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2day Inperson Seminar on Advanced Course Validation and 21 CFR 11 Compliance of Computer Systems
7/24/2014 9:00 AM - 7/25/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing

This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools

Human Subjects Protection Ethical Research and Institutional Review Boards IRB s
7/24/2014 8:30 AM - 7/25/2014 5:31 PM
DoubleTree by Hilton Hotel San Francisco Airport 835 Airport Blvd San Francisco, California United States
Event Listing

Human Subjects Protection, Ethical Research and Institutional Review Boards (IRB) s


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 1: San Francisco | July 24th & 25th 2014| 8:30 AM to 5:30 PM

Venue: DoubleTree by Hilton Hotel San Francisco Airport

835 Airport Blvd, Burlingame CA 94010-9949

Price: $1,295.00

Register now and save $200. (Early Bird)

Until May 31, Early Bird Price: $1,295.00

From June 01 to July 22, Regular Price: $1,495.00

Location 2: Miami | September 18th & 19th 2014 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


Event Link:




Net Zealous LLC

43337 Livermore Common, Fremont CA 94539, USA

How to Get Your Combination Product Approved and onto the US Marketplace
8/14/2014 9:00 AM - 8/15/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing

This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

Oktane 14
11/10/2014 9:00 AM - 11/12/2014
Westin St. Francis Hotel San Francisco, California United States
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Oktane14 is the ultimate conference for today’s user-centric IT professionals. This year’s conference is designed to share major updates in the Okta service, explore cloud best practices with industry experts and discuss the impact of new trends in IT.

Health Innovation Summit
8/21/2014 - 8/22/2014
W Hotel, San Francisco San Francisco, California United States
Event Listing

Join us for our fourth annual Health Innovation Summit this August!

10/1/2014 9:00 AM - 10/3/2014 6:00 PM
Lobero Theater Santa barbara, California United States
Event Listing

ONTRApalooza is for the dreamers, the doers, the risk-takers and passionate innovators who devote everything they've got to building something remarkable that makes a real difference. ONTRApalooza is where your inner rockstar comes to jam with like-minded leaders, builders, and creators... on the sunny beaches of Southern California.

1 Million Cups Boulder myhub and RockPile Energy Services
7/23/2014 9:00 AM - 10:00 AM
Boomtown Boulder, Colorado United States
Event Listing

Join us for 1 Million Cups Boulder every Wednesday at 9 a.m. at Boomtown.

ProcuretoPay Fraud Detecting and Preventing Purchasing Receiving and Disbursement Fraud
7/31/2014 9:00 AM - 8/1/2014 6:00 PM
Hilton Garden Inn Denver Downtown Denver, Colorado United States
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Procure to pay is the target for fraudsters of many kinds both inside and outside your organization. Consider the possibility of receiving a perfectly legitimately-looking invoice which gets approved and processed before it is determined that the sender of the invoice is a "ghost" vendor with nothing more than a postal box for an address.

Or-the case of the large retailer whose Accounts Payable department honored the E-mail request of a "vendor" to switch from check payment to ACH payment, only to learn several millions dollars in fraudulent payments later, that the sender was a fraudster.

Why should you attend:

Understand how common procurement, receiving and disbursement frauds are perpetrated

Understand who the primary perpetrators of purchasing, receiving and disbursement fraud are

Understand why purchasing, receiving and accounts payable employees commit fraud

Learn how not to manage P2P from important case studies of frauds committing in this area

Recognize the red flags of common P2P frauds

Know how to apply best P2P fraud detection tools and techniques

Learn to correct P2P control deficiencies in favor of a robust anti-fraud control framework

1 Million Cups Denver Corporate Compassion Mad4charityorg and Simplur
7/23/2014 9:00 AM - 10:00 AM
Galvanize Denver, Colorado United States
Event Listing

Join us for 1 Million Cups Denver every Wednesday at 9 a.m. at Galvanize.

1 Million Cups Delaware RearVuenet
7/23/2014 9:00 AM - 10:00 AM
Delaware Technical Community College Georgetown, Delaware United States
Event Listing

Join us for 1 Million Cups Delaware every Wednesday at 9 a.m. at the Jack F. Owens Campus.

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