Medical Device Registration and Listing | Japan, Australia

Start Date : February 7, 2018
End Date : February 8, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Location :
Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Website

Description







 


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:


 



 


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



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:   Zurich, Switzerland Date:   February 7th & 8th, 2018 and Time: 9:00 AM to 6:00 PM


Venue: Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50


Price:


 


 


Price: $1,695.00 (Seminar Fee for One Delegate)


Register now and save $200. (Early Bird)


Until January 15, Early Bird Price: $1,695.00 From January 16 to February 05, Regular Price: $1,895.00


Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*


Register for 10 attendees   Price: $9,322.00 $16,950.00 You Save: $7,628.00 (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=900990SEMINAR?meetings4docs-February-2018-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


 


 




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Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/


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