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Good Documentation Practices to Support FDA Computer System Validation


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Who should attend?

Information Technology Analysts QC/QA Managers QC/QA Analysts Clinical Data Managers Clinical Data Scientists Analytical Chemists Compliance Managers Laboratory Managers Automation Analysts Computer System Validation Specialists GMP Training Specialists

Details

OVERVIEW

This webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards.  You will learn about what must be done and what must not be done.  In addition, you’ll learn about the various computer system validation deliverables and how to document them.

FDA requires that all documentation related to GxP products (GMP, GLC, and GCP) be created and maintained in accordance with specific rules.  From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation.

WHY SHOULD YOU ATTEND

You should attend this FDA regulatory compliance training if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit.  You will also benefit from learning about the guidelines for computer system validation and the many deliverable documents that need to be produced in a way that is FDA-compliant.  Having completed this course, you will be on your way to successful future FDA audits and inspections.

AREAS COVERED

  • FDA Good Documentation Practices
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • GAMPV System Categorization
  • Industry Best Practices
  • Potential Pitfalls

WHO WILL BENEFIT

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • 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

LEARNING OBJECTIVES

  • To understand how to create, revise and maintain documentation that is FDA-regulated.
  • To understand the many deliverables required to complete a computer system validation effort.
  • To understand industry best practices.
  • To understand and avoid potential pitfalls.

 

For more detail please click on this below link:

https://goo.gl/NCV7DV

 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Prices

Live Session $199 for one participant Corporate Live Session $549 Group – Max 10 Participants from one location. Recorded Session $219 Get unlimited access to audio recording of the webinar for 6 months. Training CD $399 MP3 files, PDF presentation and reference manual will be delivered on a CD Super Combo Offer 1 $329 Live and Recorded webinar Super Combo Offer 2 $499 Live and Training CD

Contact

Training Doyens
support@trainingdoyens.com

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