Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on October 06 for a discussion of the webinar 

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, 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.

Why should you attend

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.

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.

Webinar Takeaway

  • Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • 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
  • Learn about recent trends in technology that need to be addressed in the CSV approach
  • Q&A

Can't Make this LIVE Webinar?

Simply select the Recorded option when registering and we will send you the link to view the recorded version.

Who will benefit

Professionals in the following industries may also benefit from the content:

  • Pharmaceutical
  • Medical Device
  • Biotechnology
  • Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
  • 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
  • Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc.)

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.

Faculty Carolyn Troiano

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.

Choose a Purchase Options



$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.


$399

Live + Recorded Access

You get one log-in for the live & recorded 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email