MedTech I.Q.

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