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Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

ComplianceOnline

Thursday, November 16, 2017 at 8:30 AM - Friday, November 17, 2017 at 4:30 PM (EST)

Medical Device Single Audit Program [MDSAP]...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early bird offer)
For Registrations till September 10, 2017 - $1699
Ended $1,699.00 $19.95
Seminar One Registration Nov 16, 2017 $1,899.00 $19.95

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Event Details

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.

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.

Learning Objectives:

  • 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.

Those employees working in the following roles will significantly benefit by attending:

  • Regulatory Affairs
  • Quality assurance, quality control, and quality systems
  • Product development personnel
  • Contract research organizations
  • Business management
  • Site managers

 

For Registrationhttp://www.complianceonline.com/medical-device-single-audit-program-mdsap-implementation-regulatory-processes-us-canada-brazil-australia-japan-seminar-training-80493SEM-prdsm?channel=eventbrite          

 

Note: Use coupon code  REFERRAL10  and get 10% off on registration.

Have questions about Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan? Contact ComplianceOnline

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When & Where


Boston

Boston, MA

Thursday, November 16, 2017 at 8:30 AM - Friday, November 17, 2017 at 4:30 PM (EST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on:

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
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