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Statistical Techniques for Medical Device Manufacturers
Date
Dec 02, 2020 - 08:00 AM
- Dec 03, 08:00 AM
Link to Website
Organizer
Online Compliance Panel
Venue
Sheraton Fisherman's Wharf Hotel
Location
2500,
Mason St
San Francisco,
CA,
USA,
ZIP: 94133
Phone:
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.
Course DescriptionThe 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.
Learning Objectives
The workshop starts with an understanding of the regulations including QSR, ISO 13485:2003, and ISO 13485:2020. 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 13485:2020.
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 13485:2020 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 13485:2020
- 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 A - Statistical Techniques in the Regulations
- FDA QSR
- ISO 13485:2003
- ISO 13485:2020
- The Quality System Inspection Technique, QSIT
- The Medical Device Single Audit Program, MDSAP
- FDA Warning Letters
- The Problem and a Solution
- Using ISO/TR 10017:2003
- Using GHTF/SG3/N18:2010
- Data Types
- Measurement Scales
- Common Descriptive Statistics
- Graphical Methods
- Statistical Distributions
- Some Common Distributions
- 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
- Residuals
Part F1 - Attribute Sampling Plans
- Sampling Plan Concepts
- ANSI/ASQ Z1.4
- Single Sampling Plans
- Double and Multiple Sampling Plans
- c=0 Sampling Plans
- Normality Assumptions
- Acceptance Sampling Concepts
- ANSI/ASQ Z1.9 Methods
- Comparative Sample Size
- x-bar and R Charts
- x-bar and s Charts
- I and MR Charts
- OC and ARL Curves
- Calculating Control Lines
- Interpreting the Results
- p Charts
- np Charts
- u Charts
- c Charts
- OC and ARL Curves
- Calculating Control Lines
- Interpreting the Results
- 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.
Please contact Marilyn Turner: Phone: +1 929 900 1853 Email: marilyn.turner [a] nyeventslist.com for registrations
Event Categories
HEALTH AND MEDICINE CONFERENCES
, Healthcare
, Life Sciences, Biotechnology
Keywords: analysis, analyze, applications, arts, Clinical , design , development , Eating, graphical , identifyin