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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 events
Nov 27
Sam Miller posted an event
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Webinar On "Medical Device cybersecurity following latest FDA Guidance" at Online

November 28, 2018 from 1pm to 2pm
Description :The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant to the FDA requirements.Areas Covered in the Session…See More
Nov 15
Sam Miller posted an event
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Webinar On "Chipping away at constraints – Practical tips to improve your manufacturing operations" at Online

November 15, 2018 from 1pm to 2:30pm
Description :Some of us feel that we have to hire a guru in order to apply the Theory of Constraints.Here are some practical things all of us can do to "chip away" at a constraint - and yield major improvements to your operation.Areas Covered in the Session :Identifying a constraint in a process by its symptoms.How to "chip away" at the constraint. Some steps at the constraint can be done by upstream or downstream operations.How to increase the overall throughput of your production line.Who…See More
Nov 8
Sam Miller posted an event
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Webinar On "Use Shingo Process Maps to Drive Improvement" at Online

November 1, 2018 from 1pm to 2pm
Description :Shingo process maps, while designed originally for specific improvement processes, are usable as data-driven living process improvement tools that also document the process to support ISO 9001:2015. They can, in the role of process flowcharts, use production data to expose quickly wastes of time, material, and even energy to initiate corrective and preventive action to remove the wastesWho Will Benefit:Manufacturing and quality engineers and technicians, especially those with…See More
Oct 30
Sam Miller posted an event
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Webinar On "Medical Waste Management: Compliance & Disposal" at Online

October 30, 2018 from 1pm to 2pm
Description :Identification of medical waste and applicable categories, how to properly handle/store different types of waste on-site, lifecycle to include transportation and recycling/disposal.Objective :Provide audience with thorough knowledge to maintain regulatory compliance in all areas of medical waste management and understand lifecycle.Areas Covered in the Session :Identification of medical waste and applicable categorieshow to properly handle/store different types of waste…See More
Oct 22
Sam Miller posted events
Oct 17
Sam Miller posted an event
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Webinar On "Through the Eyes of an Auditor" at Online

October 16, 2018 from 1pm to 2:30pm
Description :Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for. Anyone in a medical device setting must be prepared for an audit at any and all times. This webinar…See More
Oct 10
Sam Miller posted an event
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Webinar On "Sequential Sampling to Reduce Inspection Costs" at Online

October 4, 2018 from 1pm to 2pm
Description :ANSI/ASQ Z1.4 (formerly MIL-STD 105) is a generally accepted sampling standard for pass/fail data. This webinar will show that, while the standard's double and multiple sampling plans reduce the amount of inspection, minimal inspection can be achieved with sequential sampling; a process in which the consecutive sample sizes are 1. Attendees will learn how to convert an ANSI/ASQ Z1.4 plan into a sequential sampling plan that provides comparable protection against poor quality, and…See More
Oct 1
Sam Miller posted events
Sep 3
Sam Miller posted an event

Effective Design of Experiments (DOE) Strategies at Online

August 30, 2018 from 1pm to 2:30pm
Description :The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum. NOTE: This webinar focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.Why ?Effective DOE strategiesAvoiding pitfalls when performing DOEsHow to capture the essence of a processUsing the…See More
Aug 20
Sam Miller posted an event
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Webinar On "Environmental Contamination of Ready-to-Eat (RTE) Foods and the Role of Environment" at Online

August 22, 2018 from 1pm to 2:30pm
Description :One of the three most critical food safety issues facing the food industry today is environmental contamination of ready-to-eat foods (RTEs). Ready-to-eat foods have no kill step applied between the sale of the product and consumption by consumers. Demand for such product is drastically increasing as consumers look for increasing levels of convenience. Over the past several years, FDA recall investigations have repeatedly shown that most farms are impacted by a myriad of…See More
Aug 2
Sam Miller updated an event
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Webinar On "Grok the Muda : We Must Recognize Waste To Remove It" at Online

August 8, 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
Jul 30
Sam Miller posted an event
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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
Jul 23
Sam Miller posted an event
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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
Jul 20
Sam Miller updated an event
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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

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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At 5:35am on November 4, 2018, Marlis Ahmed said…

Good Day,
How is everything with you, I picked interest on you after going through your short profile and deemed it necessary to write you immediately. I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site.Could you please get back to me on:( mrsstellakhalil588@gmail.com ) for the full details.

Have a nice day
Thanks God bless.
Stella.

 
 
 

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