Our
Computer System Validation
Training
Sessions are offered
throughout the year at conveniently located hotels. In addition
to the public classes, all of our seminars can be brought
on-site to your location.
Course
Descriptions
Computer System Validation in FDA-regulated Industries
This 2-day seminar includes an overview of
validation tasks required by FDA Regulations and Guidelines. The
course content goes beyond simply "what" needs to be done - the
emphasis is on "how" to accomplish computer system validation
tasks. The workshop format promotes hand-on, practical learning.
Participants learn:
A Validation Process that addresses Regulatory
Requirements and Guidelines for Computer System
Validation
Regulatory action taken for non-compliance to Validation
Requirements (483s & Warning Letters)
Risk Management Activities
How to develop and execute a Validation Plan
How to perform and document Validation Tasks
How to assess Software Development Activities for various
types of software, and the impact of the development
activities on the validation process
How to develop, complete, and document Test Activities
How to summarize, assemble, package, and maintain
Validation Documentation
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Achieving and Maintaining 21
CFR Part 11 Compliance
This 1-day seminar reviews the requirements,
FDA guidance and industry positions on the Electronic Records &
Electronic Signatures rule. The seminar addresses enabling
technologies and mechanisms to ensure that the system remains
compliant throughout its lifetime. Participants learn how to:
Evaluate new and existing systems for compliance
Complete a Gap Analysis
Prepare a Remediation Plan
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Auditing Computer System
Providers
This 1-day seminar focuses on the activities
associated with planning and completing audits of computerized
system providers. The session addresses evaluating the quality
of validation deliverables, and is applicable to both internally
developed and vendor supplied systems.
Participants learn how to:
Develop an Audit Checklist
Evaluate SOPs governing System Development, Maintenance,
and Support
Evaluate System Development Deliverables in relation to
SOPs and Industry Standards
Prepare an Audit Report and address Corrective Action
Follow-up
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Computer System Validation Overview
This 1/2-day introductory seminar overviews the regulatory and
business requirements for computer system validation in
FDA-regulated industries. It includes a discussion of the issues
surrounding computer system validation, and reviews the scope of
required validation activities. Recent updates to existing
regulations, and new FDA regulations and guidelines, are also
discussed.
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Risk Management Applied to
Computer System Validation
This 1-day seminar reviews the FDA regulations
and industry guidance on risk assessment including GAMP, NIST,
and ISO. The seminar addresses the process to complete Risk
Assessment and Risk Mitigation activities as applied to computer
system validation. Participants learn how to:
Identify risks as part of the validation
planning process
Develop mitigation strategies
Evaluate residual risk
Prepare a Risk Assessment Report and address
on-going risk
management
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Certified Software Quality
Engineer (CSQE)
This 2-day seminar reviews the Body of Knowledge for the
American Society for Quality (ASQ) Certified Software Quality
Engineer (CSQE). The course provides an overview in the basic
principles and application of software quality concepts, and a
refresher for individuals planning to take the ASQ CSQE exam.
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