk
    • Content and use of the Risk Management Report
  4. Assessing production & post-production information
    • What are the requirements?
    • What you need to do
    • New guidance from ISO
  5. Wrap up
    • Risk management philosophy
    • Risk management and the quality management system
    • Helpful hints




Meet Your Instructor

Harvey Rudolph
HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that standard and is working on the new ISO risk management guidance document.

His 37 years experience with medical devices include 25 years at FDA, where he held a variety of positions and retired as deputy director of the medical device laboratory. He also worked for seven years at Underwriters Laboratory, where he was the global program manager for medical devices developing programs to help clients deal with the global medical device environment.

He brings a wealth of knowledge and practical experience to this risk management workshop, having trained and consulted for numerous large and small companies throughout the world.





Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.







Local Attractions

The Brandenburg Gate is a former city gate, rebuilt in the late 18th century as a neoclassical triumphal arch, and now one of the most well-known landmarks of Germany. The gate is the monumental entry to Unter den Linden, the renowned boulevard of linden trees, which formerly led directly to the city palace of the Prussian monarchs. It was commissioned by King Frederick William II of Prussia as a sign of peace and built by Carl Gotthard Langhans from 1788 to 1791. Throughout its existence, the Brandenburg Gate was often a site for major historical events and is today considered a symbol of the tumultuous history of Europe and Germany, but also of European unity and peace.




The Berlin Wall was a barrier constructed by the German Democratic Republic (GDR, East Germany) starting 13 August 1961, that completely cut off (by land) West Berlin from surrounding East Germany and from East Berlin. The barrier included guard towers placed along large concrete walls, which circumscribed a wide area (later known as the "death strip") that contained anti-vehicle trenches, "fakir beds" and other defenses. The wall served to prevent the massive emigration and defection that marked East Germany and the communist Eastern Bloc during the post-World War II period. The physical wall was primarily destroyed in 1990. The fall of the Berlin Wall paved the way for German reunification, which was formally concluded on 3 October 1990.




The Reichstag building is a historical edifice in Berlin, Germany, constructed to house the Imperial Diet of the German Empire. It was opened in 1894 and housed the Diet until 1933, when it was severely damaged in a fire. After World War II, the building fell into disuse. The ruined building was made safe against the elements and partially refurbished in the 1960s, but no attempt at full restoration was made until after German reunification on 3 October 1990, when it underwent a reconstruction led by architect Norman Foster. After its completion in 1999, it once again became the meeting place of the German parliament: the modern Bundestag.




Museum Island is the name of the northern half of an island on the Spree River in the central Mitte district of Berlin, Germany, the site of the old city of Cölln. It derives its name from its five internationally significant museums, all part of the Berlin State Museums: the Altes Museum, the Neues Museum, the Alte Nationalgalerie, the Bode Museum, and the Pergamon Museum. In 1999, the museum complex was added to the UNESCO list of World Heritage Sites.




The Topography of Terror is an outdoor and indoor history museum in Berlin. It is located on Niederkirchnerstrasse, formerly Prinz-Albrecht-Strasse, on the site of buildings which during the Nazi regime were the headquarters of the Gestapo and the SS, the principal instruments of repression during the Nazi era. The first exhibitions of the site took place in 1987 as part of Berlin's 750th anniversary. The cellar of the Gestapo headquarters, where many political prisoners were tortured and executed, were found and excavated. The site was then turned into a memorial and museum, detailing the history of repression under the Nazis. The new exhibition and documentation building and the redesigned historic grounds were opened to the public on May 7, 2010.




Deutsches Technikmuseum Berlin (German Museum of Technology) in Berlin, Germany is a museum of science and technology, and exhibits a large collection of historical technical artifacts. The museum's main emphasis originally was on rail transport, but today it also features exhibits of various sorts of industrial technology. Recently, it has opened both maritime and aviation exhibition halls. The museum also contains a science center called Spectrum. The museum’s collection includes an extensive railway collection opened in 1987/88 in the original 19th century roundhouses of the Anhalter Bahnhof locomotive depot. A large aviation section beside the C-47 houses numerous aircrafts from the single Jeannin Stahltaube to a LufthansaJunkers Ju 52 and an Arado Ar 79. On May 15, 2002, a special exhibition opened which featured the inventions of computer pioneer Konrad Zuse, including a replica of the Z1.




The Victory Column is a monument designed by Heinrich Strack after 1864 to commemorate the Prussian victory in the Danish-Prussian War. By its inauguration on 2nd September 1873, Prussia had also defeated Austria in the Austro-Prussian War (1866) and France in the Franco-Prussian War (1870–71), giving the statue a new purpose. Different from the original plans, these later victories in the so-called unification wars inspired the addition of the bronze sculpture of Victoria, 8.3 metres high and weighing 35 tonnes, designed by Friedrich Drake. Berliners have given the statue the nickname Goldelse. The Victory Column is a major tourist attraction in the city of Berlin and opens daily: 9:30 a.m. – 6:30 p.m. (April – October), and 9:30 a.m. – 5:30 p.m. (November – March).






We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading