Developing a Strategic Approach to FDA Compliance for Computer Systems

Instructor: Carolyn Troiano
Product ID: 706124
Training Level: Intermediate
  • 31
  • July 2019
    Wednesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. We will focus on how to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do and ensure that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project, along with the importance of the sequence of steps and deliverables.

Live Online Training
July 31, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$429.00

Live + Training CD/USB

$529.00

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Read Frequently Asked Questions

Why Should You Attend:

It’s always challenging to optimize the approach to validating an FDA-regulated system and maintaining it in a state of compliance throughout its life cycle. The initial validation process can be streamlined by adequately planning all aspects of the effort. There are specific strategies and practices that can ensure the system is thoroughly and adequately designed, developed, implemented, tested and ready for production while avoiding the many potential pitfalls often encountered during the process. There are many examples of both the best practices and potential pitfalls that will be shared to ready you for your journey in FDA 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, you will learn how to do your due diligence in computer system validation by applying industry best practices and avoiding the potential pitfalls encountered by many. You will also learn how to manage these over the longer-term maintenance of a system, ensuring compliance with FDA throughout the system’s entire life cycle.

A set of strategic and tactical tips and approaches can help ensure that your validation efforts are not only compliant with FDA requirements, but will minimize the one-time and ongoing cost of validation.

Learning Objectives:

  • Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
  • Learn how to leverage GAMP 5 and the risk assessment approach to validate your systems in a streamlined manner
  • Learn how to leverage past validation efforts to optimize results
  • Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome
  • Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay
  • Learn how to keep on top of changes to the system over time to ensure it is maintained in a validated state and does not require a complete revalidation due to neglect
  • Learn how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business
  • Learn how to evaluate business processes to ensure that these are optimized as the system is being developed and/or configured to enable improvements in efficiency and effectiveness of operations that will save money in the longer run
  • Learn how to document all validation work in order to ensure that revisits to the deliverables during subsequent system changes are efficient and do not require extra labor to dig through poorly documented information
  • Learn about potential pitfalls to the validation process through real industry examples
  • Learn how to avoid and/or mitigate potential pitfalls during the validation process

Areas Covered in the Webinar:

  • Industry best practices related to compliance and computer system validation
  • Strategies for reducing the cost and complexity of compliance with FDA regulations
  • Understanding how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, thus minimizing both
  • Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
  • Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
  • Understand some of the key “pitfalls” to avoid when applying the SDLC methodology

Who Will Benefit:

Personnel in the following roles from industries such as Pharmaceutical, Medical Device, Biologicals, Tobacco, E-Liquid/Vapor, E-Cigarette, Cigar, Contract Research Organizations (CROs) will benefit:

  • 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
Instructor Profile:
Carolyn Troiano

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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