MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Sam Miller
  • Male
  • Bethesda, Maryland
  • United States Minor Outlying Islands
Share on Facebook Share on Facebook Share
  • Blog Posts
  • Upcoming Events (3)
  • MedTechIQ Groups
  • MedTech-IQ ... At a Glance
  • Photo Albums
  • MedTechIQ VideoLibrary

Gifts Received

Gift

Sam Miller has not received any gifts yet

Give a Gift

 

Sam Miller's Page

Latest Activity

Sam Miller posted an event
Thumbnail

Webinar On "GMPs in the 21st Century - How the interpretation and enforcement of the GMPs is evolving" at Online

August 16, 2018 from 1pm to 2:30pm
Description :The existing GMPs were finalized in 1979 and the industry has changed considerably since that time. In 2001 the FDA announced to the pharmaceutical industry that it would regulate the industry based on good science and risk. Since that time the Agency has partnered with ICH in the release of ICH Q8, Pharmaceutical Development, ICH Q9, Risk Management and ICH Q10, The Pharmaceutical Quality System. FDA has also issued guidances on Process Validation, Quality Metrics and Data…See More
5 hours ago
Sam Miller posted an event
Thumbnail

Webinar On "Grok the Muda : We Must Recognize Waste To Remove It" at Online

August 7, 2018 from 1pm to 2pm
Description :"Grok," from Robert A. Heinlein's Stranger in a Strange Land, means "to understand so thoroughly that the observer becomes a part of the observed. "The Merriam-Webster dictionary defines it as follows: "to understand profoundly and intuitively." Taiichi Ohno applied the same principle to all forms of waste. "To implement the Toyota production system in your own business, there must be a total understanding of waste." This means we must thoroughly grok the muda.ObjectiveAttendees…See More
Friday
Sam Miller updated an event
Thumbnail

Webinar On "Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process" at Online

July 26, 2018 from 1pm to 2:30pm
Description :ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle. Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management, are closely integrated with ICH Q10. In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and…See More
Jul 14
Sam Miller posted events
Jun 27
Sam Miller updated an event
Thumbnail

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
Jun 13
Sam Miller posted an event
Thumbnail

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
Thumbnail

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
Thumbnail

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
Thumbnail

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
Sam Miller posted events
Apr 26
Sam Miller posted events
Apr 13
Sam Miller posted events
Mar 26
Sam Miller posted events
Mar 12
Sam Miller posted events
Mar 6
Sam Miller posted events
Feb 27

Profile Information

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

Comment Wall

You need to be a member of MedTech I.Q. to add comments!

Join MedTech I.Q.

  • No comments yet!
 
 
 

© 2018   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service