Course Description:
It is critical to understand the applicable regulations/requirements and apply them appropriately to each phase of product life cycle. Anyone can read and understand regulations or requirements from the source(s), but when it comes to interpretation and application, they are invisible. This course makes this part of the compliance process visible to participants.
This two days interactive course on medical device regulations will provide a good understating of requirements in US, Canada, Europe, Australia and major Asian countries and how they affect the total lifecycle, especially a company’s products.
Learning Objectives:
After completing this course on medical device regulatory requirements, the attendee will be able to:
- Define a typical Total Product Life Cycle (TPLC) of a medical device from the regulator’s point of view
- Explain each phase of TPLC and manage involved tasks and activities
- Overview of medical device regulations and requirements: United States, Canada, Europe, Australia and major Asian countries
- Identify common elements of regulatory framework based on acquired knowledge
- Develop and determine phases of TPLC of medical devices
- Determine and plug all applicable regulations/requirements to each phase of TPLC
- Apply risk management principles and techniques throughout the TPLC
- Build company-wide Continuous Compliance Culture (CCC) with ease and confidence
Who will benefit:
This interactive course is designed for both technical and non-technical people who are involved in the design, development, manufacturing, marketing, and distribution of medical devices. The people who are involved and responsible for interactions with external partners, hospitals, clinics, healthcare professionals, customers and regulatory authorities will get maximum benefits.
- Senior Management (Director, Associate Director or VP level)
- Sales and Marketing
- Research & Development (R&D)
- Product Design & Development
- Regulatory Affairs Professionals
- Quality Assurance
- Key players in Manufacturing /Production
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM Welcome and Introduction Session 1: 09:00 AM – 10:30 AM Total Product Life Cycle
Morning Break: 10:30 AM – 10:45 AM Session 2: 10:45 AM – 12:15 PM An overview of applicable U.S. medical device regulatory requirements to TPLC Lunch Break: 12:15 PM – 1:15 PM Session 3: 1:15 PM – 2:45 PM An overview of applicable Canadian medical device regulatory requirements to TPLC Afternoon Break: 02:45 PM – 03:00 PM Session 4: 03:00 PM – 04:30 PM An overview of applicable European medical device regulatory requirements to TPLC |
Session 5: 8:30 AM – 10:30 AM An Overview of applicable Australian medical device regulatory requirements to TPLC Morning Break: 10:30 AM – 10:45 AM Session 6: 10:45 AM – 12:15 PM An overview of applicable select major Asian countries’ medical device regulatory requirements to TPLC Lunch Break: 12:15 PM – 1:15 PM Session 7: 1:15 PM – 2:45 PM Mapping global regulations and regulatory requirements to each phase Afternoon Break: 02:45 PM – 03:00 PM Session 8: 03:00 PM – 04:30 PM Exercise: Mapping applicable medical device regulations and requirements to your product(s) Questions & answers (if any) |
Meet Your Instructor
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Subhash R Patel Regulatory Affairs & Quality Compliance Consultant at MD Reg Consulting, LLC Subhash Patel is a seasoned and well-accomplished Regulatory Affairs and Quality professional with over 27 years of Global Regulatory Affairs experience in highly regulated medical device industry. Mr. Patel is a founder and owner of MD Reg Consulting, LLC offering services to medical device industry clients. He started his career as a Quality Engineer and climbed corporate ladder to the Director of Corporate Regulatory Affairs/QA of Fortune 500 medical device companies. During his professional journey he gathered wealth of practical knowledge and working experience with the global laws, regulations, and regulatory requirements for medical devices. His passion is to learn new challenges and share his knowledge and experience with others to succeed. He is Regulatory Affairs Certified (RAC) and also honored as a RAPS Fellow by the Regulatory Affairs Professional Society (RAPS). He holds professional certificates in Medical Devices Regulatory Affairs Program, ASQ-Certified Quality Auditor (CQA) and ASQ-Certified Quality Engineer (CQE). His educational background includes BS degree in Mechanical Engineering and also BS degree in Chemistry. |
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USA
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Venue
Hotel:Boston Marriott Copley Place
110 Huntington Ave
Massachusetts 02116 USA
October 16-17, 2014
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View Larger Map |
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How to Reach
General Driving Directions:
Driving Directions from Boston Logan International Airport – BOS: 3.2 mile(s) NE- Follow signs for Boston/Sumner tunnel.
- Pay the toll and stay in the right lane in the tunnel.
- Follow signs for Exit 26/Storrow Drive. After you emerge from the tunnel, take the second left exit to Copley Square/Back Bay.
- At the first light, turn right onto Beacon St. Follow Beacon St. for 4 blocks and make a left on to Exeter St.
- After 5 lights, Exeter St. ends at Huntington Ave. Turn right onto Huntington Ave.
- At the first light, under the sky bridge, make a U-turn to the left. The hotel entrance will be immediately on your right.
Other Transportation:
Bus Station- South Station: 1.2 mile(s) E
Subway Station
- Back Bay Station: 0.2 mile(s) E
Train Station
- Back Bay / Copley Station: 0.2 mile(s) E
- North Station: 2 mile(s) NE
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
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Local Attractions
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
North End
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.
