Good Documentation Practices to Support FDA Computer System Validation
OVERVIEW
This webinar will leave you with the
information needed to create and maintain good documentation that meets FDAcompliance 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.
 |
| FDA Computer System Validation |
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
 |
| FDA Compliance |
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:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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