GxP (GLP, GCP, GMP) Computer Validation - User Requirements

Instructor: Michael Funk
Product ID: 701624
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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
Last Recorded Date: Apr-2010

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

In this GxP (GLP, GCP, and GMP) Computer Validation training you will learn strategies and tools to identify, gather, categorize, prioritize, and document for creation of a successful and robust user requirements document which is essential for successful computer system validation.

Why Should You Attend:
One of the most important deliverables in execution of a scalable, risk-based GxP computer validation project is User Requirements. When done well, the project User Requirements document is essential in creating the foundation for successful validation and implementation. When done poorly, they can result in software that does not meet business needs, software that creates an unacceptable compliance risk, a convoluted validation documentation package, and soaring costs brought on by iterative passes through the validation project.

Attend this Webinar to learn important concepts for creating a successful user requirements document to be used as the foundation for validation of a GxP computer system.

Participants of this webinar will receive valuable insights and tools to be used in the successful creation of a robust Requirements document. Information presented will include topics to be addressed when creating a User Requirements. Additionally, requirements gathering methods that can aid validation teams in identifying, categorizing, and prioritizing requirements in the pursuit of a Requirements document that will lay the foundation for a successful validation project will be presented. Examples will be discussed for projects that ran into problems that could be traced back to faulty requirements documents.

Areas Covered in the Seminar:

  • Introduction.
  • Business requirements.
  • Regulatory requirements.
  • Technical requirements.
  • User requirements.
  • Functional requirements.
  • Compliance requirements.
    • Security
    • Electronic records and signatures
    • Audit trails
    • Data retention
  • Disaster recovery.
  • Methods for gathering and prioritizing requirements.
  • 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.

Follow us :
Seminars by Ex-FDA Officials
Latin America: Regulatory Compliance Requirements for Life Science Products

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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