overview

Developing a Quality Management System (QMS) as a prerequisite for getting accredited is relatively easy. Maintaining the quality management software to retain your accreditation status is the real challenge and a measure of the robustness of your System.

why should you attend

Many laboratories struggle with developing and implementing a functional quality management software that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits. Why do you want to become accredited? Where do you start? For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? Getting there is relatively easy. Staying there is the hard part.

Areas Covered

  • Defining a Quality Management System (QMS)
  • Management Components of a QMS
  • Technical Components of a QMS
  • Method Selection, Validation and Verification
  • What is competency management?
  • Ensuring analyst competency

Learning Objectives

  • Why do you want to become accredited?
  • Where do you start?
  • For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Click to View the Pricing Plan

Seminar Fee includes:

Lunch Beverages Seminar Material USB with seminar presentation Presentation Printouts Participation Certificate Take away kit with $100 Gift voucher

CREDITS

Agenda

Day One (8:00 a.m. - 8:30 a.m.: Registration Process)

Part A - Statistical Techniques in the Regulations

  • 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 B - Identifying Statistical Techniques

  • The Problem and a Solution
  • Using ISO/TR 10017:2003
  • Using GHTF/SG3/N18:2010

Part C - Descriptive Statistics

  • Data Types
  • Measurement Scales
  • Common Descriptive Statistics
  • Graphical Methods
  • Statistical Distributions
  • Some Common Distributions

Part D - Hypothesis Tests

  • The Concepts
  • Comparing a Mean to a Standard
  • Comparing Two Means
  • Paired t-Test
  • Other Applications

Part E - Regression Analysis

  • The Concepts
  • Linear and Non-linear Methods
  • Using Excel
  • Residuals

Day Two

Part F1 - Attribute Sampling Plans

  • Sampling Plan Concepts
  • ANSI/ASQ Z1.4
  • Single Sampling Plans
  • Double and Multiple Sampling Plans
  • c=0 Sampling Plans

Part F2 - Variables Sampling Using Z1.9

  • Normality Assumptions
  • Acceptance Sampling Concepts
  • ANSI/ASQ Z1.9 Methods
  • Comparative Sample Size

Part G1 - SPC Variables 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 G2 - SPC Attributes Charts

  • p Charts
  • np Charts
  • u Charts
  • c Charts
  • OC and ARL Curves
  • Calculating Control Lines
  • Interpreting the Results

Part H - Process Capability Analysis

  • Cp and Pp
  • Cpk and Ppk
  • Interpreting the Results
  • Part I - Measurement System Analysis (MSA)
  • Measurement Analysis
  • The Components of Variability
  • Applications to Metrology

SPEAKER

Ed Krow, SPHR, CCP, SHRM-SCP, CHCM, of TurboExecs partners with results-oriented, small and medium businesses that are struggling with chaos, such as out-of-control growth, sudden terrifying decline in revenues or profits, or people problems that are having a negative impact on the business.

He helps them put in place training, compliance and compensation systems so they avoid legal issues while offering both development opportunities and competitive packages that incentivize performance in alignment with their business goals. Ed’s clients often refer to him as their “Safety Net,” because he keeps them from falling into HR traps and eliminates HR headaches.

When he’s not working with clients, Ed can be found teaching at Millersville University or speaking at Human Resources conferences, seminars, and professional development sessions. In his free time, Ed enjoys family time, travel, golf, the outdoors and Notre Dame and Baltimore Ravens football.

Location



Contact info


Location:

San Francisco, CA

Venue/Hotel:

Local Attractions of San Francisco, CA

California Academy of Sciences
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
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.

Sponsors & Exhibitors

5 Reasons to Sponsor a Compliance Global Event.

  • Put your business in the spotlight.
  • Engage and network with the attendees.
  • Lead generation and build new contacts.
  • Build brand awareness and get your brand noticed.
  • Market your business inexpensively.

You will be getting direct access and face time with hundreds of attendees who are your target market. By leveraging the event to your advantage, there will be no limit on your potential ROI.

We are happy to help you with flexible exhibitor, sponsorship and media partnership options. Advantages of becoming a Sponsor/Exhibitor;

  • Logo on website, marketing email, branding materials & the registration booth.
  • Exhibitor Space and free event pass.
  • Speaking opportunity in the event.
  • Presence in our Social media campaigns

For more details on our exhibitor and sponsorship options, please contact our Events Manager; Michael Smith @ michael@ complianceglobal.us or call us on 516-900-5505.

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Looking to host a webinar at your organization?

Contact us for Customized solutions
+1.516.900.5506

michael@complianceglobal.us

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TESTIMONIALS