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A Comprehensive View of FDA Regulations for Medical Devices: 2-day In-person Seminar

By:
Dan O'Leary, President at Ombu Enterprises, LLC
Coming soon.. Please contact customer care for new schedule

Course Description:

The US medical device regulations include Part 820, the Quality System Regulation, but extend far beyond them. In order to understand the regulations, you need to look at more than just the quality management system. This course provides an overview and shows how the parts of the regulations fit together.

The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US. Device types 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 to market 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 course provides a comprehensive view of the regulatory requirements to help you understand the whole picture and provide effective implementation for your company.


Learning Objectives:

  • Learn the law, regulations, and policies that FDA applies for medical device.
  • Understand the concepts of pre-market approval 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 the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection.
  • Understand the FDA's inspection documentation tools including the FDA forms 482, 483, and 484.
  • Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered.
  • Learn the status of the Unique Device Identification (UDI) rule and considerations for implementation.


Who will Benefit:

All medical device manufacturers and companies involved in the medical device supply chain will benefit from this seminar.

  • 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
  • Medical/Marketing Personnel



Course Outline:

This 2-day course includes the following topics:

   
  • Legal and Regulatory Organization
    • Laws
    • Regulations
    • Guidance
    • Recognized Consensus Standards
    • FDA Organizational Structure
  • Medical Device Classification
    • Device classes
    • Device Panels
    • Device Regulations
    • Product Codes
  • Registration, Listing, and Clearance
    • Clearing devices, the 510(k) 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
    • Design Verification
    • Implementation

   
  • Production and Process Controls
    • Control of IM&TE
    • Equipment maintenance
    • Process validation
    • Software in production and the QMS
  • Sterilization Process Controls
    • Sterilization methods
    • Sterility Assurance Level (SAL)
    • Sterilization as a validated process
  • 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
  • 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
  • Unique Device Identification
    • Status of the regulation
    • Implementation issues




Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.




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Yes, I want to attend "A Comprehensive View of FDA Regulations for Medical Devices: 2-day In-person Seminar"

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




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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 @ editor@complianceonline.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 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 before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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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 use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Venue

Hotel:

Special Offer for the attendees of this seminar:

Call 1-877-734-2726 and give promo code #338671 to get 20% discount on Hotel room at Sheraton San Diego Hotel and Marina.

Hotel rooms are limited and based on availability.




View Larger Map


How to Reach

General Directions to the Hotel

From East
  • Take Interstate 8 West to I-5 South.
  • Take the Sassafrass/San Diego Airport Exit.
  • Turn right onto Laurel.
  • Turn right onto Harbor Drive.
  • Continue for 1.5 miles to Harbor Island.
From North
  • Take Interstate 5 South to the Sassafrass/San Diego Airport Exit.
  • Turn right onto Laurel.
  • Turn right onto Harbor Drive.
  • Continue for 1.5 miles to Harbor Island.
From San Diego International Airport
  • Follow the exit which becomes Harbor Island Drive.
  • Drive straight through the intersection to Harbor Island Drive.
  • The hotel is on the right-hand side.
From South
  • Take Interstate 5 North to the Hawthorne/San Diego Airport Exit.
  • Turn right onto Harbor Drive.
  • Continue for 1.5 miles to Harbor Island.

Airport

Brown Field Municipal Airport (SDM)
Travel Distance: Approximately 0.02 km/0.01 miles

San Diego International Airport (SAN)
Travel Distance: Approximately 1.61 km/1.0 miles

Montgomery Field (MYF)
Travel Distance: Approximately 11.27 km/7.0 miles

Railway

Santa Fe Depot
Travel Distance: Approximately 4.83 km/3.0 miles

Bus

Greyhound Bus Station
Travel Distance: Approximately 2.82 km/1.75 miles

Other

Downtown
Travel Distance: Approximately 4.83 km/3.0 miles





Testimonial

What past attendees say

With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.
- Quality Specialist, Rochester Medica

Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp

I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.

The MDD subject matter was well illustrated by Den by flow chart and graphics. Please keep offering this subject matter.
- Senior Quality Assurance Engineer, NDI Medical LLC

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
- Quality Engineering Manager, ConvaTec Inc.

I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.
- Director of Research and Development, Metrex Research,LLC

It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
- Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
- Director of Operations and Quality, NDI Medical LLC

I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.
- Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
- QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
- Quality Assurance, Beckman Coulter

Seminar was very informational with great resources. Topics were covered in depth.
- Quality Assurance, Encoll Corp

Session was very informative. Dan did a great job covering a lot of information, comprehensively, within such a short time of just 2 days. Can't wait to attend my next ComplianceOnline seminar.
- President, Medi-Stim, Inc

Seminar was very informative and helpful.
- Operations Director, Medi-Stim, Inc.



Media Partners

Sponsors



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

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.




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 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.




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 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.




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.




In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.





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