ComplianceOnline

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

Instructor: Michael Funk
Product ID: 701624
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

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 :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading