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Business Glossary First step to Data Governance Success Webinar By EITAGlobal
9/17/2014 10:00 AM - 1:00 PM
Online seminar Fremont, California United States
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Summary:

Overview: Often organizations are challenged in selecting the first enterprise wide implementation that the Data Governance (DG) program should address. A Business Glossary is a great first initiative as well as one that provides significant value to the enterprise.

A Business Glossary is the tool for exposing authoritative content from DG initiatives and used to communicate understanding and clarity across the enterprise. A business glossary can connect workers across the enterprise to critical business information they can trust, helping to eliminate misunderstandings that cause lost time, lost opportunities and lost revenue. Creating great definitions and business term names will aid significantly in enabling search capabilities. The Business Glossary should be an early deliverable from your DG program and mature to include the logical and physical data constructs as a valuable component to drive DG maturity and value.

This seminar will be helpful for data management and Governance professionals that have been challenged with any of the following issues:

How to organize the business glossary program for quick wins as well as position for a maturing DG program

Business Intelligence, BPM and KPI ambiguity

Legal and compliance regulations are driving new projects that are not clearly defined (such as TART)

Enterprise or international projects like CDI/MDM that must address terminology and semantic differences across the enterprise

Why should you Attend: Often organizations are challenged in selecting the first enterprise wide implementation that the Data Governance (DG) program should address. A Business Glossary is a great first initiative as well as one that provides significant value to the enterprise. A Business Glossary activity, when addresses as data sprints, can provide the DG program with effective and quick success, as well as great visibility for the program.

Good Governance processes are critical for many enterprises that are:

Unclear how to achieve quick results from Data Governance

Organized geographically introducing global enterprise semantic differences

Challenged by complexity of terminology having many glossaries

Mergers and Acquisitions have introduce semantic differences across the enterprise

Areas Covered in the Session:

Methods for establishing the Business Glossary, standards and best practices

How to leverage your existing Governance team and processes

How to create structured definition standards and name business terms

Techniques to get your Glossary populated and used

Who Will Benefit:

CDO and Director of Data Governance

Data Stewards

Data Governance Analysts and Data Governance team members

Data Architects

Speaker Profile:

Lowell is recognized as a thought leader in business metadata/glossaries, enterprise application integration, DW/BI applications, and Data Governance having hands-on experience with over 80 business intelligence implementations. He has also been recognized by W. H. (Bill) Inmon, and is a contributor to six of his books. Mr. Fryman is a co-author of the book “Business Metadata: Capturing Enterprise Knowledge”. Lowell an Data Architect in the Healthcare Practice of Edgewater Technology Inc. Lowell has achieved a number of certifications including Certified Business Intelligence Professional (CBIP) for ICCP/TDWI and has an MSIT degree.

Online training on FDA compliance organizational change management when automating processes
9/17/2014 10:00 AM - 11:00 AM
Online Event Phoenix United States
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Summary:

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system as changes are made.

Webinar on How to Implement HIPAA Requirements in GxP Regulated Establishments
9/17/2014 1:00 PM - 1:30 PM
Online Mississauga Canada
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Summary:

This webinar will explain HIPAA and the impact of HIPAA to the Life-sciences Industry, followed by explaining how to leverage the GxP work that a company already has, to create a cost effective approach to complying with both GxP and HIPAA requirements.

Clinical Research Foundation for the Application Concepts and Theories
9/18/2014 8:30 AM - 9/19/2014 5:30 PM
Courtyard Miami Downtown Miami, Florida United States
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Summary:

Overview:

This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

Why should you attend:

For those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information, protection of human subjects and all that this topic encompasses is imperative to know as there federal regulations that must be followed. In addition to federal regulations, there are state statues, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research so that it not only meets the regulatory requirements but so that the study is conducted in an ethical manner containing adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research. Guidelines also provide interpretation of the regulations which are not always as clear as they might appear upon first reading them. Attendance at this two day session will not only provide an introduction or refresher of the regulations, it will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participate signed an outdated consent document, etc.) when conducting human subjects

Areas Covered in the Session:

