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« Week of October 24, 2010 »
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OnDemand Webinar: How to protect your enterprise data assets from risks and exposure during application testing
Start: 10/25/2010 8:41 pm

This webcast will focus on protecting data assets in enterprises while at the same time ensuring referential integrity for application testing using comprehensive data management strategy. As data in enterprises keep growing

* the costs for storage and IT resources keep increasing for application testing as well;
* it exposes enterprises to a constant risk of data privacy regulations.

In this session we will see how Solix Enterprise Data Management Suite (Solix EDMS) provides secure and rapid application testing that is built in partnership with Oracle and a seamless end-to-end integrated model for database subsetting, cloning and masking.

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Addressing corrosion on existing pressure equipment
all day

Time: 14:15 GMT

The majority of conventional maintenance is executed under a long term contract with a general contractor, who provides a wide range of services, fixing nearly all common repairs. However a few problems can only be fixed using a specialty high risk solution and that is where technology can bring value. Equipment upgrades also exceed maintenance services and require engineering support to define the best design: metallurgists, corrosion experts, FEA experts, welding engineers but also tooling engineering capacity.

Through a risk analysis process we can propose a technology based safer solution and provide a long term improvement on the critical corrosion issue of major components: safety in design, safety in execution, safety in service operation.

Featured case study:

A recently executed project with the most recent overlay technology used in situ on a distillation column suffering from corrosion on the shell. The specificity of this project is that another area of the same column was also suffering from corrosion and the shell has been replaced by windows in parallel with the overlay during the same turnaround.

The different steps of this project will be explained:

•Identification of the corrosion

•Selection of repair solution

•Selection of metallurgy

•Execution and safety

What will I learn?

•How technology can be utilised to repair and improve the reliability of existing major pressure and mechanical equipments

•Assess alternative solutions to the traditional maintenance approach and even more interesting solutions instead of replacing existing equipments due to process changes

•Optimise investment and improve the performance of production tools through innovating technology

Drug Safety Assessment and Risk Minimization in the Development Period - Webinar By ComplianceOnline
Start: 10/26/2010 10:00 am
End: 10/26/2010 11:00 am

 This drug safety training will discuss the various factors to be considered and the principles of risk assessment to be followed during drug development to minimize risk.
 
Areas Covered in the Seminar:

  • Risk conceptualization.
  • Goals of project risk management.
  • Risk management planning & safety review teams.
  • Intellectual property.
  • Pharmacovigilance planning in product risk management.
  • Unexpected study results: efficacy, dosage, adverse events & toxicology.
  • Data analysis, interpretation and presentation.
  • Essentials of Data Monitoring Committees.
  • Drug disposal and environmental impact.
  • Labeling as a hallmark of risk management efforts.
  • Post-marketing risk.

Who Will Benefit: The Webinar will present valuable risk management information and provide a familiarity with practices to mitigate risk by pharmaceutical and biotechnology personnel involved in drug development, including:

  • Project managers
  • Managers in drug development
  • Clinical research associates
  • Regulatory and safety managers
  • Compliance associates

 

Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step - Webinar By ComplianceOnline
Start: 10/26/2010 10:00 am
End: 10/26/2010 5:00 pm

 In this excel Spreadsheet validation full day webinar training, learn the best way to design and validate the excel spreadsheets. Learn what the requirements are of excel validation and how to implement it to comply with regulations.
 
Why Should You Attend:
Excel spreadsheets used in regulated environments should be validated and comply with other FDA requirements. In this interactive one-day on-line seminar Dr. Ludwig Huber will give an introduction to FDA, GAMP® 5 and other requirements for validation of excel sheet and present approaches for implementation. This is a comprehensive course covering validation, design, testing of functions along with how to apply risk based validation techniques for spreadsheet application. Learn best practices of document planning, specifications, installation, testing and changes.
Learning Objectives:

  • Understand regulatory requirements for validation and use of Excel spreadsheets.
  • Understand how to effectively design and develop Excel spreadsheets for compliance.
  • Learn how to effectively validate Excel spreadsheets.
  • Lean what and how to test for Excel spreadsheets.
  • Learn how to maintain spreadsheets in a validated state.
  • Learn how to document Excel spreadsheet validation for FDA and other regulations.

