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Sam Miller
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  • Bethesda, Maryland
  • United States Minor Outlying Islands
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Latest Activity

Sam Miller posted an event

Webinar On "Method Validation and Test Method Lifecycle. The application of Lifecycle concepts to test methods" at Online

January 24, 2018 from 1pm to 2:30pm
Description :Analytical Method Validation should be approached with a clear understanding of the intended use of the method in mind and an understanding of the application of the intended use through the lifecycle of the method.  The approach to Analytical Method Validation should be consistent with the concepts discussed in a recent USP stimulus paper and articles published in the USP since the concept paper.Objective :This webinar will help personnel in the Analytical Method Development…See More
17 hours ago
Sam Miller posted events
Jan 11
Sam Miller posted an event

Webinar On "Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration" at Online

January 9, 2018 from 1pm to 2:30pm
Description :All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Utilizing suppliers as an extension of an organization´s design and manufacturing capabilities presents unique challenges.Background :Many companies have outsourced both their design and manufacturing to specialized suppliers.  As new medical device technologies push the boundaries of…See More
Jan 4
Sam Miller posted an event

Medical Device MDR following new FDA Guidance at Online

January 11, 2018 from 1pm to 2:30pm
Description :   This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include reporting requirements, record keeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using form 3500A.Why :   FDA Medical Device Reporting (MDR) regulations require firms who have received complaints of device malfunctions, serious injuries or deaths…See More
Dec 30, 2017
Sam Miller posted an event

Webinar On "Health Care Contracting Toolkit: Best Practices & Three Key Tenets of Defensibility" at Online

December 15, 2017 from 1pm to 2pm
Description :This webinar will include a “Contracting Toolkit” of best practices that health care organizations can follow to avoid compliance traps related to the technical requirements for payments to physicians and the Three Key Tenets of Defensibility: fair market value, commercial reasonableness, and not taking into account volume or value of referrals. The session will also recap trends in government and whistleblower enforcement. Background of the TopicAny time a health care organization…See More
Dec 9, 2017
Sam Miller posted an event

Webinar On "Laboratory Instrument Qualification" at Online

December 12, 2017 from 1pm to 2:30pm
Description :Regulations, good science and good business require that pharmaceutical Quality Control and Method Development Laboratories use instruments and equipment that are suitable for their intended uses. Effective instrument and equipment qualifications provide assurance that these devices are appropriate for their intended use in development and Quality Control laboratories.Why Should You Attend ?Laboratories have conducted some level of equipment qualification since the invention of…See More
Dec 7, 2017
Sam Miller posted an event

Webinar On "Measurement Systems Analysis" at Online

December 7, 2017 from 1pm to 2pm
Description :Calibration of gages and instruments is a familiar activity whose purpose is to determine whether the gages in question return, on average, the same dimensions as the standards against which they are calibrated. This is required by ISO 9001. Calibration does not, however, ensure or even measure precision; the consistency with which the gages return the dimension in question. This is the purpose of measurement systems analysis (MSA), or gage reproducibility and repeatability…See More
Nov 29, 2017
Sam Miller posted an event

Webinar On "Compensation-Focused Compliance: Is Your Healthcare Organization Ready for Shifts in Stark Law Enforcement?" at Online

November 16, 2017 from 1pm to 2pm
Description :Compliance issues related to physician compensation have been a key area of discussion in health care for a number of years. However, because of the substantial awards and settlements in recent Stark Law enforcement actions, compensation-focused compliance has become more than just a compliance issue: it is an enterprise risk management issue. This webinar will discuss strategies for ensuring physician compensation plans and compensation-focused governance processes support…See More
Nov 14, 2017
Sam Miller posted an event

Webinar On "Lose the Luddites" at Online

November 8, 2017 from 1pm to 2pm
Description :Luddism, or resistance to efficiency improvements, as a frequent stumbling block for lean manufacturing initiatives. Luddism, work-to-rule, and soldiering (marking time) all are similar, and all result directly from workers' fears that automation or other efficiency improvements will result in layoffs. This webinar will show what management needs to do to eliminate Luddism and gain the worker buy-in and engagement that can make rather than break lean manufacturing and Lean Six…See More
Oct 27, 2017
Sam Miller updated an event

Webinar On "Structuring and Auditing Physician Employment Agreements: Key Stark Law Considerations" at Online

October 13, 2017 from 1pm to 2pm
Description :As health care organizations and physicians develop employment arrangements, they must manage their compliance and enterprise risk by ensuring the employment is defensible under the Stark Law. Prior to moving forward with any employment arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event…See More
Oct 6, 2017
Sam Miller posted events
Oct 4, 2017
Sam Miller updated an event

Webinar On "Introduction to Design of Experiments" at Online

September 27, 2017 from 1pm to 2pm
Description :Design of Experiments (DOE) is an important technique for root cause analysis (RCA) and process improvement. As an example, when potential trouble sources are identified from a cause and effect diagram, DOE can be used to determine which of the factors are likely to be important. DOE can also develop quantitative models of the nature y=f(x) (y is a function of x) where y is often a critical to quality characteristic. Objective of the webinar :Attendees will learn the fundamentals…See More
Sep 18, 2017
Sam Miller updated an event

Webinar On "Deviations and Investigations FDA Observations and How To Avoid Them" at Online

September 21, 2017 from 1pm to 2:30pm
Description :The GMPs require that the pharmaceutical firm complete and report an investigation of any product or process deviation or discrepancy and the FDA reviews investigations in depth in most site inspections. As a result, inadequate investigation is high on the list of FDA observations. Pharmaceutical firms either do not understand the expectation for, and value of, a thorough, timely investigation, or are not willing to commit the resources to appropriate investigations. In this…See More
Sep 18, 2017
Sam Miller posted events
Sep 7, 2017
Sam Miller posted an event

Webinar On "Moving from GMPs to the Pharmaceutical Quality System" at Online

August 17, 2017 from 1pm to 2:30pm
Description :Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System. This is supported by an FDA Guidance Document: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System. It is clear from FDA Form 483, Report of Observations given to pharmaceutical manufacturers and Warning Letters that the FDA is interpreting the GMPs (21CFR211) consistent with concepts found in ICH Q10;…See More
Aug 10, 2017
Sam Miller posted an event

Webinar On "The Real Cost of The Food Code- Healthcare Settings, The Food Code serves as a guide to close the Gap, Leveraging Risk and Service" at Online

July 31, 2017 from 1pm to 2:30pm
Description :Leveraging Information to Navigate Food Safety and Consumer Concerns  Food safety has become a major topic that must be considered by both institutions and producers within the food supply chain to calculate the risk and reduce the likelihood of not just outbreaks, but closing the gap on consumer preferences, allergies, diet restrictions. Under 483.60 Food & Nutrition Services, §482.28 (Hospital) Food and Dietetic Services, food procurement, production, processing, sales and…See More
Jul 25, 2017

Profile Information

Area of Expertise or Interest?
Medical, Pharmaceutical, Healthcare, Food & etc..
Type of Affiliation?
Years of Experience in MedTech Field

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