![Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan (Recorded)- Product Image](http://www.researchandmarkets.com/product_images/12305/12305963_500px_jpg/training.jpg)
Why Should You Attend:
This 6 hrs. webinar 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 webinar will discuss how such audits are organized, what to expect during an 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.
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.
Course Content
December 2, 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
Course Provider
Robert J. Russell,
President/CEO ,
RJR Consulting, Inc.Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 19 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices. Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
Who Should Attend
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
