BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T104200Z UID:60e5cb6f-49db-4aa9-81d8-0f78f2c83fd9 DTSTART:20210224T083000 DTEND:20210225T083000 CLASS:PRIVATE DESCRIPTION:\n
Global Medical Device Regulations continue to evolve\, as de vices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market o f innovative products and assist patients needing access to life-saving pr oducts and technologies. Government Regulatory Authorities\, needing to be come more efficient with their time\, are looking for ways to better use t heir internal resources without compromising safety in products\, which be come marketable. One such example is the Medical Device Single Audit Progr am [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 cou ntries: U.S. Canada\, Brazil\, Australia and Japan.
\n\nThis two-day seminar is focused on understanding the Medical Device Single Audit Program\, the scope of the program\, how t o apply\, the Authorized Organizations\, the rating system developed and w hat 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 documen t movement and timeline expectations in receiving the facility&rsquo\;s ce rtificate.
\n\nThe key Regulato ry Requirements for Medical Devices will also be covered for the participa ting MDSAP Countries of: U.S.\, Canada\, Brazil\, Australia and Japan.
\nThis two-day seminar will provide inva luable assistance to all personnel in the Medical Device industry\, who ha ve a stake in expanding their business into a MDSAP participating country and for those interested in more information about MDSAP and how it may ap ply to them.
\n\nThis seminar w ill be particularly useful for those involved in research and development\ , document creation for regulatory submission\, data handling and for thos e conducting/monitoring/coordinating clinical investigation\, performing r isk management and post-market vigilance/surveillance. This seminar is a m ust for those who are looking to apply for a medical device registration a nd product license in a MDSAP country.
\n\nThose employees working in the following roles will significan tly benefit by attending:
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