Live Webinar System Development Life Cycle Approach to Computer System Validation and FDA Compliance

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

"Listen from 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."

Good Documentation Practices for FDA-Regulated Computer System Validation


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 deliverables and preparing and managing them according to best industry practices is critical to validation success.
The System Development Life Cycle (SDLC) Methodology will take you through a very detailed pathway for CSV success, including all the deliverables, timing, resources, risks, and other considerations you will need to understand along the way.

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.  We will discuss all of the deliverables and best practices for accomplishing Computer System Validation (CSV) in accordance with the System Development Life Cycle (SDLC) Methodology.  We will also briefly discuss 21 CFR Part 11 compliance, FDA's guidance for electronic records and electronic signatures.

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 how to follow the SDLC methodology and complete 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
•     Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance

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 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

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