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

 
  February 03, 2021  
     
 
ComplianceOnline, online event
24 February 2021


February 24, 2021 (11:00 AM TO 5:00 PM EST)

  • 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
 
 
Organized by: ComplianceOnline
Invited Speakers:

Bob is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority’s requirements and regulatory processes across Life Science products.

For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry.

 
Deadline for Abstracts: 23.2.2021
 
Registration: Register by phone or need assistance? Call +1-888-717-2436

E-mail: referral@complianceonline.com
 
 
   
 
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