How It Works:

This excel validation virtual event has 6 modules. Our speaker will deliver the modules using PowerPoint slides. Practical examples, case studies and exercises will be dispersed into and between the presentations. About 50% of the time will be dedicated to discussions and practical sessions. As an example, attendees will receive fill-in templates to document validation steps from beginning to end, in other words, from validation planning and writing specifications to testing and writing the validation report. Application examples will be generic and easy to understand. The results will be discussed and conclusions will be documented by the presenter and will be available for download from a special reference website. Attendees can use the templates to validate and document their own Excel applications. At the end of each module participants can ask verbal questions through the audio line. Written questions can be submitted at any time.
 

The Basics of the 1031 Tax-Deferred Exchange
Start: 10/26/2010 11:00 am
End: 10/26/2010 11:50 am

This webinar will discuss the basics of the 1031 exchange process. Topics will include:

- Definition of a 1031 Exchange
- Like-Kind Defined
- Capital Gains & Boot
- Completing a successful 1031 Exchange
- Timeframes in a 1031 Exchange
- Selecting a Qualified Intermediary

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.

How to Treat Adult Children of Divorce (ACOD): Preventing Mistakes and Repairing the Damage
Start: 10/26/2010 12:00 pm

Post-divorce adjustment for adolescents and young adults facing the separation of their parents is both a surrealistic and confusing time. Family permanence shatters, the covenant of safety ends, feelings of victimization and abandonment intensify, and the expected new role of the offspring forces unwanted changes. As survivors, they become Adult Children of Divorce (ACOD). This workshop addresses this population’s self-defeating reactions to the initial shock and residual effects of divorce. It shows the productive steps available for better self-control and family reconciliation through evidence-based, behaviorally-based interventions that guide the ACOD into a transition of accepting and adopting healthier perspectives of their parents and selves.

What you will learn:
Examine the common problems adolescents and young adults experience when their parents divorce.
Describe the emotional and behavioral self-defeating side-effects of passive-aggressiveness.
Discover four easily implemented methods to reverse the ACOD’s thinking and restore familiar, positive, pre-divorce behavior patterns.

Technical requirements:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save time, you can setup prior to the meeting by following this link: https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php

Disclaimer:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event.

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Monitoring Impurities in Pharmaceutical Products to meet ICH Q3 A/B Requirements - Webinar By ComplianceOnline
Start: 10/27/2010 10:00 am
End: 10/27/2010 11:00 am

 This pharma training will discuss how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and learn how to measure the thresholds to report for regulatory submission.
 
Learning Objectives:
Upon completion of this session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities. Participants will gain practical knowledge about key considerations when reporting impurities for regulatory submission. This session will also discuss observations and infractions that were obtained due to recoding impurities in pharmaceutical labs.
Areas Covered in the Seminar:

  • Understand regulatory expectations.
  • Discuss warning letters and citations.
  • Understand regulatory requirement guidelines surrounding impurities in API and Drug Products.
  • Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products.
  • Understand different thresholds to report for regulatory submission.

Who Will Benefit:
To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

  • R&D analysts
  • QA and QC Managers
  • Regulatory scientists
  • Directors

 

QSR Device Inspections – Transition from “Barely Surviving” to “Gaining Control” - Webinar By ComplianceOnline
Start: 10/27/2010 10:00 am
End: 10/27/2010 12:00 pm

 This Medical Device Quality System training will discuss how to Create an adequate quality system that meets FDA’s requirements and Effectively prepare for upcoming Quality System Regulation (QSR) inspections.
 
Areas Covered in the Seminar:

  • Definition of Quality System Regulations (QSR).
  • Who must comply fully vs who is allowed to partially comply to QSR.
  • Definition of QSR’s four main subsystems:
    • Management Control
    • Corrective and Preventive Action (CAPA)
    • Design Controls
    • Production and Process Controls (P&PC)
  • Definition of Satellite subsystems.
    • Medical Device Reporting
    • Corrections and Removals
    • Medical Device Tracking
    • Sterilization Process Controls
  • Tips on establishing an effective quality system for the design, production and distribution of your device.
  • Overview of Quality System Inspection Technique.
  • Typical Quality System deficiencies noted in Warning letters.
  • Techniques used in inspection planning.
  • Factors involved in selection process.
  • Overview of FDA regulations and guidelines used for inspections.
  • Inspection documentation and proper follow-up procedures.
  • Tips for Preparing for Quality System Inspection/

