Course " Statistical Techniques for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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". When device manufacturers analyze CA & PA information, they must also use "appropriate statistical methodology". In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes.
Some manufacturers are not clear about all of this. Others are nervous about creating a sufficient approach to make good decisions and satisfy the regulations. The result may be a patchwork of techniques without a coherent methodology. This workshop helps resolve the problem.
The workshop starts with an understanding of the regulations including QSR, ISO 13485:2003, and ISO 13485:2016. It also includes the methods regulators use to check compliance including the Quality System Inspection Technique (QSIT), FDA Warning Letters, and the Medical Device Single Audit Program (MDSAP).
The FDA regulations don't provide a catalog of available techniques or their application. This is the role of ISO/TR 10017:2003Guidance on statistical techniques for ISO 9001:2000. While this guidance was written for ISO 9001:2000, it is easily applicable to FDA QSR, ISO 13485:2003, and ISO 13485:2016.
The guidance document provides a list of statistical techniques and explains how each applies to particular ISO 9001:2003 clauses. Mapping these applications to FDA QSR, ISO 13485:2003, and ISO 13485:2016 is straightforward and provides a robust approach to help a manufacturer identify the appropriate methods.
The workshop explains the many of the techniques, shows how they apply using medical device examples, and includes exercises for participants to solidify understanding.
Why Should you Attend
Statistical techniques are powerful methods for medical device manufactures since they can help improve efficiency and effectiveness. Many techniques apply in a variety of situations. This workshop explains how to evaluate the situation, determine the correct technique and apply it. In addition, since there are regulatory requirements, the workshop includes the necessary documentation to satisfy audits and inspections.
Who will Benefit
- All medical device manufacturers that apply FDA QSR, ISO 13485:2003 or ISO 13485:2016
- 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
- CA&PA team members
Day One (8:00 a.m. - 8:30 a.m.: Registration Process)
Part A - Statistical Techniques in the Regulations
Part B - Identifying Statistical Techniques
- FDA QSR
- ISO 13485:2003
- ISO 13485:2016
- The Quality System Inspection Technique, QSIT
- The Medical Device Single Audit Program, MDSAP
- FDA Warning Letters
Part C - Descriptive Statistics
- The Problem and a Solution
- Using ISO/TR 10017:2003
- Using GHTF/SG3/N18:2010
Part D - Hypothesis Tests
- Data Types
- Measurement Scales
- Common Descriptive Statistics
- Graphical Methods
- Statistical Distributions
- Some Common Distributions
Part E - Regression Analysis
- The Concepts
- Comparing a Mean to a Standard
- Comparing Two Means
- Paired t-Test
- Other Applications
- The Concepts
- Linear and Non-linear Methods
- Using Excel
Part F1 - Attribute Sampling Plans
Part F2 - Variables Sampling Using Z1.9
- Sampling Plan Concepts
- ANSI/ASQ Z1.4
- Single Sampling Plans
- Double and Multiple Sampling Plans
- c=0 Sampling Plans
Part G1 - SPC Variables Charts
- Normality Assumptions
- Acceptance Sampling Concepts
- ANSI/ASQ Z1.9 Methods
- Comparative Sample Size
Part G2 - SPC Attributes Charts
- x-bar and R Charts
- x-bar and s Charts
- I and MR Charts
- OC and ARL Curves
- Calculating Control Lines
- Interpreting the Results
Part H - Process Capability Analysis
- p Charts
- np Charts
- u Charts
- c Charts
- OC and ARL Curves
- Calculating Control Lines
- Interpreting the Results
Part I - Measurement System Analysis (MSA)
- Cp and Pp
- Cpk and Ppk
- Interpreting the Results
- Measurement Analysis
- The Components of Variability
- Applications to Metrology
Daniel O'Leary - President, Ombu Enterprises, LLC
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan 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; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Register yourself for this brainstorming session Now . You can do single registration or group or register via P.O/Check or Wire.
Register by P.O. / Check / Wire Transfer
Excited to join the workshop on "Statistical Techniques for Medical Device Manufacturers" then register for the same by P.O. / Check / Wire Transfer. Call us Toll Free at (510)-857-5896 for any registration related assistance.
If you are Paying by Check:
Checks should be payable to Holkoi LLC and mailed to:
38780 Tyson Lane Suite 210 Fremont
California 94536, USA
If you wish to pay by wire transfer. Call us toll free on 510-857-5896
In case you find difficulty in registering, availing the discount or need further information regarding the workshop, please feel free to contact our customer support team at (510)-857-5896
or send an email to email@example.com
. We will help you.
