MedTech I.Q.

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Sam Miller
  • Male
  • Bethesda, Maryland
  • United States Minor Outlying Islands
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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
Sam Miller posted events
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
Sam Miller posted an event
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Webinar On "Corrective and Preventive Action utilizing the principles of Lean Documents and Lean Configuration" at Online

February 7, 2018 from 1pm to 2:30pm
Description :The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same…See More
Jan 31
Sam Miller posted an event
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Webinar On "SOX – Demystifying the Documentation Process" at Online

February 6, 2018 from 1pm to 2pm
Description :Many people feel overwhelmed when faced with the daunting task of documenting their company’s Sarbanes-Oxley controls. This presentation will help you to confidently deliver SOX documentation which auditors and executives are pleased to sign. The SOX documentation process does not have to be complicated. This presentation will show you how simple it can be.Objective :Documentation is simply writing down what it is that your company does to prove that effective controls have…See More
Jan 29
Sam Miller posted an event

Webinar On "Making of financial statements: Accounting 101 simplified" at Online

January 30, 2018 from 1pm to 2:30pm
Description :All business produce financial transactions.  These transactions are transformed into three financial statements that indicate the financial results produced from these transactions.  Results are expressed in required statements: Balance Sheet, Income Statement, and Cash Flow Statement. I guarantee you will be amazed and impressed at how simple it is to understand the process of transforming transactions into statements!Objective :Review of business/financial transactionsProcess…See More
Jan 22
Sam Miller posted an event
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Webinar On "Method Validation and Test Method Lifecycle. The application of Lifecycle concepts to test methods" at Online

January 24, 2018 from 1pm to 2:30pm
Description :Analytical Method Validation should be approached with a clear understanding of the intended use of the method in mind and an understanding of the application of the intended use through the lifecycle of the method.  The approach to Analytical Method Validation should be consistent with the concepts discussed in a recent USP stimulus paper and articles published in the USP since the concept paper.Objective :This webinar will help personnel in the Analytical Method Development…See More
Jan 20
Sam Miller posted events
Jan 11
Sam Miller posted an event
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Webinar On "Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration" at Online

January 9, 2018 from 1pm to 2:30pm
Description :All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Utilizing suppliers as an extension of an organization´s design and manufacturing capabilities presents unique challenges.Background :Many companies have outsourced both their design and manufacturing to specialized suppliers.  As new medical device technologies push the boundaries of…See More
Jan 4
Sam Miller posted an event
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Medical Device MDR following new FDA Guidance at Online

January 11, 2018 from 1pm to 2:30pm
Description :   This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include reporting requirements, record keeping requirements, report timing, clarification of the term “becoming aware” and clarification of reporting using form 3500A.Why :   FDA Medical Device Reporting (MDR) regulations require firms who have received complaints of device malfunctions, serious injuries or deaths…See More
Dec 30, 2017

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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