ComplianceOnline

GxP (GLP, GCP, GMP) Computer Validation - Concepts and Essential Elements

Instructor: Michael Funk
Product ID: 701623
Training Level: Basic to Intermediate
  • Duration: 84 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

In this GxP (GLP, GCP, GMP) Computer Validation training you will learn successful process of GXP computer systems validation and the essential elements must be addressed and delivered for scalable and risk based computer validation project.

Why Should You Attend:
When a GxP computer system is implemented, a wide array of critical elements must be addressed in accordance with regulations for successful and compliant implementation such as planning documents, requirements documents, executed test scripts and cases, training documentation, planning and execution of change control activities, 21 CFR Part 11 compliance with regard to electronic records and electronic signatures, planning for ongoing post-implementation compliance, system compliance, periodic review, etc. All the above activities can be successfully done by following an established CSV process.

Attend this Webinar to Learn from the experience of a GLP computer validation specialist with 15 years of experience validating complex computer systems in the pharmaceutical industry.

Participants of this webinar will receive valuable insights into the computer validation process as well as tools that can be used to aid and enhance validation projects in a scalable and risk-based manner so that compliance is optimized and costs are contained. Key compliance roles will be presented as well as concepts that should be considered when creating required deliverables in support of a validation project.

Learning Objectives:

  • Learn key concepts that can help you better understand the underpinnings of GxP computer validation projects.
  • Learn a successful process that can be used to guide your validation team to success from the standpoint of both business and compliance risk and resource utilization.
  • Learn the essential elements that must be addressed and delivered when executing a scalable, risk-based GxP computer validation project that achieves compliance and maintains compliance over time while controlling costs.

Areas Covered in the Seminar:

  • Introduction.
  • Key roles in computer validation activities,
  • Key concepts to consider when validating computer systems,
  • Essential elements that must be addressed when validating GxP computer systems, including:
    • Validation planning
    • Requirements and other documentation
    • 21 CFR Part 11
    • Testing and reporting
    • Training
    • Change control
    • Continued system compliance
  • Decommissioning GxP systems.
  • 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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