ComplianceOnline

Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”

This two day interactive course on FDA regulations for medical devices will:

  • Cover more than just the Quality Management System
  • Provide an overview of regulations and how they fit together
  • Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
  • Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
  • Teach the current device marketing regulations
  • Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • Learn the law, regulations, and policies that FDA applies for medical device
  • Understand the requirements to market a medical device in the US including device classification and conformity assessment paths
  • Understand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US market
  • Learn how UDI will affect medical devices and how to prepare for implementation
  • Understand the rules for Medical Device Reports (MDRs) and their relationship to complaints
  • Understand which devices must be tracked and how to set up and audit the system
  • Learn about correcting devices already shipped and when to report to FDA
  • Learn the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
  • Learn about inspectional observations and how to respond to a Form 483
  • Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered

Who will Benefit:

This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain:

  • Quality managers
  • Quality engineers
  • Quality assurance and quality control
  • Regulatory affairs managers
  • Regulatory affairs professionals
  • R&D managers
  • R&D engineers
  • Product design and development
  • Operations managers
  • Production managers and supervisors
  • Manufacturing engineers
  • Risk managers
  • Complaint system team members
  • CAPA team members
  • Device marketing personnel

Topic Background:

In the US, medical devices organization uses risk classes and panels. Devices fall under regulations and product codes that determine the available conformity assessment paths and provide requirements for specific cases.

The Quality System Regulation, in Part 820, provides the quality management system required for medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc. After release, a device is subject to a variety of other requirements ranging for complaint management to medical device reports to recalls. Each of these requirements is in a separate part of the regulations.

This two day highly interactive seminar will provide attendees a comprehensive view of the U.S. medical device regulatory requirements and will help them understand the whole picture and provide them with the effective implementation techniques for their organizations.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Legal and Regulatory Organization
    • Laws
    • Regulations
    • Guidance
    • Recognized Consensus Standards
    • FDA Organizational Structure
  • Medical Device Classification
    • Device Classes
    • Device Panels
    • Device Regulations
    • Product Codes
  • Premarket Activities, Registration, and Listing
    • Clearing devices, the 510(k) paradigm
    • Approving devices, the PMA paradigm
    • Establishment registration
    • Device listing
  • Management Controls
    • Quality Policy and Objectives
    • Management Review
    • Internal Quality Audits
  • Design Controls
    • Input
    • Output
    • Design Verification
    • Design Validation
    • Risk Management
    • Design Review
    • Design Records
  • Corrective and Preventive Actions
    • Distinguish among Correction, Corrective Action, and Preventive Action
    • Applying statistical methods to reveal issues
    • Implementation
  • Medical Device Reports (MDRs)
    • Linking Complaints and MDRs
    • When to report
    • What to report
  • Corrections and Removals
    • What they are
    • When to report
    • When to keep records, but not report
  • Medical Device Tracking
    • Determining if a device is tracked
    • Maintaining the database
    • Auditing the database
Day 02(8:30 AM - 4:00 PM)


  • Unique Device Identification
    • The regulation
    • Implementation issues
  • Production and Process Controls
    • Control of IM&TE
    • Equipment maintenance
    • Process validation
    • Software in production and the QMS
  • Material Controls
    • Purchasing
    • Handling and Storage of Material
  • Records, Documents, and Change Controls
    • Device Master Record
    • Device History Record
    • Quality System Record
    • The records FDA Investigators should not examine
  • General Records
    • Maintenance of Record
    • Record Retention Period
    • Storage of Record
  • Electronic Records
    • The role of Part 11
    • Practical issues from the guidance document
  • Statistical Techniques
    • Determining and documenting statistical techniques
    • Special considerations for sampling plans
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Stephanie Harrell

Stephanie Harrell
Consultant, ProPharma Group
(Ex-FDA Investigator)

Stephanie Harrell, B.S. has more than 13 years of experience in combined Food and Drug Administration (FDA) regulated industry inspections and consulting with experience in both the pharmaceutical and medical device industries including supplier audits. Ms. Harrell has both conducted and provided training on such topics as managing quality systems, regulatory inspections and audit preparation. She is an ex FDA investigator and speaker at numerous FDA regulated industry conferences. She also has an extensive background which includes healthcare industry consulting and training. Stephanie is passionate about contributing her knowledge to companies for the preparation skills needed for FDA inspections and has a teaching style that is interactive to bring the information to life and help learners generalize information across their various roles and jobs.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,899.00

Seminar One Registration

July 16-17, 2020, Tampa, FL
(For Registrations till July 5, 2020 - $1899)
(For Registrations after July 5, 2020 - $2299)

$8,995.00

Special Group Discount Register for Six attendees

July 16-17, 2020, Tampa, FL
(For Registrations till July 5, 2020 - $8995)
(For Registrations after July 5, 2020 - $13795)




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location :

Tampa, FL
(Venue to be announced shortly)

July 16-17, 2020

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Tampa, FL

Museum of Science

Museum of Science & Industry (MOSI)

More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.

Salvador Dali Museum

Salvador Dali Museum

Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.

Tampa Museum of Art

Tampa Museum of Art

Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.

Craftsman House

Craftsman House

Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

Adventure Island

Adventure Island

Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.

Busch Gardens

Busch Gardens

At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.

Florida Aquarium (The)

Florida Aquarium (The)

The Florida Aquarium gives visitors an all-access pass to the mysteries of the deep. Observe seahorses, lobsters, colorful fish, moray eels, gators, river otters, Australian sea dragons and many more. If you're feeling truly adventurous, take advantage of the "Swim with the Fishes" or "Dive with the Sharks" programs (advance reservations required). Kids will love the wide range of colorful and fun-filled interactive displays. The aquarium also sponsors ecotours aboard a 64-foot catamaran, affording patrons an opportunity to get even more up-close-and-personal with the sea. See website for complete list of attractions, calendar of events and more.

John's Pass Village

John's Pass Village

This scenic village with its nautical heritage and waterfront location offers an assortment of shops, boutiques, restaurants, water sports and entertainment. Located near the sands of Madeira Beach, John's Pass Village is renowned throughout the Bay Area as a site of good crafts and artisans, as well as casually comfortable seafood eateries. Weekends, the Village puts its best fin forward with street shows that include plenty of musical entertainment. From its boardwalk and marina, you can enjoy a free dolphin watch or take off aboard small cruise ships and fishing charters.

Lowry Park Zoo

Lowry Park Zoo

Tampa's first zoo can trace its history back to the 1930s. In 1957, this collection of animals and birds was moved to its current location. Recognized as the "Number One Family-Friendly Zoo in the U.S." by Child magazine, Lowry Park Zoo features 2,000 animals on 56 acres of lush, natural habitats comprising seven main exhibit areas: Asian Gardens, Primate World, Free-Flight Aviaries, Florida Boardwalk, Florida Manatee and Aquatic Center, Wallaroo Station children's zoo, and Safari Africa. Gift shops, refreshment stands and cafes are located throughout the park.

Moccasin Lake Nature Park

Moccasin Lake Nature Park

If you've wondered how sun and wind supply power and water and how a host of other things work, this is the spot to find out. This environmental and educational center located at a 50-acre park is highly recommended not only for its low price, but also for its fine educational offerings. You can see a lake, upland forest and wetlands environment here and spot most of the plant and animal species native to this area. A mile-long nature trail winds through the park and an Interpretative Center features wildlife exhibits, displays, information, a classroom and a laboratory.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading