One-Day Virtual Seminar

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

BY: Robert J. Russell,

President of RJR Consulting, Inc

September 28, 2021
(11:00 AM to 5:00 PM EDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

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. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.

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 6 Hrs. 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 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
  • Senior and executive management
  • Contractors and subcontractors
  • Distributors
  • Consultants
Day 01(11:00 AM to 5:00 PM EDT)
  • Introduction and Agenda Review
  • Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
  • U.S. FDA – Overview of Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
    • 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 and Regulatory Processes throughout the Product Life Cycle
  • Brazil -- Overview of ANVISA Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
  • Australia – Overview of TGA Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
  • Japan – Overview of PMDA Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
  • Working Effectively with In-Country Regulatory Agencies
  • Q&A Session
Robert J. Russell
Robert J. Russell President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.

Register Now

Online using Credit card

$1,099.00

(One Dial-in One Attendee)

September 28, 2021, Virtual Seminar

$5,595.00

Group-Max. 10 Attendees

September 28, 2021, Virtual Seminar


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