ComplianceOnline

GxP (GLP, GCP, GMP) Computer Validation - Change Control and Periodic Review

Instructor: Michael Funk
Product ID: 701625
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This GxP (GLP, GCP, GMP) Computer Validation training will discuss on insights and tools for creating successful Change Control and Periodic Review processes in order to help ensure that a GxP computer system remains in a controlled state beginning with validation activities and extending through the life of the system.

Why Should You Attend:
Change Control and Periodic Review are the two critical concepts that are key to production of a robust computer validation package for a regulated system. These processes are important not only for successful system design and implementation so that FDA regulatory expectations for validation of computer systems are met and key functions in support of business needs are successfully delivered, but that compliance and support of business needs are maintained over the life of the system.

Attend this Webinar to learn important concepts for creating successful Change Control and Periodic Review processes in order to help ensure that a GxP computer system remains in a controlled state beginning with validation activities and extending through the life of the system. Participants of this webinar will receive valuable insights and tools to be used in the successful creation of robust Change Control and Periodic Review processes. Information presented will include topics to be addressed when creating these important deliverables.

Areas Covered in the Seminar:

  • Introduction.
  • Change control procedures.
    • Types of changes
    • Initiation/approval/implementation
  • Documentation requirements.
  • Change logs.
  • Documentation change control.
    • Periodic review procedures
    • Determining periodic review frequency
    • Review and documentation of cumulative changes to the system
    • Review and documentation of supporting processes and procedures (e.g., training, SOPs, user accounts, etc.)
    • Periodic review report
  • Pitfalls to be on the lookout for.
  • Questions and Answers

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • IT personnel supporting GxP systems
  • Validation specialists
  • Management of business units using GxP systems
  • Users of GxP systems
  • Project managers tasked with overseeing GxP system implementation projects
  • Consultants
  • Quality Assurance personnel
  • Quality System Auditors

Instructor Profile:
Michael Funk, is owner of GMF Consulting Services, L.L.C and is a GLP software quality assurance and computer validation specialist with over 15 years of experience in the pharmaceutical industry. As a Sr. Analyst and Site Lead for computer systems for a major pharmaceutical company, he was accountable to management for systems compliance and suitability for supporting business needs. His strong science background and customer focus gives him a unique perspective with regard to compliance and implementation of regulated computer systems in support of critical drug development activities.

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