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Webinar On How to Develop a Master Validation Plan
1/27/2015 1:00 PM - 2:00 PM
Online Mississauga Canada
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Summary:

This webinar on “How to Develop a Master Validation Plan” (also known as Validation Master Plan) will provide a step-by-step procedure for all medical device companies and their suppliers that are in need of developing a plan for product/equipment transfer, facilities, processes or to develop a company standard.

Webinar On Building a Compliant Documentation and Training System
1/26/2015 1:00 PM - 2:00 PM
Online Mississauga, Ohio Canada
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Summary:

This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective compliance documentation that meets both regulatory and training purposes.

Webinar On What is the harm in that Risk Management 101
1/22/2015 1:00 PM - 2:00 PM
Online Mississauga, Ohio Canada
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Summary:

A Highly regarded talk during recently held ASQ World Conference on Quality and Improvement. This course is meant to be a needed introduction to risk management for a broader range of professionals.

2day Inperson Seminar on Basics of US Medical Device Regulation at SFO CA
1/22/2015 9:00 AM - 1/23/2015 6:00 PM
DoubleTree by Hilton Hotel San Francisco Airport San Francisco, California United States
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Summary:

Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device!

2day Inperson Seminar on FDA Device Software Regulation at Los Angeles
1/22/2015 9:00 AM - 1/23/2015 6:00 PM
DoubleTree by Hilton Hotel Los Angeles Downtown Los Angeles, California United States
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Summary:

Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment.

Make IT Happen Organization Design Essentials for IT Executives IT seminar
1/22/2015 9:00 AM - 1/23/2015 6:00 PM
Hilton Grand Vacations Suites at the Flamingo Las Vegas, Nevada United States
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Summary:

According to studies, about two thirds of IT projects fail in some important way: time and budget overruns, terminations, or all of these. This is a universal problem, whose economic impact is at around three billion dollars, or close to 5 per cent of global GDP. These project failures are actually increasing, because projects are getting bigger and more complex. Large IT projects are 20 times more likely to fail than large projects in other sectors, such as construction.

Any change process should integrate the technical, commercial and social aspects, yet IT-projects are often managed merely from the technical and commercial perspective, while the social aspect is not adequately addressed. This is one of the root causes of IT failures. However, with even a modest attention to how IT function and IT projects are organized, governed and managed, improvements in the success rate of IT can be attained.

The seminar is well suited for chief information officers, other senior IT managers, and IT program/project managers, who aspire to develop their IT organization and projects. The models, methods and tools suggested in the seminar are research-based and tested in the field.

Rossana Berardi presenting How to Design and to interpret a Clinical Trial in The Targeted Therapies
1/22/2015 9:00 AM - 1/23/2015 6:00 PM
Hilton Grand Vacations Suites at the Flamingo 3575 Las Vegas Boulevard South, Las Vegas, Nevada las vegas, Nevada United States
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Summary:

Areas Covered in the Session:

• Traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints...)

• Introduction of targeted therapies in the Oncology field and of the related different needs (i.e. identification and validation of biomarkers). Examples will be provided about the most important types of tumors (lung cancer, colorectal cancer, breast cancer), as well as the more rare diseases.

• Analysis of the new endpoints related to the different mechanism of action of the new therapies will be provided.

• Requirements of the regulatory authorities, with a special focus on the rebounds in the European and Italian System (with examples of major criticisms of some relevant trials)

• Meaning of the terms deviation, violation and exception and their impact on the clinical trials conduction and results.

• Phase III statistical design of clinical trials in Oncology, in particular with new drugs (analysis of recent examples of phase III trials which present limitations).

Marketing Made Lean
1/22/2015 6:00 AM - 2/12/2015 10:00 AM
Fox Valley Technical College D.J. Bordini Center Appleton, Wisconsin United States
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Summary:

Solidify your value proposition and align products/services with meeting customer’s needs, wants or jobs to be done. Identify current and potential customer segments, and learn to identify customers based on the 80/20 Principle to your marketing resources while driving sales and profits. Explore and develop your marketing channels and create customer service strategies.

Webinar On US FDAs Strategic Priorities 2015 and Beyond
1/21/2015 1:00 PM - 2:30 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety.

Webonar on Design Inputs Design Outputs Traceability Matrix Principles of Lean Documents
1/21/2015 1:00 PM - 2:30 PM
Online Bakersville, Ohio Canada
Event Listing
Summary:

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.

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