Trends In FDA Compliance And Enforcement For Regulated Systems

Trends In FDA Compliance And Enforcement For Regulated Systems

  CAROLYN TROIANO

  Independent Consultant

  When : Thursday, September 16, 2021

  Time : 03 : 00 PM EST

  Duration : 90 Minutes

  Product ID : CARO-0046

  Level : Intermediate

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Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid, and other FDA-regulated industries. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

FDA requires that all computer systems used to produce, manage, and report on “GxP” (GMP, GLC, and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. 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.

Areas Covered

  • Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Learn about the importance of doing a risk assessment of all FDA-regulated systems
  • Learn about the importance of categorizing your FDA-regulated software according to GAMP 5 guidelines
  • Understand “GxP” Systems
  • Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • Learn how Data Archival plays a key role in ensuring security, integrity, and compliance
  • Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
  • Learn about recent FDA findings for companies in regulated industries, specifically related to computer systems, validation, 21 CFR Part 11, and data integrity
  • Understand the latest guidance from the FDA on data integrity
  • Learn about recent trends in technology that need to be addressed in the CSV approach
  • Learn about industry best practices for becoming inspection ready
  • Q&A

Course Level - Intermediate

Who Should Attend

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Why Should You Attend

FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technological changes that have taken place. The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals.  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 the industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to the industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Topic Background

Since 1983, with the issuance of the guidance document from the FDA on validation of computerized systems, this topic has applied to pharmaceutical products and the computer systems used to generate, collect, analyze, process, and report data. Subsequently, the FDA applied the same guidance to computer systems used in the biologics and medical device industries. More recently, the FDA has brought tobacco products under their regulatory jurisdiction and has applied guidelines for the validation of computer systems used in the manufacture, testing, or tracking of tobacco-related products. This includes cigarettes, cigars, e-cigarettes, and other forms of smokeless tobacco, such as “pouch” products.

There are specific requirements for the execution and documentation of the computer system validation process, particularly the requirements and testing components. It is crucial that you build a solid program that can be defended during an FDA audit or inspection. There are also policies needed to support these efforts. FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technological changes that have taken place.

The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. 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 the industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to the industry that was initially preventing companies from embracing the technology. This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

  • $179.00


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