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« Wednesday August 29, 2012 »
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Online Seminar Software

The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic.

How to Setup the Software.
Cost of the Software
Usage in the Sales and Marketing area.

The Webinar will held on request, the duration is approx. 30 Minutes

Further Information to the Online-Seminar

(QMS) Competence and Training Requirements per FDA QSR and ISO 13485
Start: 08/29/2012 8:00 am
End: 08/29/2012 9:30 am

This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

Description:
FDA QSR states, “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” The corresponding requirement in ISO 13485 and ISO 9001, says, “Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience”.

An FDA Inspection or a Notified Body audit will cover the methods you established to determine competency, evaluate employees, and take actions. All of these activities require objective evidence, in the form of records, to demonstrate your QMS operation.

Learning Objectives:
* State the four elements of competency.
* State the definitions and the “official” sources.
* Describe the contents of a job description.
* Understand the elements of a competence gap analysis.
* Describe the content of a training record and its relationship to competency.

Conducting Legal and Effective Behavioral Interviews
Start: 08/29/2012 10:00 am
End: 08/29/2012 11:00 am

In this webinar, HR professionals, and managers can learn how to prepare, conduct, and evaluate behavioral interviews when hiring or promoting employees; to eliminate subjective hiring decisions and increase effectiveness and validity in the selection process while following legal guidelines

Why Should You Attend:

Have you ever been completely blind-sided by a job candidate? In the interview he seemed perfect; once hired, he was a disaster.

In this program, Judi addresses both the art and science of effective behavior interviewing. You’ll learn how to prepare for an interview and ask behavior-based questions that enable you to determine the candidate’s abilities based on their past performance. We will discuss how to resist the allure of the flashy job candidate who looks and sounds good in the interview, but turns out to deliver much less on the job. You’ll learn how to avoid the mistake of dismissing quiet candidates just because they don’t may a great first impression. You’ll also learn how to work with a panel of raters to come up with an objective measurement tool that uses past behavior as the best predictor of future workplace performance.

Areas Covered in the Seminar:

  • Determine the interview format and select the interviewers.
  • Define the required selection criteria.
  • Prepare the interview questions and interview guide.
  • Avoid illegal or leading questions.
  • Assign interview roles & the order of the questions (if team interview).
  • Ask questions based on the resume.
  • Ask behavior based questions.
  • Ask spin-off questions.
  • Answer the candidate's questions.
  • Take effective interview notes.
  • Avoid interviewer traps.
  • Close the interview on the right note.
  • Utilize objective evaluation tools.

Event Details:

Date: August 29, 2012
Time: 10:00 AM-11:00 AM PDT
Cost: $149 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.

Project Management for Computer Systems Validation - Webinar By GlobalCompliancePanel
Start: 08/29/2012 10:00 am

Overview: Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.

This class, will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Areas Covered in the Session:
FDA Inspections - background
Causes of Form 483 / Warning Letter
Some recent results of companies failing to respond appropriately
Best Practices for Responding to 483
Best Practices for Responding to Warning Letter
What to do if the responses fail

Who Will Benefit:
Project Managers
IT Management
Business Process Owners
Quality Managers
Quality Engineers
GxP
Consultants

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia.

Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel
Start: 08/29/2012 10:00 am

Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success.

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.

Areas Covered in the Session:
Understand the basic water system sanitization concepts
Use this understanding to design effective microbial control measures for your water systems
Use this understanding to solve microbial problems originating from poor sanitization practices
Debunk a few water system myths related to sanitization

Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:
Engineers involved in water system design
Utility operators and their managers involved in maintaining and sanitizing water systems
QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels
QA managers and personnel involved in investigations of excursions and preparing CAPAs
QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
Validation managers and personnel
Consultants and troubleshooters

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations, and has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience. During his 31+ year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter <1231> which many consider to be USP's "pharmaceutical water bible".

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Developing and Implementing a Practical Noise Monitoring Strategy
Start: 08/29/2012 10:00 am
End: 08/29/2012 11:05 am

This webinar will build upon a basic knowledge of noise monitoring and hearing loss to help in understanding the instruments used in performing noise monitoring and how best to use them in developing and implementing a practical strategy for performing noise monitoring.

Why Should You Attend:

This webinar starts with basic knowledge of sound and noise as well as its effects on hearing and exposure standards. It uses this basic knowledge to help in understanding the instruments used in performing noise monitoring and how best to use them in developing and implementing a practical strategy for performing noise monitoring. General categories of noise monitoring equipment presented and discussed include dosimeters, sound level meters and octave band analysis. The uses and application of these instrument types in performing noise monitoring for personnel protection is the primary focus of this webinar.

Included in this discussion are the effects of the time variability of noise sources and varying worker job duties in selecting suitable populations for exposure monitoring. This will aid in the development of a cost-effective yet practical strategy for monitoring occupational noise consistent with prevailing standards of practice.

This session will benefit all functional groups who have the need to understand the basics of noise, hearing loss and hearing protection as well as those responsible for noise monitoring for personnel protection and engineering control design.

Areas Covered in the Seminar:

  • What is noise?
  • How does noise affect hearing?
  • How is noise measured?
  • What are the exposure limits for noise?
  • How to assess occupational exposure?
  • Instrument types – strengths and weaknesses.
  • How to select a sample population?
  • Monitoring methods.
  • Interpreting your monitoring results.

Event Details:

Date: August 29, 2012
Time: 10:00 AM-11:05 PM PDT
Cost: $149 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.

Recognizing and Responding to Stalking
Start: 08/29/2012 1:00 pm

During this one-hour webinar, participants will gain valuable insight into stalking behavior and the reactions of stalking victims. Current research will be discussed as well as helpful resources for assisting victims of stalking.

Full Description:
Stalking is one of the most pervasive and serious public health issues facing the United States today. One in four women and one in thirteen men report having been a victim of stalking during their lifetime in which they felt fear. Recognizing and Responding to Stalking will enhance participants' understanding of stalking by providing information about common stalking behaviors, reviewing key findings from the research on stalking, identifying common reactions experienced by victims, and discussing ways to assist victims of stalking.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Define stalking
Recognize common stalking behaviors
Identify who is most at risk for stalking victimization
Examine some of the common reactions of stalking victims
Discuss strategies to assist victims of stalking

Your Presenter:
Erika Smith, MS, LMFT, CTS, is a Trauma Recovery Therapist at Lakeview Center, Inc., in Pensacola, Florida. She has a decade of experience in working with victims of crime-related traumatic events and their family members. She earned a master's degree in Marriage and Family Therapy from Auburn University and is licensed as a Marriage and Family Therapist in the state of Florida. She holds a second master's degree in Exercise Science and incorporates exercise interventions as an adjunct treatment for the trauma survivors with whom she works. She is also a Certified Trauma Specialist through the Association of Traumatic Stress Specialists.

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.

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

Who Should Attend:
Counselors, Social Workers, Marriage and Family Therapists, Psychologists, Nurses, Nurse Practitioners, Attorneys, Criminal Justice Personnel, Victim Advocates, Clergy, Parents

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