Computer System Validation and Part 11 Compliance

    /Joy  /McElroyspeaker of Training Doyens
    Speaker: Joy McElroy
    Duration: 90 Minutes
    Product Code: 50108
    Level: Intermediate
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OVERVIEW

This Computer System Validation Training 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 and companies must update their systems and processes to maintain compliance.

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.

WHY SHOULD YOU ATTEND

Upon completing this course participants should:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • How to avoid 483s and Warning Letters
  • How to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • What are the requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • What are the "Right size" change control methods that allows quick and safe system evolution
  • How to minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • How to write test cases that trace to elements of risk management
  • How to protect intellectual property and keep electronic records safe

AREAS COVERED

  • 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 allows quick and safe system evolution
  • Minimizing the validation documentation to reduce costs without increasing regulatory or business risk
  • Writing test cases that trace to elements of risk management
  • Protecting intellectual property and keep electronic records safe

LEARNING OBJECTIVES

This CSV webinar will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

WHO WILL BENEFIT

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

SPEAKER

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

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