Webinar: Computer System Validation

Computer System Validation

Date: Every 2nd and 4th Thursday
Time: 1:00 PM EST | 10:00 AM PST
Duration: 90 Min + Q
Price: $375.00

Webinar Description

With the ever increasing dependency on computerized systems and the rapid grown in the ever changing technology advancements in computerized systems, it becomes even more important to ensure that compliance standards in this regulated industry are implemented and maintained.  Doing so, is the challenge.

The quality of electronic systems for manufacturing, laboratory and clinical use is carefully regulated and there is a need to gain a greater understanding of what if required by the FDA.

This course is designed to assist firms to identify the validation requirements for quality critical and business critical applications and computerized systems while reducing costs through proper risk analysis techniques and the implementation of templates for standards.

This 75 minute webinar will focus on the minimum requirements for proving validation compliance standards for many of the applications and computerized systems utilized in the regulated industry and to develop practical solutions for integrating the quality assurance of computerized systems and electronic data into everyday business operations.

This course will address in detail the process for successfully managing, gathering, analyzing, specifying and documenting validation and for implementing the 21 CFR 11 regulations, which affects all aspects of computerized systems used in the pharmaceutical industry. 

All attendees will receive:
  • Course presentation
  • Certification of Attendance from GXP Conferences

Webinar Objectives

• Regulatory Requirements (FDA and EU)
• Perspective from the FDA: 21 CFR Part 11 Compliance and Computer Validation
• Risk Analysis - Determine Which Systems Need to be Validated
• Software Validation Requirements for:
• Spreadsheets
• Production Equipment
• Lab Equipment
• Data Migration
• User Requirement Specifications (URS)
• Design Specifications
• Compiling the Validation Master Plan (VMP)
• Qualification Requirements (IQ,OQ, PQ)
• Preparing Validation Summary Reports
• Requirements for Off the Shelf (OTS) Software
• Validation Planning and Project Management
• Effective Software Testing
• Auditing GxP Computer Systems
• Auditing Software Vendors
• Assessing the Impact of Software Changes
• Q

Who Should Attend

• Information Technology
• Quality Assurance
• Quality Control
• Laboratory Staff
• Managers
• GMP, GCP, GLP Professionals
• Regulatory Affairs
• Trainers

Please forward to collegues and appropriate departments.

GxP Conferences and eLearning
PO Box 335
Medford, NJ 08055
t. (609) 859-3455
f. (856) 810-7339

Register on these dates for this event:
1:00PM EST - 10AM PST
1:00PM EST - 10AM PST
1:00 EST - 10AM PST
1:00PM EST - 10AM PST

   Instructor Profile
John Cuspilich
John has enjoyed over 26 years of hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries world wide.

Serving within various business units within Quality Assurance / Regulatory Affairs, Training and Development, Manufacturing, Research, Engineering, Technical Mechanical Departments, etc.., John has assisted many companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ issues or ‘due-diligence’ initiatives.

Assisting companies to achieve, resolve, remediate and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.

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About GxP Conferences
GxP Compliances is an emerging leader in pre-market and post-market conformity and compliance online webinars tailored to meet the needs of those in a wide variety of regulated industries. Utilizing our innovative, technologically-advanced tools individuals have exclusive access to exceptional cutting-edge live series and individual training modules providing in-depth information related to conformity and compliance. Our unique online conferences have been created with the utmost in quality, with compliance and conformity in the forefront of all of our presentations.
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1:00PM EST - 10AM PST