 

The Case for Social Media Management and Archiving
Start: 10/27/2010 10:00 am
End: 10/27/2010 11:00 am

A live Webinar sponsored by FaceTime, Smarsh and Messaging News

Date & Time:

Wednesday, October 27, 2010
1:00pm EDT / 10:00am PDT / 18:00pm BST / 19:00 CET

Speakers:

  • Michael Osterman, Principal, Osterman Research, Inc.
  • Norv Leong, Product Marketing Manager, FaceTime
  • Sam Kolbert-Hyle, VP/Business Development & Strategic Initiatives, Smarsh

We will randomly select one registrant for this Webinar to receive an Apple iPad. The winner will be announced during the live event.

Register now for “The Case for Social Media Management and Archiving”

The use of social media in companies has literally exploded over the past few years in virtually every organization. Yet relatively few organizations understand how it is being used, many are taking on needless legal, compliance, and reputational risks, and most IT professionals have not made the return-on-investment case internally for social media management and archiving solutions.

Join us for a special Osterman Research and Messaging News panel Webinar focused on why organizations should monitor and archive social media content and how you can justify implementing a solution in your organization.

Attendees will be able to articulate the ROI case internally for archiving and risk mitigation arguments that should be used to help quickly gain control of social media content while still experiencing its benefits. Discover:

  • What are the risks associated with doing nothing to manage the use of these tools in a corporate environment?
  • What are the best practices around social media policies and options to consider for your organization?
  • What are some of the leading solutions available to help you manage and archive social media content, and to ensure that social media is not used in violation of corporate policies?
  • What are some of the key regulations which govern social media and its archiving?
  • What are the latest trends in social media and management and archiving of this content?

In short, understand why you need to archive and manage social media, how to make the ROI case for it internally, and have the opportunity to ask your top social media management questions of our experts.

Register now for “The Case for Social Media Management and Archiving”

FREE Webinar: Generate Quality Sales Leads Using Webinars
Start: 10/27/2010 11:00 am

Generate Quality Sales Leads
~Using Webinars

Webinars are a low cost way to generate qualified sales leads. Delivered as educational marketing, they also position you as an authority in your field, creating respect and instilling trust in your audience. Bottom line, it gives your sales efforts a running start.

What You Will Learn:
• The benefits of educational marketing
• The rules of lead generation webinar engagement
• The steps to create a well organized follow-up process
• The best methods to cost-effectively attract webinar registrants

Who Should Attend:
• Sales and Marketing professionals who know the value of their customer
• Management who wants their sales staff closing, not cold calling
• Executives who understand long-term leadsource ROI

All Attendees will receive: a copy of “40 FAQs About Lead Generation Webinars"

About the Presenter:
Don Cameron, Marketing Strategist and founder of Interactive Telesis and ConferTel, has helped hundreds of organizations generate non-dues revenue by delivering educational webinars to their members in addition to helping businesses use an educational marketing approach to cost-effectively generate qualified sales leads.

Webinar on Business Continuity with Virtualization on Oct 27, 2010
Start: 10/27/2010 11:12 pm

Register for the webinar on Business Continuity with Virtualization and how to maximize performance while Minimizing TCO on Oct 27th 2010. Once registered you will receive an email confirming your registration with information you need to join the Webinar.

Most IT managers are continuing to look for ways to save money in the IT enterprise. One of the chief concerns for IT professionals is implementing a Business Continuity/Disaster Recovery solution. This webinar is designed to show you how to manage Business Continuity with Virtualization.

Raj Kosuri, CTO and Terell Jones Director of Infrastructure for Ecomnets, the industry's leading authorities on Green IT infrastructure design and management will discuss:
• Why use virtualization as a business continuity strategy?
• How does it maximize performance?
• How does it minimize TCO?

