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 - 6:00 PM)
  • 8:30-8:59 AM: Registration. Meet & Greet.
  • 9:00-10:00 AM: Introduction into MDSAP (What is MDSAP? Why was MDSAP created? How to attend MDSAP as medical device manufacturer?)
  • 10:00-11:00 AM: MDSAP – Management Processes and Requirements (What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 11:00-12:00 AM: Design and Development Processes and Requirements ((What are the requirements? How to implement the requirements? What are the management responsibilities?
  • 12:00-1:00 PM: Lunch
  • 1:00-2:00 PM: Production and Service Controls ((What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 2:00-03:00 PM: Purchasing (What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 3:00–3:30 PM: Refreshments Break.
  • 3:30-4:30 PM: Production and Service Controls ((What are the requirements? How to implement the requirements? What are the management responsibilities?)
  • 4::30-5:30 PM: Market Authorization, Communication with Authorities (Adverse Event Reporting, Field Safety Corrective Actions)
  • 05:30-06:00 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

$1,099.00

Seminar One Registration (USD)

March 20, 2019, Singapore
(Registrations till February 28, 2019 - $1099)
(Registrations after February 28, 2019 - $1299)

$1,249.00

Seminar One Registration (USD) (With 1 Night Stay)

March 20, 2019, Singapore




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

    Hilton Singapore
    581 Orchard Road,
    Singapore 238883, Singapore
    Tel: +65-6737-2233

    March 20, 2019

    How to Reach

    General Driving Directions:

    From Changi International Airport – 13 miles
    • Taxis are readily available to take you from Changi International Airport to the Hilton Singapore hotel.
    • The journey normally takes around 20 minutes from the airport to the hotel forecourt.

    Other Transportation:

    Bus Station
    • Many buses to the city center from Changi International Airport stop on Orchard Road, where the Hilton Singapore hotel is located. The journey normally takes around an hour.
    Train Station
    • The train journey from the airport to Orchard MRT Station, the underground station nearest to Hilton Singapore hotel, normally takes around 40 minutes.

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

    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 Singapore

    Singapore Zoo

    Singapore Zoo

    Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.

    Night Safari

    Night Safari

    The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.

    Universal Studios Singapore

    Universal Studios Singapore

    Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!

    Singapore Flyer

    Singapore Flyer

    The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.

    Underwater World, Singapore

    Underwater World, Singapore

    Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.

    Boat Quay

    Boat Quay

    Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.

    Sentosa Island

    Sentosa Island

    Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.

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

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