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Webinar On Risk Management Principles
9/15/2014 1:00 PM - 2:00 PM
Online Mississauga Canada
Event Listing
Summary:

This course provides an understanding of the basic principles and background to risk management, which an essential basis for any other activities where a ‘risk based approach’ is required.

Hack Night
9/16/2014 5:00 PM - 9:00 PM
Assembly Coworking Space Calgary Canada
Event Listing
Summary:

Every Tuesday night from 6pm to 10pm, “Hack Nights” come alive with hustlers, hackers and hipsters coming together to work on their start-up ideas. If you are working on something tech related, and are in the pre-investment stage, this event is for you!

Weekly Open Make Night
9/16/2014 6:00 PM - 9:00 PM
Tampa Hackerspace Tampa, Florida United States
Event Listing
Summary:

Lets get together to build some cool projects and meet some very cool people. Join us to work on your stuff, bounce ideas off of members and socialize.

Occasionally, we'll throw in a small class.

FXBG Design
9/16/2014 6:30 PM - 8:30 PM
LibertyTown Arts Fredericksburg, Virginia United States
Event Listing
Summary:

FXBG Design is a meetup group for local designers & creatives to hang out, collaborate on projects, share feedback, develop professionally, and help build the Fredericksburg design community.

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
Event Listing
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.

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

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