Who Should Attend: Professionals new to virtualization including: CEO, CIO, CTO, CFO, CSO, COO, IT Managers, Data Center Managers, Facilities Managers, Business Managers

About EcomNets:

EcomNets Green IT Solutions can help you save energy costs, save cooling costs, and reduce your carbon footprint. EcomNets are experts in PC Power Management, Virtualization, Cloud Computing, Data Center Best Practices, and Electronic Waste Management. EcomNets can help you easily develop a Green IT strategy compatible with your business processes. EcomNets Green IT Solutions delivers fast, flexible, and affordable solutions, helping you drive consistent and measurable improvements in your Green IT Initiatives.

www.EcomNets.com

Register for a session now by checking a date below:

Wed, Oct 27, 2010 11:00 AM - 12:00 PM EDT
https://www1.gotomeeting.com/register/238994081

Wed, Dec 1, 2010 11:00 AM - 12:00 PM EST
https://www1.gotomeeting.com/register/869060065

Wed, Jan 12, 2011 11:00 AM - 12:00 PM EST
https://www1.gotomeeting.com/register/210026305

Once registered you will receive an email confirming your registration with information you need to join the Webinar.

28
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

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

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.

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.

29
An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 - Webinar By ComplianceOnline
Start: 10/29/2010 9:00 am
End: 10/29/2010 10:15 am

 This Integrated Risk Management Approach training in ISO 14971 will discuss how to incorporate risk management as per ISO 14971 in all phases of medical device development and what all documentation to be gathered to support the decisions made as a part of risk management process.
 
Areas Covered in the Seminar:

  • How are risk management activities integrated throughout the development process.
  • The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process.
  • How to control and verify risk mitigations.
  • How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards.
  • The importance of maintaing Risk Management documents in the Post Production era.
  • What information to include in the Risk Management Plan and Report for better auditability.

Who Will Benefit:
This webinar will provide a methodology that medical device companies can use in establishing a risk management process that is integrated with their product development process. The employees who will benefit include:

  • Systems engineers responsible for developing requirements
  • Software developers
  • Test Engineers
  • Quality System auditors
  • Engineering managers and personnel
  • Regulatory Affairs

 

Key Considerations in Verification & Validation of Medical Devices - Webinar By ComplianceOnline
Start: 10/29/2010 10:00 am
End: 10/29/2010 11:00 am

 This Verification & Validation training for medical device will dissect some of the FDA 483 observations related to design verification and design validation and teach you how they can be prevented.
 
Areas Covered in the Seminar:

  • How to properly plan Verification and Validation activities.
  • Verification & Validation testing throughout the product life cycle.
  • How to determine sample sizes needed for testing.
  • What is appropriate objective evidence.
  • How to perform regression analysis.
  • What is meant by Production Equivalence.
  • How do we validate test methods.
  • Special considerations for software based products.

Who Will Benefit:
This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include:

  • Systems engineers responsible for developing requirements
  • Software developers
  • Test Engineers
  • Quality System auditors
  • Engineering managers and personnel

 

Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES - Webinar By ComplianceOnline
Start: 10/29/2010 10:00 am
End: 10/29/2010 11:00 am

This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.
Areas Covered in the Seminar:

  • Important factors to know in order to use Comparability Protocols:
    • What are Comparability Protocols?
    • What are the benefits of using Comparability Protocols?
    • When might a Comparability Protocol be useful for a CMC Change?
    • What about pre-approval changes?
    • When might a Comparability Protocol be inappropriate to use?
    • How should a Comparability Protocol be submitted?
    • What happens after submission?
    • What are the basic elements of a Comparability Protocol?
    • How much Risk Potential can be reduced by using a Comparability Protocol?
    • New and expanded uses for Comparability Protocols.

For More Details :

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701315?channel=webcentral
Contact Number: 650-620-3915
Email: admin@complianceonline.com

Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations - Webinar By ComplianceOnline
Start: 10/29/2010 10:00 am
End: 10/29/2010 11:00 am

 This contamination control webinar will discuss how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical and how it can be addressed in developing a successful contamination control program.
 
 
Areas Covered in the Seminar:

  • Developing effective ways to address spore excursions.
  • Troubleshooting real world experiences.
  • Developing preventative action plans.
  • Learn ways to improve facility design and maintenance.
  • The most effective sporicidal chemistries will be discussed in detail.
  • Cleaning and Disinfection Methods will be addressed.
  • Warning Letters and 483’s from FDA will be discussed and addressed.

Who Will Benefit:

  • QA and QC Managers
  • Disinfectant Validation Managers
  • Operations Managers
  • Cleanroom Managers
  • Personnel and contractors that clean and disinfect cleanrooms
  • Regulatory Compliance Managers & Environmental Monitoring Managers
  • Production Managers
  • Cleanroom Operators

 

30
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