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18 May through 19 May 2021 |
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Compliance Online
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Event description:
One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. A single inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.
It is therefore critically important to assure that changes are properly described, justified, assessed for risk, implemented, and documented. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.
This seminar will help all personnel involved in proposing, assessing, and implementing changes to un...
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One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. A single inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.
It is therefore critically important to assure that changes are properly described, justified, assessed for risk, implemented, and documented. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.
This seminar will help all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply Change Control best practices. Key focus will be placed on change proposals, justification / risk assessment and change execution / implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Techniques for assuring robust Change Control programs in light of COVID-19 restrictions will also be discussed.
Learning Objectives:
Upon completing this course, participants should be able to:
Understand the purpose of change control
Understand regulatory requirements and FDA expectations for change control
Identify what types of changes are /are not subject to change control
Properly describe changes
Properly justify changes
Develop a comprehensive Change Execution Plan
Conduct a proper change Risk Assessment
Ensure proper execution of changes
Ensure proper implementation of changes
Develop a complete Change Control documentation package
Utilize critical thinking skills throughout the change control process
Avoid pitfalls during the change control process
Who will Benefit:
This course is designed for people tasked with:
Authoring change proposals
Assessing / approving change proposals
Executing / implementing changes
The following personnel will benefit from the course:
Change proposal authors
Reviewers / approvers of change controls
Change control system owners
Production staff / management
Engineering staff / management
Validation staff /management
QC staff / management
Posting date:
24 March 2021 |
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