fda-compliance-computer-system

FDA Compliance Computer System

Pre Recorded

  • 90 minutes

Overview of FDA computer system validation requirements, including 21 CFR Part 11 compliance

FDA requires that all computer systems that handle data regulated by the Agency to 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 technology 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 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.

In this webinar expert speaker Carolyn Troiano will provide some insight into current trends in compliance and enforcement and cover the key aspects of complying with FDA requirements in both validating systems and maintaining them in a validated state throughout their entire life cycle.


Session Highlights:

  • Provide an overview of FDA computer system validation requirements, including 21 CFR Part 11 compliance.

  • Provide an overview of recent trends in FDA compliance and enforcement relative to computer system validation, including citations.

  • Provide a set of best practices and industry standards to meet FDA compliance requirements for computer system validation.


Why You Should Attend:

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.


Who Should Attend:

  • Pharmaceutical

  • Medical Device

  • Information Technology Analysts

  • QC/QA Managers

  • QC/QA Analysts

  • Clinical Data Managers/Scientists

  • Compliance Managers

  • Laboratory Managers

  • Manufacturing Managers/Supervisor

  • 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


Ask your question directly from our expert during the Q&A session following the live event.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

No Reviews Found

Want to attend in a Group? Call 844-810-1151 and Save upto 50%

  • $259.00

  • $164.00

  • $164.00

  • $99.00

  • Total : $00.00

Share this course with a friend
           

We Also Recommend

Food Safety and Pharmaceuticals

Medical Device Change Control and FDA Submissions

Pre Recorded
CAROLYN TROIANO
(Speaker)
Duration:
90 minutes

Food Safety and Pharmaceuticals

Potential Impacts of Alex Azar as Head of HHS

Pre Recorded
NORMA SKOLNIK
(Speaker)
Duration:
60 minutes

Food Safety and Pharmaceuticals

Transportation Food Safety Standards for Shippers, Carriers and...

Pre Recorded
JOHN RYAN
(Speaker)
Duration:
60 minutes

Newsletter

Get Notified about News, Webinars, Community & More