Computer System Validation and Part 11 Compliance

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Feb 16, 2017
90 minutes
Product Description

Ensuring Infrastructure Qualification and Computer System Validation to Avoid FDA Form 483s and Warning Letters

Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

This Computer System Validation Training by expert speaker Joy McElroy will explore proven techniques for reducing costs associated with implementing, using and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements. This makes it necessary for the companies to update their systems and processes to maintain compliance.

This webinar will help you understand what is expected in Part 11 and Annex 11 inspections, you will learn how to avoid 483s and Warning Letters. You will also understand how to implement a computer system using risk-based validation to gain maximum productivity and reduce costs by as much as two thirds, and understand the requirements for local, SaaS, and cloud hosting.

By attending this training session, you’ll learn how to select resources and manage validation projects, and understand how to minimize the validation documentation to reduce costs without increasing regulatory or business risks. Additionally, you’ll learn how to write test cases that trace to elements of risk management and how to protect intellectual property and keep electronic records compliantly.

Session Highlights

  • Understanding what is expected in Part 11 and Annex 11 inspections
  • Avoiding 483s and Warning Letters
  • Implementing a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two-thirds
  • Requirements for local, SaaS and cloud hosting
  • How to select resources and manage validation projects
  • "Right size" change control methods that allow quick and safe system evolution
  • Minimizing the validation documentation to reduce costs without increasing regulatory/business risk

Who should attend

  • Regulatory Affairs
  • QA/ QC
  • IT/IS
  • Software Managers
  • Project Managers
  • Software vendors and suppliers

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Joy McElroy

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and...   More Info
More Events By The Speaker

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