Date: | December 12, 2017 - 1:00pm - 2:30pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | Training Doyens 26468 E Walker Dr, Aurora, CO, 80016-6104, United States |
Website for Event: | http://bit.ly/2zMmmfh |
Topic: | Health Education |
Description: | OVERVIEW This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards. You will learn about what must be done to ensure the system remains in a validated state. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, and GCP) related products be validated and maintained in accordance with specific rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology. WHY SHOULD YOU ATTEND This FDA Compliance training 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. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures 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. The importance of the sequence of steps will also be covered. AREAS COVERED • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology LEARNING OBJECTIVES • To understand how to create, revise and maintain documentation that is FDA-regulated. WHO WILL BENEFIT • Information Technology Analysts All FDA-regulated industries: • Pharmaceutical SPEAKER Carolyn Troiano has more than 30 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. For more details click on this link: Email: support@trainingdoyens.com PRICE :$199 |
Contact Name: | Training Doyens |
Contact Email: | support@trainingdoyens.com |
Contact Phone: | 7209961616 |