• Department of Health and Human Services regulations, 45 CFR 46

• Office for Human Research Protections Guidance

• The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814

• HIPAA and Hi-Tech

• ICH E6 Good Clinical Practices

• Coercion vs. undue influence

• Recruitment of Research Subjects

• Vulnerable populations

• Non-English speaking populations

• Inclusion of Women and Minorities

• Waivers of consent

• Waivers of consent vs. waivers of authorization

• Assent vs. consent

• Wards of the State

• Certificates of confidentiality

• Levels of de-identification what they are and how they affect consent

• Privacy vs. confidentiality

• Study responsibilities: ICH vs. NIH

• Drug/Device Accountability

• Codes of Conduct

• Conflicts of Interest

• Reporting responsibilities

• Monitoring

• Investigator-sponsor responsibilities

• Study types

• Special concern studies

• Standard operating procedures vs. protocol vs. IRB submission

• Common compliance issues

• Data safety monitoring

• Adverse event monitoring and reporting including Serious adverse events and unanticipated problems

• Investigational Drug and Device use in clinical trials

• Assurances and Agreements (e.g. MOU)

• Site Responsibilities

• International Ethical Guidelines

• Applying ICH to international sites

Who Will Benefit:

• Principal Investigators / Sub-investigators.

• Clinical Research Scientists (PKs, Biostatisticians,)

• Safety Nurses

• Clinical Research Associates (CRAs) and Coordinators (CRCs)

• Recruiting staff

• QA / QC auditors and staff

• Clinical Research Data managers

• Human Research Protection professionals

Course Outline:

Day 1 – Agenda

Lecture 1: The Evolution of Human Experimentation Regulation and Overview of Clinical Research and Ethics in Human Research

Lecture 2: Current Federal Regulations and Agencies involved in Human Research

Lecture 3: Selection and Recruitment of Research Subjects

Lecture 4: Informed Consent in Clinical Trials

Lecture 5: Confidentiality of Clinical Trial Information

Lecture 6: The Investigator

Lecture 7: Research Protocols

Day 2 – Agenda

Lecture 8: Multisite, Community and Collaborative Studies

Lecture 9: The Institutional Review Board

Lecture 10: Patient Safety in Clinical Trials Research

Lecture 11: Research Under the Food, Drug & Cosmetic Act

Lecture 12: International Research

Lecture 13: Compliance and Human Research

Lecture 14: Accreditation and Risk Management in Clinical Trials

About Speaker:

Sarah Fowler-Dixon Education Specialist and instructor, Washington University

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, and submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

Date, Venue & Price:

Location: Miami | September 18th & 19th 2014 | 8:30 AM to 5:30 PM

Venue: Courtyard Miami Downtown

200 SE Second Avenue - Miami, Florida 33131 USA

Price: $1,295.00 Register now and save $200. (Early Bird)

Until July 15, Early Bird Price: $1,295.00

from July 16 and September 16, Regular Price: $1,495.00

Event Coordinator

Toll free: 800-385-1607

Fax: 302 288 6884

Email: support@mentorhealth.com

Event Link: http://bit.ly/RDgVcb

Website: http://www.mentorhealth.com

LIVE CHAT SUPPORT -http://www.mentorhealth.com/chat/client.php?

MentorHealth

Net Zealous LLC

43337 Livermore Common, Fremont CA 94539, USA

2day Inperson Seminar on GMP Compliance for Pharmaceutical Quality Control Laboratories
9/18/2014 9:00 AM - 9/19/2014 6:00 PM
Hilton Hotel Berlin Berlin Germany
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Summary:

This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirements of the pharmaceutical QC laboratory. The instructor will present different areas of work with a "how to" approach so that the seminar participant can see how the subject matter applies to the participant's work either now or in the future.

2day Inperson Seminar on GMP Compliance for Pharmaceutical Quality Control Laboratories in Berlin
9/18/2014 9:00 AM - 9/19/2014 6:00 PM
Hilton Hotel Berlin
Event Listing
Summary:

This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations.

Make Lehigh Valley Open Hack
9/18/2014 6:30 PM - 9:30 PM
Makerspace of Hive 4A Allentown, Pennsylvania United States
Event Listing
Summary:

Open Hack Nights provide an opportunity for folks who are interested in learning more about Make Lehigh Valley and the Hive4A MakerSpace to come on out and join in the fun! FAQ for first-time hackers.

