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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.
Seminars
Course Descriptions
- Computer System
Validation in FDA-regulated Industries
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- 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
View the Agenda
View the Schedule
Attendee Comments
Register to Attend
- Achieving and
Maintaining 21 CFR Part 11 Compliance
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- 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
View the
Agenda
View the Schedule
Attendee Comments
Register to Attend
- Auditing Computer System Providers
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- 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
View the Agenda
View the Schedule
Attendee Comments
Register to Attend
- Computer System Validation
Overview
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- 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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View
the Agenda View the Schedule
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Attendee Comments Register to Attend
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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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View the Agenda
View the Schedule
Register to
Attend
- Certified Software Quality
Engineer (CSQE)
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- 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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View the Agenda
View the Schedule
Register to
Attend
View Current Brochure
(PDF file)
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