Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 25909
Event :Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes 2017

Dates :Thursday October 12th, 2017 - Friday October 13th, 2017

Location :Courtyard Arlington Crystal City/Reagan National Airport
2899 Jefferson Davis Hwy, Arlington, VA 22202, USA
22202 Washington, DC, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Course "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

 

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.

 

Why you should attend:

 

This two-day seminar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program. The seminar will discuss how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility's certificate.

The key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.

 

Areas Covered in the Session:

 

  • The Medical Device Single Audit Program (MDSAP)
  • Device Classification
  • Licensing Pathways
  • Medical Device GMP
  • Inspections
  • Device Labeling
  • License Holder Responsibilities
  • Timelines and Fees
  • Country Specific Cultural Considerations and Challenges
  • Adverse Event Reporting

 

Who Will Benefit:

 

This two-day seminar will provide invaluable assistance to all personnel in the Medical Device industry, who have a stake in expanding their business into a MDSAP participating country and for those interested in more information about MDSAP and how it may apply to them.

This seminar will be particularly useful for those involved in research and development, document creation for regulatory submission, data handling and for those conducting/monitoring/coordinating clinical investigation, performing risk management and post-market vigilance/surveillance. This seminar is a must for those who are looking to apply for a medical device registration and product license in a MDSAP country.

 

 

Agenda:

 

Day 1 Schedule

 

Lecture 1:

Introduction and Agenda Review

Lecture 2:

Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report

Lecture 3:

U.S. FDA Overview and Device Regulations

  • Device Classification, Licensing Pathways, Human Factors and Usability Studies, Medical Device GMP, Inspection Process, Device Labeling, Combination Products, License Holder Responsibilities
  • (NOTE: Each country session will follow a similar format to the information above)

Lecture 4:

Canada Medical Device Regulations

Lecture 5:

Brazil Medical Device Regulations

 

Day 2 Schedule

 

Lecture 1:

Australia Medical Device Regulations

Lecture 2:

Japan Medical Device Regulations

Lecture 3:

Adverse Event Reporting

Lecture 4:

Regulatory Process

Lecture 5:

Final Questions and Closure

 

 

Speaker

Robert Russell

President, RJR Consulting, Inc. 

 

For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

 

 

 

Location:  Washington, DC Date:  October 12th & 13th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:    Courtyard Arlington Crystal City/Reagan National Airport   2899 Jefferson Davis Hwy, Arlington, VA 22202, USA

 

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 31, Early Bird Price: $1,295.00 From September 01 to October 10, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00    $12,950.00 You Save: $5,828.00 (45%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link -http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901160SEMINAR?doctorama-October-2017-SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

Location

Map and directions
Conference address :
Courtyard Arlington Crystal City/Reagan National Airport
2899 Jefferson Davis Hwy, Arlington, VA 22202, USA
22202 Washington, DC
United States
Map and directions

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Announcer

GlobalCompliancePanel
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and [...]

Other events from GlobalCompliancePanel

Presentation sheet from GlobalCompliancePanel

Details

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes 2017 Medicine - Pharmacy - Veterinary
medical device single audit program, list of medical device companies, fda regulations medical devices, mdsap, medical device regulations, mdsap audit checklist
Everyone, This two-day seminar will provide invaluable assistance to all personnel in the Medical Device industry, Who have a stake in expanding their business into a MDSAP participating country and for those interested in more information about MDSAP and how it may apply to them. This seminar will be particularly useful for those involved in research and development, Document creation for regulatory submission, Data handling and for those conducting/monitoring/coordinating clinical investigation, Performing risk management and post-market vigilance/surveillance. This seminar is a must for those who are looking to apply for a medical device registration and product license in a MDSAP country.
-- -- --
English

Other

For more information on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes 2017, plsase contactr GlobalCompliancePanel

To display announcer website, download the booklet or brochure, obtain a letter of invitation, you must be logged

Log to my account
Register on Doctorama


Recommend this event