ComplianceOnline

This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • What is the Medical Device Single Audit Program (MDSAP)?
  • Which Companies must have MDSAP?
  • Which Companies should have MDSAP?
  • Which Companies should postpone MDSAP?
  • What are the requirements of MDSAP?
  • How to implement MDSAP in a smart way into a quality management system according ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
  • How the MDSAP-Audit is working?
  • What is the difference between MDSAP and European Notified Body Audits?

Who will Benefit:

Life sciences companies who sell to Australia, Brazil, Canada, Japan or US will be benefited by attending this seminar:

  • CEO and top executives
  • Regulatory Affairs Managers
  • Quality Managers
  • Quality Representatives
  • Other managers, who need to deal with regulatory or quality guidelines
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration and Meet & Greet.
  • 9:00 AM - 11:00 AM: Introduction into MDSAP (What is MDSAP? Why was MDSAP created? How to attend MDSAP as medical device manufacturer?)
  • 11:00 AM - 12:00 PM: MDSAP – Management Processes and Requirements (What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 12:00 Noon - 1:00 PM: Lunch
  • 1:00 PM - 2:30 PM: Design and Development Processes and Requirements ((What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 2:30 PM - 3:00 PM: Refreshments Break.
  • 3:00 PM - 4:30 PM: Production and Service Controls ((What are the requirements? How to implement the requirements? What are the management responsibilities?)
Day 02(8:30 AM - 1:00 PM)
  • 8:30 AM - 8:59 AM: Registration and Meet & Greet.
  • 9:00 AM - 11:00 AM: Purchasing (What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 11:00 AM - 12:00 PM: Market Authorization, Communication with Authorities (Adverse Event Reporting, Field Safety Corrective Actions)
  • 12:00 PM - 1:00 PM: Questions and Answers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Frank Stein

Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

March 7-8, 2019, Zurich, Switzerland
(Registrations till November 25, 2018 - $1299)
(Registrations after November 25, 2018 - $1899)




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 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 @ customercare@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 $300 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 ($300) 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.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Zurich, Switzerland
    (Venue to be announced shortly)

    March 7-8, 2019

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Local Attractions of Zurich, Switzerland

    Kunsthaus Zurich

    Kunsthaus Zurich

    The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.

    Bahnhofstrasse

    Bahnhofstrasse

    Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.

    Zurich Zoo

    Zurich Zoo

    Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.

    Limmat River

    Limmat River

    Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.

    Fraumunster Church

    Fraumunster Church

    The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.

    Zurich Old Town

    Zurich Old Town

    Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings

    Schweizerisches Landesmuseum

    Schweizerisches Landesmuseum

    The Schweizerisches Landesmuseum (or Swiss National Museum in English) occupies an imposing neo-Gothic building, which houses a huge collection of objects documenting the Swiss peoples and their history. The collections range in date from prehistoric to modern times.

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