A Comprehensive View of FDA Regulations for Medical Devices: 2 – Day In-Person Seminar

By: Stephanie Harrell, Consultant, ProPharma Group (Ex-FDA Investigator)
Location :- The University Club atop Symphony Towers San Diego, CA | Thursday, March 5, 2020 | Friday, March 6, 2020

We need the below information to serve you better

Course Description:

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

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.

Course Outline

Day One (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 Two (8:30 AM – 04:00 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
  • 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

Meet Your Instructor

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.

Venue

Location :

The University Club atop Symphony Towers
750 B Street, Suite 3400,
San Diego, CA 92101, USA
Tel: +1-619-234-5200

March 5-6, 2020



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 | $190/night +tax | 1047 Fifth Ave, San Diego, CA 92101 | .03 mile ( 5 min walk)
  • Courtyard Marriott Downtown San Diego | $208+tax |530 Broadway, San Diego, CA 92101| .03 mile ( 5 min walk)
  • TownePlace Suites by Marriott San Diego Downtown | $170+tax | 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. GRC Seminars is not responsible for any inaccuracies in the same.
Register Online

Register Online

$1,699

Seminar One Registration

March 5-6, 2020, San Diego, CA
(Registrations till January 26, 2020 - $1699)
(Registrations after January 26, 2020 - $1999)

Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965


Download Registration Form

Yes, I want to attend "A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303
USA

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 @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of 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 $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future GRC Seminars 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 GRC Seminars cancels the seminar, GRC Seminars 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 before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of San Diego, CA

San Diego Cabrillo National Monument
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.

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 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
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 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.

Balboa Park
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.