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« Thursday October 28, 2010 »
Thu
Quality System Regulation (QSR) Management Responsibilities - Webinar By ComplianceOnline
Start: 10/28/2010 8:00 am
End: 10/28/2010 9:15 am

 This (QSR) Quality System Regulation webinar describes management responsibility by reviewing the Quality System Regulation (QSR) and the reasoning that FDA published. It covers each of the components of management responsibility and provides a list of things you should consider in your implementation.
 
Areas Covered in the Seminar:

  • Valuable documents that provide understanding.
    • Quality System Regulation (QSR), including the definitions
    • QSR Preamble
    • FDA Paperwork Act submission for QSR (Quality System Regulation)
    • FDA’s Quality System Inspection Technique (QSIT) manual
    • Warning Letters
  • Subject Areas covered.
    • Quality policy
    • Organization
    • Responsibility and authority
    • Resources
    • Management Representative
    • Management review
    • Quality planning
    • Quality system procedures
  • For each subject area, the webinar includes information from the valuable documents listed above.

Related Technical Documents:

  • FDA QSR as published in 21 CFR Part 820
  • FDA QSR Preamble as published in 61 FR 52601-52662
  • QSR Paperwork Reduction Act Supporting Statement - OMB No. 0910-0073
  • Guide to Inspections of Quality Systems
  • FDA Warning Letters

 

Talend Open Profiler for Dummies
Start: 10/28/2010 10:00 am

This Tutorial live Will Present:

- Prerequisites – How to set up your PC for Talend
- How to download and install Talend Open Profiler
- What Data Sources and Data Types Can Be Profiled
- How to Profile Data in a Database
- Basic Concepts of Talend Open Profiler

A demonstration of several concrete cases will also be performed.

Date: November 28th
Time: 10am GMT
Register here: http://nxy.in/sxtqj

The Most Important Financial Decision Facing CNS Drug Developers: THE TRUE COST OF RISK
Start: 10/28/2010 11:00 am

Discussing a powerful economic tool that can help your CNS molecule survive portfolio review will be Dr. Bruce Leuchter, Assistant Professor of Psychiatry & Director, Clinical Neuropsychiatry and Neurostimulation Therapies at Weill Cornell Medical College and former Emerging Biotechnology Analyst at Goldman Sachs & Company. Bruce will be joined by MedAvante’s Chief Medical Officer, Dr. Mike Detke.

Hosted by MedAvante CEO Paul Gilbert, this webinar event will provide convincing evidence that selecting an effective strategy to reduce this risk represents the most important economic decision any clinical development leader will make, and a powerful way to impact the financial value of new drug candidates.

Tax Changes to Watch Out For
Start: 10/28/2010 11:00 am
End: 10/28/2010 11:50 am

In the spirit of Halloween, join us for this webinar and discover if you should be scared of these possible and impending tax changes.

Topics will include:

· Federal and State Cap Gains
· Private Transfer Fees
· 3.8% Real Estate Sales Tax
· Estate Taxes
· Dodd-Frank Consumer Protection Act
· And Many Other Tax Changes

The audio portion of the webinar will be broadcast over your computer's speakers and via telephone. You may choose to call in and ask questions or you may listen to the webinar over the internet and enter questions via text.

* Not permissible in all US jurisdictions

How To Create a Web Site in Record Time Using Wordpress.
Start: 10/28/2010 3:00 pm

B. Hopkins of Psiphon Consulting owner and creator of several wordpress blogs and author of more than 100 articles, teaches you HOW to easily enhance your Wordpress blog to drive more traffic easily to your website and WHAT you need to do to add the features and functions that will allow you to take maximum benefit from your blogging platform. You will learn the "must have" plugins and widgets that will help your blog become a full featured web site. As a Wordpress website owner, you will be able to easily maintain, and update your website and also be able to expand its functionality in the future should your business need to.

At the end of this session, participants will know how to:

1. How to set up a home page
2. How to set up a contact-us page
3. Find and install the plugin’s that they will need to get the best performance from their Wordpress web site
4. How to set up the menu's
5. What are widgets and which widgets to use for improved performance.

As an added bonus, the first 50 registrants will receive:

* Wordpress Website Secrets
* Video Recording of the Webinar

Suggested Attendees: Consultants, Entrepreneurs, Bloggers, Marketing professionals, Small business owners, and Web designers.

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