Terms & Conditions to Register for the Workshop
Your registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for the workshop call us at (510)-857-5896 or email us at firstname.lastname@example.org
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to HOLKOI LLC. (our parent company)
If you are paying by check, the check should be payable to HOLKOI LLC and mailed to: 38780 Tyson Lane Suite 210 Fremont California 94536
The registration fee includes: The workshop; all related course materials; tea/coffee and lunch on both the days
Cancellations and Substitutions
For online registration, use your American Express, Visa or MasterCard.
In case you find difficulty in registering, call us at (510)-857-5896 or sent an email to email@example.com.
We will help you to register hassle-free.
Any cancellation request received at least 10 calendar days prior to the start date of the event will receive a refund with a $200 administration fee deduction. No cancellations will be accepted - nor refunds issued - within 10 calendar days from the start date of the event.
On request (before the commencement of the workshop) a credit for the amount paid minus administration fees ($200) will be transferred to any future Online Compliance Panel event and a credit note will be issued. Substitutions may be made at any time.
Onsite registrations are also possible. However we accept only credit card payments and check payments. Conference material will be issued on the spot depending on the availability. In case it is not available we will send the material by post after the conference is over. In the event, Online Compliance Panel cancels the workshop; the company 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.
Conference Photograph / Video
By registering and attending Online Compliance Panel workshop, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Online Compliance Panel using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Online Compliance Panel from any kind of claims arising out of copyright or privacy violations.
Documents to Carry
Online Compliance Panel will issue an electronic event pass to each registered candidate once the registration is confirmed. Please bring the pass to the venue of the event.
San Francisco, CA
Sheraton Fisherman's Wharf Hotel
2500 Mason Street, San Francisco,
Local Attractions :
California Academy of Sciences
California Academy of Sciences is a unique attraction, which was reopened in 2008. Known as "the greenest museum on the planet" California Academy of Sciences is the world's only aquarium-planetarium-rainforest-living museum. Take a walk over to "Earthquake: Life on a Dynamic Planet" where you can walk through a model of the earth and brave the infamous Shake House.
Ride the Cable Cars
Cable cars are the City's only moving historic landmark and it is still used by the locals for transport from one part of the city to the other. Currently the cable cars are run on three lines: the Powell-Hyde Line, the Powell-Mason Line and the California Street Line. Riding the cable cars is one of the best and popular things to do in San Francisco.
One of most infamous prisons of America, Alcatraz penitentiary is located on Alcatraz Island in San Francisco Bay. This federal penitentiary operated from 1934 to 1963. Some of the famous inmates include Al Capone, George "Machine Gun" Kelly, and Robert Stroud "The Birdman of Alcatraz." Take the Cellhouse Audio Tour, which brings Alcatraz to life with actual voices of the correctional officers and inmates who lived on the island for a more enhanced experience.
Golden Gate Bridge
The Golden Gate Bridge, which was first opened in 1937, is perhaps San Francisco's top recognized landmark. Because of its architectural excellence, American Society of Civil Engineers named this bridge as one of the Wonders of the Modern World. Over 9 million visitors cross the 1.7-mile long bridge annually. Ensure to get some remarkable photographs of the Golden Gate Bridge from both sides of the channel.
Golden Gate Park
Golden Gate Park is the third most visited parks in the United States. This great park is home to various gardens, lakes, playgrounds, trails, and more. You can rent a boat, stroll along the walking and biking paths, or find one of the many ideal locations for a quiet picnic or nap. Golden Gate Park also houses the de Young Museum and California Academy of Sciences, which are San Francisco's top rated attractions.
This is the best place to have some lip smacking seafood. Being the historic center of the city's fishing industry; Fisherman's Wharf is a working neighborhood and commercial area. You can spend a whole day browsing and tasting the delicacies at the restaurants and shops here. Tourist spots like Alcatraz Cruises, Blue & Gold Fleet cruises, and the Aquarium of the Bay are located near the Fisherman's Wharf.
With more than 600 exhibits, exploratorium could be enjoyed by visitors of all ages. This iconic San Francisco discovery destination had a brand-new home at Pier 15 on San Francisco's historic Embarcadero waterfront. There are six main galleries in the Exploratorium, each focusing on a different area of exploration and are aptly named Human Phenomena, Living Systems, Seeing and Listening, Tinkering, Outdoor Exhibits, and Observing Landscapes. Watch for the 27-foot-tall Aeolian Harp, which gets strummed by the wind.
San Francisco's Chinatown
San Francisco's Chinatown established in 1840s is the oldest and most reputed Chinatowns of all Chinatowns outside Asia. The tourist section of Chinatown is mainly along Grant Avenue, from Bush to Broadway. Many of the Chinese who settled here were merchants or immigrant workers, working on either the transcontinental railroad or as mine workers during the Gold Rush