Change Control Management – From Design to Commercialization
Overview:
There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/systems specifications in addition to the more formal change control after the qualification of these systems.
The Engineering change control process will apply through design, construction and qualification up to the point that the system is considered installed/operational. The new Quality Systems guideline from the FDA states that the Quality function must be involved in the review of the design and subsequent changes to the design of facilities, equipment and systems that may impact the product quality. The question is - how much involvement is really necessary from all functional groups including the Quality group?
The course will include instructions on how to:
- Develop an Engineering Change Control system for design, construction projects and the elements of a formal Change Control system after commercialization
- Apply change control concepts while making it a practical but effective process
- Determine which equipment/systems require some level of change control after the approval of specifications and which systems do not require a formal level of change control during these stages of a project
- Understand the documentation requirements, approvals and responsible resource for conducting change control at these phases and after commercialization
Why you should attend: Most pharmaceutical companies focuses on change control management after commercialization but changes must be managed earlier during the design of facilities, equipment and systems in addition to changes implemented during the development of the manufacturing processes. The question is: What is the level of control required at the design/development stages? Who needs to be involved? What are the steps required for the processing of such changes and the documentation that is required to provide evidence of such controls?
Areas Covered in the Session:
- Specifications Change Control
- Handling of changes to URS, FRS, Design Specifications
- When do we implement some level of Change control
- Design Change Control
- Relationship between Design Qualification/Review and Change Control
- Adequate/Practical Documentation Requirements for changes during design – handling of drawings
- Functions to be involved and level of involvement
- Change Control during Construction, Start-Up and Commissioning
- Handling of Revisions to Design, Drawings and Specifications
- Changes to Construction Reports/Documentation
- Change Control Management during Qualification
- Formal Change Control Management after Equipment/Systems Qualification
- Standards/Regulations/Guidelines applicable to Change Control and Training Requirements
- Learn the characteristics of an adequate/effective procedure and documentation form and how to deliver this message during training:
- Definitions – Like for Like, Emergency/Unplanned vs. Normal/Planned Changes
- Applications for Documentation Changes
- Applications for Process Changes
- Applications for Changes in equipment/systems
Who Will Benefit:
- Personnel in Manufacturing
- Engineering
- Quality
- Validations
- Purchasing at all levels of management