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.
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.
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The New Jersey Performing Arts Center
The New Jersey Performing Arts Center (NJPAC) has garnered national attention during its first 11 seasons, serving as a model for programming, audience diversity, education initiatives and the catalytic role it has played in returning nightlife and economic activity to NJ's largest urban community.
The facility, initially served the needs of the New Jersey Symphony Orchestra, the New Jersey State Opera and other state dance and theater companies. In addition to that, NJPAC routinely hosts national and international performers plus touring companies and has become a world-class entertainment destination.
The Newark Museum
The Newark Museum in Newark, the state's largest city, offers outstanding collections, exhibitions, programs and educational resources in its multibuilding campus in the heart of Newark’s Downtown/Arts District.
Founded in 1909, the Newark Museum underwent an extensive four-year, $23 million renovation and expansion program, which was completed in 1989. The design, by world-famous architect Michael Graves, garnered the American Institute of Architects’ Honor Award. The museum complex weaves together 80 galleries of art and science, a miniature zoo, planetarium, gift shops, café, auditorium, sculpture garden, schoolhouse and the Ballantine House, a restored 1885 mansion that is a National Historic Landmark.
The Ironbound District
Dining defines The Ironbound District as a culinary experience par excellence. It's an adventure enriched by quality service, cultural authenticity and delicious infinite variety. Visitors can choose from the District's more than 170 restaurants and eateries that serve lunch or dinner in an excursion into world-class international cuisine.
Predominantly Portuguese, Spanish and Brazilian, flavored by Mexican and Central and South American influences, the district also offers an abundance of fresh seafood, a scintillating selection of meat and chicken dishes and regional favorites are served up in generous portions and at affordable prices.
Cathedral Basilica of the Sacred Heart Concert Series
French Gothic cathedral famous for its stained glass. Organ recitals.
Branch Brook Park
The park's more than 2,000 cherry trees exceed both the variety and number found in Washington, D.C., Each spring, the park is home to the annual Cherry Blossom Festival. Branch Brook Park is the first county park to be opened for public use in the United States.