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

$1,999.00

Seminar One Registration

March 5-6, 2020, San Diego, CA

$10,195.00

Special Group Discount Register for Six attendees

March 5-6, 2020, San Diego, CA




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.

Online using Credit card

$1,899.00

Seminar One Registration

July 16-17, 2020, Tampa, FL
(For Registrations till March 25, 2020 - $1899)
(For Registrations after March 25, 2020 - $2299)

$8,995.00

Special Group Discount Register for Six attendees

July 16-17, 2020, Tampa, FL
(For Registrations till March 25, 2020 - $8995)
(For Registrations after March 25, 2020 - $13795)




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.

1

San Diego, CA
March 5-6, 2020

Hotel

The University Club
atop Symphony Towers
750 B Street Suite 34th Floor,
San Diego, CA 92101, USA

Tel: +1-619-234-5200

How to Reach

General Driving Directions:

Driving Directions from San Diego International Airport: 3.3 Miles
  • Head northwest on Airport Terminal Rd
  • Keep right to stay on Airport Terminal Rd
  • Continue straight and turn left onto N Harbor Dr
  • Turn left onto W Ash St
  • Use the left lane to turn right onto Kettner Blvd
  • Turn left onto W A St, destination will be on the right

Nearby Hotel Options for Attendees:

  • Kimpton Palomar San Diego | 1047 Fifth Ave, San Diego, CA 92101 | .03 mile ( 5 min walk)
  • Courtyard Marriott Downtown San Diego | 530 Broadway, San Diego, CA 92101| .03 mile ( 5 min walk)
  • TownePlace Suites by Marriott San Diego Downtown | 1445 Sixth Ave, San Diego, CA 92101 | .04 mile ( 7 min walk)

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.

2

Tampa, FL
July 16-17, 2020
(Venue to be announced shortly)

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 San Diego, CA

San Diego Cabrillo National Monument

San Diego Cabrillo National Monument

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line.

Sea Creatures at Birch Aquarium

Sea Creatures at Birch Aquarium

Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

Legoland

Legoland

Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

San Diego Zoo Safari Park

San Diego Zoo Safari Park

The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

Coronado Island

Coronado Island

Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

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.

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

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