ComplianceOnline

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

Instructor: Robert J Russell
Product ID: 705370
  • 8
  • February 2018
    Thursday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min

Live Online Training
February 08, Thursday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

Why Should You Attend:

This 90-minute webinar is focused on understanding the Medical Device Single Audit Program (MDSAP), 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 webinar 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.

Highlights of 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 Webinar:

  • Introduction and Agenda Review
  • Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
  • U.S. FDA – Overview of Medical 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)
  • Canada – Overview of Health Canada Medical Device Regulations
  • Brazil -- Overview of ANVISA Medical Device Regulations
  • Australia – Overview of TGA Medical Device Regulations
  • Japan – Overview of PMDA Medical Device Regulations
  • Working with Country Regulators
  • Q&A Session

Who Will Benefit:

This 90-minute webinar 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 webinar 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 webinar is a must for those who are looking to apply for a medical device registration and product license in a MDSAP country. Employees who will significantly benefit by attending this training include:

  • Regulatory Affairs Personnel
  • Quality Assurance, Quality Control, and Quality Systems Professionals
  • Product Development Personnel
  • Contract Research Organizations Personnel
  • Business Management
  • Site Managers
  • Senior and Executive Management
  • Contractors and Subcontractors
  • Distributors
  • Consultants
Instructor Profile:
Robert J Russell

Robert J Russell
President, RJR Consulting, Inc

For the past 9 years, Robert J. Russell 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.

Topic Background:

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, requiring 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.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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