Organizational Change Management Practices for FDA-Regulated Computer Systems

Posted By : User Ref No: WURUR54461 0
  • Image
  • TypeWebinar
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  • Location 2035 Sunset Lake, RoadSuite B-2, Newark,Delaware,United States
  • Price
  • Date 28-02-2020
Organizational Change Management Practices for FDA-Regulated Computer Systems, 2035 Sunset Lake, RoadSuite B-2, Newark,Delaware,United States
Webinar Title
Organizational Change Management Practices for FDA-Regulated Computer Systems
Event Type
Webinar
Webinar Date
28-02-2020
Last Date for Applying
28-02-2020
Location
2035 Sunset Lake, RoadSuite B-2, Newark,Delaware,United States
Organize and Presented By
247compliance.us
Sponsored By
247compliance.us
Organizing/Related Departments
247compliance.us
Organization Type
Event Organizing Company
WebinarCategory
Non Technical
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Food Processing

OTHERS

Location
2035 Sunset Lake, RoadSuite B-2, Newark,Delaware,United States
  • OVERVIEW

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how organizational change should be managed.

There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective techniques and tools available to assure compliance.

 

  • LEARNING OBJECTIVES

The attendee will learn how to develop a standard approach to managing organizational change when users not only have to accept new processes, workflows and systems, but have to do so in a manner that complies with FDA guidelines for computer systems. In some cases, users will be new to the concept of validation and FDA regulation, and will have to be coached on how to follow the necessary procedures. This is true in the Tobacco industry, where regulations are emerging, but it is also true in pharmaceutical and related industries where IT staffing may not have the skills or training required. It's important to look at what is going to change, what are some of the threats and challenges, and what methods you can use to mitigate these.

 

  • WHY SHOULD YOU ATTEND

There are specific guidelines and best practices for creating organizational change as it relates to computer systems regulated by FDA.  These include, but are not limited to system implementation, testing, validation, migration, integration, upgrade and retirement.

The course will focus on the key aspects of organizational change management, including best practices and principles for handling this key component of project work in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity).  The material will include the various aspects of change management, including planning, execution, assessment and feedback.  The result will be a prescriptive approach to helping teams and individuals reach a higher level of acceptance to change.

 

  • WHO WILL BENEFIT?
  • Information technology analysts
  • QC/QA managers and analysts
  • Clinical data managers and scientists
  • Analytical chemists
  • Compliance managers
  • Lab managers,
  • Automation analysts

 

  • SPEAKER

 

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device, and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

 

For more detail please click on this below link:
http://bit.ly/39PsrJv
Email: [email protected]
Tel: +1-(510)-868-1040

 

Others Details

For more detail please click on this below link: http://bit.ly/39PsrJv Email: [email protected] Tel: +1-(510)-868-1040

Registration Fees
Available
Registration Fees Details
Live session for 1 participant Increase Participants $199 Live + Recorded Session Get unlimited access to the link for one participant, from the date of webinar completion. $269 Live + Transcript Get unlimited access to the link for one participant, from the date of webinar completion. $249 Live + Training CD Free shipment within 3 to 5 Days from the date of webinar completion. $450 On Demand Options
Registration Ways
Email
Phone
Website
Other
Address/Venue
  2035 Sunset Lake, RoadSuite B-2, Newark, Delaware - 19702 USA  Pin/Zip Code : 19702
Official Email ID
Contact
   +1-(510)-868-1040