Best Practices in Preparation for an FDA Computer System Audit

Carolyn Troiano
Instructor:
Carolyn Troiano
Date:
Wednesday, March 10, 2021
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 503511

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$190 Recorded
$390 Corporate Recorded
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Overview:

As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.

This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity.

The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues.

The FDA contact person(s) should be able to tell the story of how each system came into Production in a validated state and how each system is maintained in that validated state with the data integrity assured.

It's important to have the right resources and understanding of the process prior to any inspection. Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance.

You will learn some tips based on real FDA inspections and lessons learned that will be shared with the audience.

Why you should Attend: FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.

This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance and enforcement that can help in preparation for an FDA inspection or audit of computer systems that are regulated. There are some key areas of focus that will be covered that will help you to plan for an on-site inspection.

Areas Covered in the Session:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • "GxP" - Good Manufacturing, Laboratory and Clinical Practices
  • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • Data Integrity and Governance
  • Data Archival to ensure security, integrity and compliance
  • Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
  • Recent FDA findings for companies in regulated industries
  • The resources, documentation and room preparation necessary to adequately prepare for inspection
  • Q&A

Who Will Benefit:
  • Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity, and computer system validation (CSV)
  • Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment


Speaker Profile
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.


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