MedTech I.Q.

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

Sam Miller posted an event
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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
Tuesday
Sam Miller posted an event
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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
Sam Miller updated an event
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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
Sam Miller posted events
Oct 4
Sam Miller updated an event
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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
Sam Miller updated an event
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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
Sam Miller posted events
Sep 7
Sam Miller posted an event
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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
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
Sam Miller posted an event

Verification of Compendial methods: Discussion of the verification of compendial methods when introduced in a laboratory. This is patterned after USP <1226> and the FDA Stimulus Article at Online

July 13, 2017 from 1pm to 2:30pm
Description :According to the US GMPS; "The suitability of all testing methods shall be verified under actual conditions of use". This is supported by the USP, which states; "Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use." A modified definition of the accepted definition of test method validation "Documented evidence that…See More
Jul 5
Sam Miller is now a member of MedTech I.Q.
Jul 4

Profile Information

Area of Expertise or Interest?
Medical, Pharmaceutical, Healthcare, Food & etc..
Type of Affiliation?
Industry
Years of Experience in MedTech Field
1

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