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Langue du site : Français - English
Réf : 26366
Evènement :Best Practices in Preparation for an FDA Computer System Validation Audit

Date :Mardi 16 Janvier 2018

Lieu :Training Doyens 26468 E Walker Dr,Aurora, Colorado 80016-6104
80016-6104 Aurora, Colorado, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--




Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

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. In this FDA Compliance Training, you’ll learn all about how to prepare your system validation documentation for an FDA audit of your company’s computer systems.


It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.


  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
  • System Design Specification (SDS) that details how the functional requirements will be delivered
  • Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)
  • Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
  • System Acceptance and Release Notification
  • System Retirement steps to close out the life cycle
  • Data Archival to ensure security, integrity and compliance
  • Best Practices for preparing for an FDA computer system audit
  • Q&A


  • To understand how to prepare computer system validation documentation in preparation for an FDA audit.
  • To understand the many deliverables required to complete a computer system validation effort.
  • To understand industry best practices.
  • To understand and avoid potential pitfalls.
  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

All FDA-regulated industries:

  • Pharmaceutical
  • Biological
  • Medical Device
  • Tobacco


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

Toll Free:+1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882


PRICE :$159


Plan et itinéraire
Adresse de la conférence :
Training Doyens 26468 E Walker Dr,Aurora, Colorado 80016-6104
80016-6104 Aurora
Colorado, États-Unis
Tél : 7209961616
Plan et itinéraire


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Best Practices in Preparation for an FDA Computer System Validation Audit Pharmacie
life science, fda compliance training
50 1 --


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