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Understanding Combination Products Requests for Designation and Product Jurisdiction
8/14/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA's Office of Combination Products.

Conference on Calculating Overtime Correctly under the Fair Labor Standards Act By Susan Desmond
8/21/2014 9:00 AM - 8/22/2014 5:00 PM
DoubleTree by Hilton Hotel Los Angeles Downtown Los Angeles, California United States
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Summary:

Overview:

For a law that has been around for so long, you would think that we would know what the FLSA means by now. Ever changing regulations and the multitude of suits being filed demonstrate otherwise. This webinar will go through all of the nuances of the FLSA and will cover the most frequent mistakes employers are making over and over again. We will discuss the employer/employee relationship under the FLSA, exemptions, what time is compensable, and ways to decrease your overtime liability and much more!

Areas Covered in the Session:

Understanding the employer/employee relationship under the FLSA.

Analysis of independent contractor v. employee.

Volunteers and trainees.

Exemptions - managerial, administrative, professional, outside sales, specific industry exemptions, the Motor Carrier Act

What is Working Time with discussion of the Portal to Portal Act.

New Requirements for Breastfeeding Mothers

Calculating Overtime Correctly - determining the workweek and calculations.

Using approved ways to reduce overtime liability - fluctuating workweek, Belo Plans, Union Employee Plans, compensatory time

Minimum Wage Requirements and handling of deductions like garnishments, employee theft, company equipment , etc.

Child Labor laws - when they can work, what they can do, what breaks are required

Recordkeeping Requirements

Call our representative on 1800 447 9407 to have your seats confirmed.

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Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@trainhr.com

Website: https://www.trainhr.com/

TrainHR

NetZealous LLC,

161| Mission Falls Lane| Suite 216, Fremont| CA 94539

What Employers Need To Know About Human Resources
8/21/2014 9:00 AM - 8/22/2014 6:00 PM
DoubleTree by Hilton Hotel Los Angeles Downtown Los Angeles, California United States
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Summary:

Overview:

This workshop will provide a comprehensive overview of all the key aspects of Human Resources. It will cover areas of compliance as well as best practices. You will receive a comprehensive workbook for the workshop and you will come away with Human Resource tools that you can start to use immediately upon your return to work that will add value to your organization. You will also come away with "best practices" in key areas such as Hiring, Termination, Discipline and Compensation.

Why should you attend:

Human Resource issues can make or break your business. Employment related laws are constantly changing and the penalties for non-compliance seem to be continually increasing. After this workshop you will have a much better understanding of all the basic employment laws that apply to businesses and be better able to avoid many of the pitfalls and traps that employers fall into that wind up in costly litigation and large amounts of lost time.

2 days in person seminar on Project Management in Human Resources By Cathleen M Hampton
8/7/2014 8:30 AM - 8/8/2014 4:30 PM
DoubleTree by Hilton Hotel San Diego Downtown San Diego, California United States
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Summary:

Overview:

Learn the imperative questions to ask before you even begin - get the information that will make certain you key in on what is expected, by when, and at what cost

Practice using the planning and scheduling tools that professional project managers use (GANTT charts, the critical path method, work breakdown structures, project management software, and others)

Discover the best practices for gathering your team, how to articulate the kind of skills, attitudes, and work habits you're looking for, and how to encourage your team to focus on your work and even a few ideas for how to deal with their rather reluctant bosses

Implement the controls and safety nets you need to establish early on: learn how to set (and meet) milestones, gain confidence to negotiate for new deadlines if necessary, motivate a team that's losing interest, and determine what to do when plans change midstream - or when the "Murphy factor" hits your project in a big way

Why should you attend:

Naturally, getting a project to deliver on time, within budget, and in line with quality standards requires savvy management. And, the bigger the project, the more challenging good management becomes. As a professional, you're expected to transform a vague concept into a measurable outcome by channeling a broad array of knowledge, skills, and resources toward a critical organizational goal.

Who will benefit:

Self-taught project managers seeking enrichment training and new skills

Project teams having trouble juggling their tasks and responsibilities

People with limited experience in spearheading a project

Anyone about to step into a project manager role for the first time

MultiState Payroll Compliance State Wage and Hours Conference By TrainHR
8/7/2014 8:30 AM - 8/8/2014 5:30 PM
DoubleTree by Hilton Hotel San Diego Downtown San Diego, California United States
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Summary:

Overview:

Will review the state wage and hour laws along with how to apply them with the federal wage and hour laws. Determining taxation and proper reporting will be reviewing. Polices on multi state taxation and hands on case studies will be done to enhance learning. Special situations and the states laws will be looked at to include deceased wages, unclaimed wages and employee overpayments. Garnishment state concerns will be talked about and what special garnishment reporting requirements that are necessary in some states.

Why should you attend:

Any employer that has employees in more than one state should attend this course. In 2 days the attendee will walk away with the data needed to understand how to process, tax and maintain employees in multiple states.

Day One

Lecture 1: State Wage and Hour

Lecture 2: State Garnishment/Levy Rules

Lecture 3: Special Wage Payments

Lecture 4: Special Wage Payments Con't

Day Two

Lecture 5: State Income Tax

Lecture 6: State Unemployment Tax

Lecture 7: State Disability & Local Taxation

Lecture 8: New Hire Reporting/State Sick Pay

Seminar on Family and Medical Leave Act
8/7/2014 9:00 AM - 8/8/2014 6:00 PM
DoubleTree by Hilton Hotel San Diego Downtown San Diego, California United States
Event Listing
Summary:

Overview:

The federal FMLA requires employers to grant eligible employees at least 12 weeks of unpaid medical leave in the event of an employee's serious illness or the serious illness of immediate family members. As much as 26 weeks of leave is available to families caring for certain military service personnel, in addition to leave to care for seriously ill or injured military personnel the FMLA. Military families may also get up to 12 weeks of leave for a "qualified exigency," which includes such circumstances as preparing for immediate deployment. FMLA leave can be taken in one continuous period of time or taken from time to time as needed.

The issues that arise for employers include knowing, among others, when an employee has a "serious health condition" as defined by law and not by the employer's doctor, when an employer can seek verification from a physician that the employee still cannot return to work, and what notices employers must provide and when.

This program is designed to provide an overview of the FMLA and the relevant regulations, to discuss amendments or modifications from the last few years, to discuss integrating FMLA with your other leave programs and to provide suggestions as to how to minimize employee abuse of this valuable benefit.

Why should you attend:

New developments include the application of the statute to same-sex couples (in at least16 states), expanded benefits for military families and clearer guidelines in the regulations.

Virtually every HR Director in a company of 50 or more employees will have to administer FMLA leave. One of the most common complaints among employers, however, is that some employees will seek to abuse FMLA leave. Such abuse can impose significant cost upon employers in terms of time and money.

Advertising and Promotional Requirements for Drugs and Medical Devices
8/7/2014 9:00 AM - 8/8/2014 6:00 PM
DoubleTree by Hilton Hotel San Diego Downtown San Diego, California United States
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Summary:

The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA").

Human Subjects Protection Two Day Seminar
7/24/2014 8:30 AM - 7/25/2014 5:30 PM
San Francisco, CA San Francisco, California 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 1: San Francisco | July 24th & 25th 2014| 8:30 AM to 5:30 PM

Venue: WILL BE ANNOUNCED SOON

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: WILL BE ANNOUNCED SOON

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 Applied Statistics for QA QC Manufacturing and Design Control
7/24/2014 9:00 AM - 7/25/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing
Summary:

This seminar provides a practical approach to understanding how to interpret and use a standard tool-box of statistical methods, including confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

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
Summary:

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

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