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Change Control Management Techniques- A-Z for FDA Compliance
This seminar explains how to develop a change control plan that satisfies all parties with minimal documentation. It provides proven techniques for categorizing and processing changes so that quality is improved and overhead is reduced.
Description
It is well known that most problems related to computer systems are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the system, system owners and IT staff are faced with simultaneously making changes, performing validation, and updating documentation.
This seminar explains how to develop a change control plan that satisfies all parties with minimal documentation. It provides proven techniques for categorizing and processing changes so that quality is improved and overhead is reduced.
Areas Covered in the seminar:
- Change control for instruments, hardware, operating systems and application software.
- The change control process for planned and unplanned changes.
- How to deal with security patches.
- What to test after changes.
- How to document changes.
- How to get Quality Assurance approval of changes.
Who will benefit:
- System Owners
- IT
- QA
- Managers
Instructor Profile:
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation - Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 177 mission critical software validation projects.
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