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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
8/27/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.

ICH GCPs and the Clinical Research Process Including Phase 0123 and Phase 4 trials
8/12/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar presents a comprehensive overview of the ICH GCP and other clinical requirements for conducting clinical trials. Learn about the ICH GCP, use of the ICH GCP during clinical trials and the general concepts upon which clinical trials are based. This webinar allows clinical professionals to prepare for and conduct clinical trials.

Key Concepts in Successful Water System Sanitization
8/5/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
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Summary:

This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization.

Measurement Uncertainty in Microbiology
8/18/2014 11:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the accreditation requirement for MU, including, what data to collect and how to analyze it. Also a practical step by step approach to data compilation specifically applicable to microbiology will be discussed.

Quality Management Systems Creating Implementing and Improving
8/14/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

All parts of the Pharmaceutical Quality System should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s). The basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management are inter-related.

The Most Common Problems with Software Validation Processes
8/20/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.

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
Event Listing
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
Event Listing
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
Event Listing
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

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