ComplianceOnline

Register

Toll Free: +1-888-717-2436

CART 0

Your Shopping Cart

Contains 0 items
Total: $0.00
View Shopping Cart
Cart Image



Statistical Techniques for Medical Device Manufacturers

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

Course Description:

The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." Some manufacturers are not clear about what this means, while others employ statistical techniques but remain nervous about this means.

Similarly, sampling plans must be valid, documented, adequate, and reviewed based on changes.

In addition, statistical methodology, as part of CA & PA, is required to identity recurring quality problems based on data system analysis. A similar requirement applies to servicing analysis.

In addition, the requirement for process validation with a "high degree of assurance" is a requirement for process capability and product characteristics, i.e., a statistical technique.

These four areas often create a patchwork of techniques without a coherent approach. This seminar will help you resolve the problem.

The seminar starts with an understanding of the regulations through a variety of sources. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT) and then turns to Warning Letters to help understand the issues.



Learning Objective:

  • Learn the sections of FDA QSR that require statistical techniques.
  • Understand how to apply the FDA tools to develop a clear understanding of the requirements.
    • Regulation
    • Preamble
    • Small Entity Compliance Guide
    • QSIT
    • Warning Letters
  • Understand the set of statistical techniques in ISO/TR 10017
  • Learn how to implement and apply the ISO/TR 10017 statistical techniques.

The FDA regulations don’t provide the available techniques or their application. This is the role of ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000. While this guidance applies to ISO 9001, both FDA QSR and ISO 13485 are ISO 9001 successors.

The guidance document provides a list of statistical techniques and explains how each applies to the particular ISO 9001 clauses. Mapping these applications to FDA QSR is straightforward and provides a robust approach to help a manufacturer identify and implement the best approach.

As an added bonus, the seminar links the statistical techniques the ASQ Body of Knowledge for the Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Six Green Belt (CSSGB).



Who will Benefit:

All medical device manufacturers that apply FDA QSR or ISO 13485:2003:

  • 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




Course Outline:

Day One (8.00AM – 4.00PM) Day Two (8.00AM – 3.30PM)

  • Statistical Techniques in FDA QSR
  • Tools to help understand the regulations
    • QSR Sections
    • Preamble
    • Small Entity Compliance Guide
    • QSIT
    • Warning Letters
  • ISO/TR 10017 and what it tells us
  • Working with the statistical techniques
    • descriptive statistics
    • hypothesis testing
    • measurement analysis


  • Working with the statistical techniques (continued)
    • time series analysis
    • statistical process control
    • process capability analysis
    • regression analysis
    • reliability analysis
    • sampling
    • statistical tolerances




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.





Register Online


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com


Register by P.O. / Check


Yes, I want to attend "Statistical Techniques for Medical Device Manufacturers".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
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




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 @ 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.

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 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.

What past attendees say

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.

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

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






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

Located in the heart of Houston's Downtown Theater District, this 130,000 square foot entertainment megaplex is comprised of theaters, bars, lounges, and restaurants. Start the evening off with dinner at the legendary Hard Rock Café or the authentic Italian trattoria, Mingalone. Enjoy box office hits or catch the latest indie flick at the Angelika Film Center followed by drinks and dancing at ROCBAR, Houston's largest rock and roll nightclub.




The Galleria Houston, Texas's largest mall, is an upscale shopping mall centrally located just outside the 610 loop in Houston's Uptown District. The retail center is anchored by Macy's, Neiman Marcus, Nordstrom and Saks Fifth Avenue, and occupies such high-end tenants as Tiffany and Co., Dior, Louis Vuitton, and Yves Saint Laurent. The mall is also home to two separate Westin hotels.




The Lyndon B. Johnson Space Center, home of the NASA astronaut corps, is located in Southeast Houston. The center spans 1,620 acres and consists of 100 facilities. Tourists can experience a simulation of a zero-gravity environment in the Living in Space exhibit or encounter a virtual rocket launch complete with exhaust at the Blast Off Theater.




Sheltering over 4,500 animals and 900 species, The Houston Zoo is the 7th most visited zoo in the nation. Spend the day strolling through the facility's beautifully landscaped grounds or enjoy a more hands-on encounter by scheduling a guided tour. Tour experiences range from feeding a lion cub to shadowing a staff veterinarian for an entire day.




The Houston Museum District refers to the collection of museums, galleries, and cultural centers located within a 1.5 mile radius of Herman Park. The Museum of Fine Arts which also houses the Bayou Bend Collection and Gardens, boasts a collection of over 56,000 pieces. Just a few blocks away is the John P. McGovern Health Museum which is home to Houston's first and only 4D theater. Other area attractions include the Holocaust Museum, Houston Center for Photography, and the Lawndale Art Center.




Since the closing of Six Flags Astroworld, Kemah Boardwalk is now Houston's nearest and largest amusement/entertainment park. Largely occupied by hotels and restaurants, Kemah Boardwalk is an ideal place to entertain the entire family. Dining options include Landry's Seafood House, the Cadillac Bar, and Saltgrass Steakhouse. Attractions such as a Ferris wheel, train ride, and a carousel are all individually priced.




This family water park is located in North Houston (there's also a location in Galveston) and features several slides, a wild wave pool, and a lazy river. Younger guests can visit Crocodile Isle, a fully interactive children's play area complete with a pirate ship and kid-friendly slides.




One of Houston's most demographically diverse regions, Montrose has become the city's hub of vintage shopping, live music, and gay and lesbian activism. Restored mansions and bungalows, tree-lined boulevards, and an antique mall make this neighborhood a unique, pedestrian-friendly tourist spot.




Discover over 400 species of marine life and dine alongside a 150,000 gallon two-story tank at Downtown Aquarium. Witness White Tigers lounging about, pet a stingray, or go on an exhilarating train ride through the Shark Voyage. Wrap up the evening by feast on seafood entrees, steaks, and decadent desserts.




Located in North Houston, Old Town Spring is a community of shops, restaurants, and museums designed to resemble America during the early 1900's. Enjoy a nostalgic walk through the town's many Victorian-style antique shops, or catch a live music performance at the Jailhouse Saloon. Lodging options include two hotels and an RV resort.





Follow us :
We need below information to serve you better