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List of management educations - cme : 11 results

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How to Develop the Risk Management File - 2017

Ref: 25882 Wednesday October 18th, 2017 - Online

Overview: The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer. ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

483 Covers a Broad Gradation of Problems

Ref: 25883 Wednesday October 25th, 2017 - Online

Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

NIST Cybersecurity Framework For Computer Systems Validation

Ref: 25884 Wednesday October 25th, 2017 - Online

Overview:   Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.  ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

Guidance on Software and Device Changes and the 510(k)

Ref: 25885 Monday October 30th, 2017 - Online

Overview:   The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.   Why should you Attend: Anyone who is involved in software and device design, ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

Calculating, and Using Statistical Power 2017

Ref: 26031 Monday November 06th, 2017 - Online

Overview: This webinar explains the basics, by using a t-test as an example. One of the very many possible formulas is then demonstrated, as well as 2 different software programs and their "Power Curves".    Why should you Attend: Whenever a test of statistical significance is ...

Education: Management, Public Health, Pharmacy

7 Megatrends that Will Transform the Global Marketplace

Ref: 26032 Tuesday November 07th, 2017 - Online

Overview:   The trends will impact virtually every industry that is dependent on supply chains. There is a convergence of supply chain trends that will dramatically change the global marketplace.   Why should you Attend: Understanding of the supply chain trends that will ...

Education: Medicine, Management, Public Health, Pharmacy

Medical Device Hazard Analysis Following ISO 14971 - 2017

Ref: 26033 Wednesday November 08th, 2017 - Online

Overview:   The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.   Why should you Attend:  FDA expects that as part of ...

Education: Pharmacy, Medicine, Management, Public Health

Agile Meets Software Standards, and We all Win

Ref: 26034 Tuesday November 14th, 2017 - Online

Overview: Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators.   Why should you Attend:  Perhaps you're a development manager, hoping to improve both productivity and ...

Education: Pharmacy, Medicine, Public Health, Management

Latest Regulations for Tobacco Industry Effective 8-2016

Ref: 26035 Tuesday November 14th, 2017 - Online

Overview: The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.   Why should you Attend: How to Build a Compliance Strategy Minimizing Cost while ...

Education: Medicine, Pharmacy, Management

It is not enough to Simply be a Project Manager

Ref: 26036 Thursday November 16th, 2017 - Online

Overview:   We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager.    Why should you Attend:  On average it takes ten successful projects to make up for one really bad ...

Education: Pharmacy, Medicine, Management, Public Health

Top 100+ Healthcare webinars You Can Get for $10

Ref: 25836 08/15/2017 -> 12/31/2018 - Online

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each. Regulatory compliance learning, that ...

Education: Pharmacy, Bio-Technologies, Computer science, Management