Downtown Podcast
9/18/2014 9:00 PM - 10:00 PM
Ogden Las Vegas, Nevada United States
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Summary:

Want to know what’s happening in Downtown Vegas and #VegasTech? Come see the Downtown Podcast team tape the weekly podcast LIVE!

Building an Information Technology Roadmap Webinar By EITAGlobal
9/23/2014 10:00 AM - 11:30 AM
Online seminar
Event Listing
Summary:

Overview: All enterprises, except the smallest ones, need to define, control and execute a series of actions or projects to support the business with appropriate information technology and systems.

A good IT roadmap needs to meet several demanding requirements:

It must be sufficiently high-level to be discussed with business stakeholders

Each action/project must have a clear justification

It needs to be realistic - you cannot do everything at once

It needs to be clear and detailed enough for IT people so they can clearly understand what to do to fulfill it

It must evolve as conditions change, and it must be kept up-to-date through these changes

It needs to incorporate the capabilities offered by new technologies without seeming to be "technology for technology's sake"

A roadmap driven by an understanding of Enterprise Architecture (EA) allows IT to describe and maintain the connection between the various levels of concern: business capabilities and business processes, business systems/applications, and the technical infrastructure. Therefore, it allows the organization to justify and prioritize each IT project. The development of the actual roadmap is a serious and intense exercise - something that may take at minimum a couple of person-months, and much more if there is little prior information about the existing portfolio and the business requirements. In this webinar, we describe a systematic approach that allows the development of the roadmap.

Depending on the existing level of knowledge, a systematic education effort may need to be provided on the concepts and frameworks for Enterprise Architecture, including Zachman and TOGAF. In particular, the TOGAF Architecture Development Method (ADM) is usually relevant to most organizations. At the same time, TOGAF is a very complex framework, and it is not necessary to master it in its entirety to correctly define an IT roadmap.

Next, the entire IT organization, as well as its business partners, and in particular the people who will be tasked with developing the roadmap, need to understand, tailor if necessary, and document the various levels of the enterprise architecture, starting with the business strategy and the value streams at the top, and going all the way to the infrastructure layers. There will be IT roadmap elements at almost every level, except the top-most ones which are the responsibility of the executive management, but everything else needs to be well positioned and well aligned in the roadmap.

The outcome of the process should be (a) a living document, easy to communicate and review, that both the business and IT can use to prioritize and monitor their actions, (2) a list of "follow-on" projects that will need to be performed in order to place the entire range of IT efforts on a solid basis; these projects may include the institution of a Product/Project Portfolio Management system, the creation of a business process center of excellence, the convergence of multiple redundant systems, the retirement of legacy systems, the externalization of certain capabilities (outsourcing, cloud, or BPO), the creation of an Enterprise Architecture Program, a Master Data Management program, a technology watch program, and more.

Why should you attend: All enterprises, except the smallest ones, need to define, control and execute a series of actions or projects to support the business with appropriate information technology and systems. Several difficulties immediately appear when the CIO or IT Manager attempts to define such a roadmap:

How do you take the business strategy, as defined by C-level executives, and derive from it a set of actions?

How do you engage with business people to review and agree on that roadmap, given that business managers often do not understand the technology, IT people do not speak in business terms?

How do you deal with the ever-increasing complexity of IT?

How do you handle legacy systems, especially after mergers and acquisitions?

A good IT roadmap needs to meet several demanding requirements:

It must be sufficiently high-level to be discussed with business stakeholders

Each action/project must have a clear justification

It needs to be realistic - you cannot do everything at once

It needs to be clear and detailed enough for IT people so they can clearly understand what to do to fulfill it

It must evolve as conditions change, and it must be kept up-to-date through these changes

It needs to incorporate the capabilities offered by new technologies without seeming to be "technology for technology's sake"

Many organizations conduct projects in isolation from each other, without having a clear view of where they are going. With this approach, you can run in circles or hit a wall. Other organizations dive down immediately to the level of detailed project plans, which are useless beyond a short-term horizon. Yet others have an IT roadmap or plan that is disconnected from the business strategy and requirements, so that it is hard to justify the cost of the projects to the business. Clearly, a more systematic and well-grounded approach is required.

