Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms. "

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Description

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, tobacco and other regulated industries.
As a major part of the computer system validation effort, an FDA-regulated company must ensure that all validation documentation is prepared in accordance with the Agency’s guidelines.  Having the right documents and preparing and managing them according to best industry practices is critical to validation success.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized.

There is an enormous body of documentation and information available that can be overwhelming.  This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available for appropriate documentation of the validation process. 

Why Should You Attend

You should attend this seminar if you are responsible for planning, executing or managing the validation of a system governed by FDA regulations.  This is true whether using a "wet" or ink-based signature, or an electronic signature.  It is also true whether maintaining paper-based or electronic records.  Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.

Areas Covered

Upon completion of this session, attendees will have an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements.  They will understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs.  The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.

Who will Benefit

Professionals in the following industries may also benefit from the content:
    •   Pharmaceutical
    •   Medical Diagnostics
    •   Biotechnology
    •   Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
    •   Animal Health

Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm

   •    Information technology managers and analysts
   •    QC/QA managers and analysts
   •    Clinical data managers and scientists
   •    Compliance managers
   •    Lab managers and staff
   •    Automation analysts
   •    Computer system validation specialists
   •    GMP training specialists
   •    Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

Back to Top