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

Sam Miller updated an event
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Webinar On "Assess Your Laboratory - Based on the FDA System Based Inspections" at Online

June 26, 2018 from 1pm to 2:30pm
Description :The Quality Control Laboratory plays an important part role in the production and release of a drug product regulated by the FDA. Inspectional observations of non-compliant laboratory operations are high on the list of most frequent regulatory observations. As the industry focuses more on the quality system and product and test method lifecycle, the operation of the laboratory unit becomes more visible. The laboratory should have active programs in which the laboratory is routinely…See More
Wednesday
Sam Miller posted an event
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Webinar On "Assess Your Laboratory - Based on the FDA System Based Inspections" at Online

June 6, 2018 from 1pm to 2:30pm
Description :The Quality Control Laboratory plays an important part role in the production and release of a drug product regulated by the FDA. Inspectional observations of non-compliant laboratory operations are high on the list of most frequent regulatory observations. As the industry focuses more on the quality system and product and test method lifecycle, the operation of the laboratory unit becomes more visible. The laboratory should have active programs in which the laboratory is routinely…See More
Jun 4
Sam Miller posted events
May 29
Sam Miller posted an event
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Webinar On "Mobile medical apps (is it a FDA regulated device) and cybersecurity" at Online

June 5, 2018 from 1pm to 2:30pm
Description :This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.Objective :What mobile apps are medical devicesWhat mobile apps will be…See More
May 22
Sam Miller posted an event
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Webinar On "What to Do When it's Not a Bell Curve" at Online

May 18, 2018 from 1pm to 2pm
Description :Statistical process control (SPC), process performance indices (Ppk), and acceptance sampling by variables (ANSI/ASQ Z1.9, or formerly MIL-STD 414) rely on the assumption that the process data follow the normal or bell curve distribution. This distribution is far more common in textbooks than in the real world. Generally accepted and off the shelf methods are however available for SPC and process performance analysis for non-normal distributions. While we are not aware of formal…See More
May 10
Sam Miller posted an event
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Webinar On "Cycle Time Analysis (CTA)" at Online

May 15, 2018 from 1pm to 2:15pm
Description :Companies can quickly assess their inventory and throughput status by walking around the incoming, in process and shipping inventory areas and looking for stacks of materials and inventory. Stacks of inventory need to be perceived as stacks of money – company money, employee pay, and investment money. Inventory must be reduced at all stages and achievement of smoothed processing flow established. Cycle time analysis is a simple tool to help all company players get on board with…See More
May 2
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Apr 26
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Apr 13
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Mar 26
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Mar 12
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Mar 6
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Feb 27
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Feb 20
Sam Miller posted an event
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Webinar On "CMS Guidelines Healthcare Sanitary Condition, Long Term Care 483.60(i)(1)(2 & HOSPITALS 483.28." at Online

February 23, 2018 from 1pm to 2:30pm
Description :This 90-minute webinar on Sanitary Conditions is a “Annual Refresher/Introduction to Sanitary Conditions within (Long Term Care Organizations) §483.60 Food and Nutrition Services, and (Hospital) §482.28 Food and Dietetic Services. May serve as a Management Team Review of Center of Medicaid and Medicare, CMS Guidelines & Investigative Protocol, Process.Objective :Sanitary Condition is a reference to “the standard Providers (Healthcare Organizations) must maintain to Participate…See More
Feb 13
Sam Miller posted an event
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Webinar On "GMPs for Active Pharmaceutical Ingredients" at Online

February 21, 2018 from 1pm to 2:30pm
Description :In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, and discuss how this is supplemented by contemporary guidance such as ICH Q10, the Pharmaceutical Quality System, ICH Q8, Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q11, Development and Manufacture of Drug Substances. The…See More
Feb 12
Sam Miller posted events
Feb 7

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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