Areas Covered in the Session:

Introduction

Challenge and Objective of a Roadmap

Key Enterprise Architecture concepts

Obtaining business inputs

Value streams or end-to-end processes

Business capabilities

Business system evolution and convergence

Technical Architecture elements of the roadmap

Creating the Roadmap: practical advice

Execution and governance

Follow-on projects

Who Will Benefit:

CIO

IT Manager (reports to CIO)

Business Architect

Enterprise Architect

Senior IT Consultants

IT Project Managers

Project Management Office (PMO)

Dynamic APIs and Dynamic Schemas The Secrets of Building Inherently Flexible Software
9/23/2014 10:00 AM - 11:30 AM
Online seminar Fremont, California United States
Event Listing
Summary:

Overview: The central technical challenge for Agile Architecture is how to achieve functionality and performance without having to trade off flexibility. The context for these central patterns of Agile Architecture is the concept of architecting at a dynamic level of abstraction above the logical level of contracted APIs and data schemas.

At this dynamic level, there are the central patterns that are essential to resolving the fundamental compromise of distributed computing:

Dynamic Coupling. Tightly coupled interfaces require detailed knowledge of both sides of a distributed computing interaction, and any change on one side might break the other. Contracted interfaces introduce loose coupling, but at the expense of a static interface. With dynamic coupling, interface differences are resolved dynamically at run time.

Dynamic Schemas. Neither the WSDL files that specify Web Services, nor the URIs, HTTP verbs, and Internet Media Types that specify RESTful APIs adequately contract the message semantics for any interaction. Dynamic schemas abstract all semantic metadata in a consistent way, relying once again upon the integration engine to resolve these dynamic schemas for each interaction at run time.

Extreme Late Binding. SOA registries ended up doing little more than resolving endpoint references at run time, similar to the way DNS resolves domain names - in other words, they provided late binding. Such late binding adds some flexibility to an interaction, but typically at the expense of performance. Today, however, dynamic coupling and dynamic schemas enable any client to discover at run time all the metadata it requires to interact with any endpoint, without sacrificing performance - what we call extreme late binding.

Put these architectural principles together and you have an approach for building inherently flexible software, even in a complicated distributed computing environment.

Why should you attend: The central challenge of distributed computing is how to get your various distributed bits to communicate with each other properly. Since those distributed components are typically heterogeneous, we must somehow come up with a common means of establishing interaction among components everybody can agree on. Yet, once we do that, we've necessarily compromised on flexibility, because changing how our components interact is a difficult, complex endeavor. This problem pervades the entire history of APIs, from remote procedure calls to Web Services to RESTful APIs and everything in between. We must somehow contract interfaces in order to abstract the underlying functionality, yet the very act of introducing such contracts is a compromise, since the interface itself now lacks flexibility.

Areas Covered in the Session:

Review of Web Services and RESTful APIs

Limitations of contracted interfaces

Challenges of document style services

Challenges of custom media types

Meta, Dynamic, and Logical abstractions

Data, metadata, and code at the Meta level

Working with abstract models

The role of the business agility platform

Agent-Oriented Architecture

Capabilities vs. Affordances

Implementing dynamic coupling

Implementing dynamic schemas

The role of extreme late binding

Who Will Benefit:

Enterprise Architects

Integration Architects

Software architects

Integration engineers

SOA specialists

Software developers

System Architects

Solution Architects

IT managers

Speaker Profile:

Jason Bloomberg is the leading expert on Digital Transformation through architecting agility for the enterprise. As president of Intellyx, Mr. Bloomberg brings his years of thought leadership in the areas of Cloud Computing, Enterprise Architecture, and Service-Oriented Architecture to a global clientele of business executives, architects, software vendors, and Cloud service providers looking to achieve technology-enabled business agility across their organizations and for their customers. His latest book, The Agile Architecture Revolution (John Wiley & Sons, 2013), sets the stage for Mr. Bloomberg’s groundbreaking Agile Architecture vision.

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