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.
Topics to be Discussed:
Areas Covered in the Webinar:
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:
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.
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.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
PAYMENT METHOD: 100% Secure Transaction