Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan: 2-Day In-Person Seminar

By: Robert J. Russell, President of RJR Consulting, Inc.
Location :- DoubleTree by Hilton San Francisco Airport, CA | Wednesday, June 20, 2018 | Thursday, June 21, 2018

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Course Description:

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
  • Senior and executive management
  • Contractors and subcontractors
  • Distributors
  • Consultants

Course Outline

Day One (8:30 AM – 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Introduction and Agenda Review
  • Lecture 1: Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
    • Program Overview
    • MDSAP Audit Process
    • MDSAP Audit Cycle
    • Country additions to MDSAP Participation
    • MDSAP Audit Procedures & Forms
  • Lecture 2: U.S. FDA Overview and Device Regulations
    • Device Classification
    • Clinical Trials / IDE
    • Licensing Pathways: 510k, De Novo, PMA
    • Human Factors and Usability Studies
    • Medical Device GMP
    • Inspection Process
    • Device Labeling
    • Combination Products
    • License Holder Responsibilities
  • Lecture 3: Canada Medical Device Regulations
    • Regulatory Authorities & Structure
    • Device Classification
    • Import / Export
    • Marketing Clearance
    • License Application Types
    • License Amendments
    • Establishment License
    • Quality System Requirements
    • Clinical Trials
    • AE Reporting
    • Inspections
    • Packaging & Labeling
    • Traceability
    • Fees
Day Two (8:30 AM – 4:30 PM)
  • Lecture 4: Brazil Medical Device Regulations
    • Country Overview & facts
    • Healthcare Authority & Structure
    • Country Establishment & Licenses
    • Requirements for Devices
    • Clinical Trials
    • Device Classification
    • Device Registration
    • Packaging & labeling Requirements
    • Medical Device Testing
    • Variations / Amendments / Renewals
    • Timelines
    • Fees
    • Post Marketing Vigilance
    • Patents & Trademarks
    • Import / Export
    • Advertising
  • Lecture 5: Australia Medical Device Regulations
    • Government Structure / Healthcare Authority
    • Medical Device Regulations
    • Country Establishment
    • GMP / Conformity Assessment
    • Essential Principles
    • Clinical Trials
    • Packaging & labeling
    • Vigilance Reporting
    • Import / Export
    • Fees
    • Timelines
  • Lecture 6: Japan Medical Device Regulations
    • Regulatory Agencies & Structure
    • Agency Consultations
    • Pharmaceutical & Medical Device Law
    • Clinical Trials
    • Business Entities / Country Establishment
    • Licensing Options
    • MAH Overview / Personnel
    • Types of medical Device Licenses
    • ICH / Japan
    • Facility Audits
    • Device Classifications
    • Device Registration
    • Device Labeling
    • Timeline / Fees
    • Cultural Considerations
  • Lecture 7: MDSAP Adverse Event Reporting / Common Themes
  • Lecture 8: Regulatory Process / Working with Global Agencies
  • Final Questions and Closure

Meet Your Instructor

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.

Venue

Location :
DoubleTree by Hilton San Francisco Airport
835 Airport Blvd,
Burlingame, CA, 94010-9949, USA

June 20-21, 2018


How to Reach

General Driving Directions:

Directions from San Francisco International Airport, CA: 4.8 mi.
  • Depart from San Francisco International Airport, CA
  • Take ramp left for US-101 South toward San Jose (2.5 mi.)
  • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
  • Turn left onto Broadway (0.2 mi.)
  • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
  • Turn left onto Airport Blvd (0.7 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from San Jose International Airport, CA: 31.1 mi.
  • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
  • Bear left toward Skyport Dr (0.3 mi.)
  • Keep straight onto Skyport Dr (0.1 mi.)
  • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
  • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
  • Directions from Metropolitan Oakland International: 27.5 mi.
    • Depart Airport Dr toward Airport Dr (0.3 mi.)
    • Turn right onto Alan Shepard Way (0.0 mi.)
    • Turn right onto John Glenn Dr (0.5 mi.)
    • Turn right onto Ron Cowan Pkwy (0.0 mi.)
    • Take ramp left for Airport Dr (0.7 mi.)
    • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
    • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
    • Take ramp right for I-880 South toward San Jose (6.7 mi.)
    • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
    • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
    • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
    • Keep straight onto Anza Blvd (0.2 mi.)
    • Turn right onto Airport Blvd (0.0 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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