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

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

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


Join This course On April 19, 2017 at 01:00 PM EST at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This webinar on computer system validation regulated by FDA, describes the basic requirements for validating and documenting ER/ES capability in systems.

Why Should You Attend

You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. 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.

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

Areas Covered

-- Learn the requirements for documenting efforts related to systems governed by FDA
-- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
-- Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
-- Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
-- Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

Learning Objectives

Get 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
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
Get a good grasp of how to leverage these practices across all systems by creating a standardized program

Who will Benefit

-- Information Technology Analysts
-- QC/QA Managers and Analysts
-- Clinical Data Managers and Scientists
-- Analytical Chemists
-- Compliance Managers
-- Lab Managers
-- Automation Analysts
-- Computer System Validation Specialists
-- GMP Training Specialists
-- Business Stakeholders
-- Consultants in the Life Sciences Industry

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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