In this webinar, we will examine the process of evaluating and completing an impact assessment when applied to change control. We will discuss how to determine the level of impact assessment needed for what type of changes and how to base this decision on risk. A major part of the discussion will be the development of tools that can be used to do a complete impact assessment and how this will lead to a change plan to complete any activities needed to fully verify/validate the change. We will also be discussing a tool for doing a change-specific risk assessment which highlights the risks associated with the change. Applicable regulatory guidance will also be discussed.
WHY SHOULD YOU ATTEND?
Control of changes is critical in a regulated industry such as pharma or medical devices. Improper, incomplete, or missing impact assessments of changes can lead to the production of a product which is unfit for market or the inability to produce good product at all. By controlling changes and doing a proper assessment of the impact of the change, including a complete risk analysis, undesirable effects of changes can be avoided.
LEARNING OBJECTIVES
- Change and the drivers of change
- Regulatory guidance or lack of guidance
- Elements of a change description
- Classification of changes: Minor changes and Everything else
- Change impact assessments
- Justification for why the change can be made
- Strategies for doing complete impact assessments
WHO WILL BENEFIT?
- Professionals in quality assurance, regulatory affairs, technical, R&D, and manufacturing working in the pharma or medical device industries.
Control of changes is critical in a regulated industry such as pharma or medical devices. Improper, incomplete, or missing impact assessments of changes can lead to the production of a product which is unfit for market or the inability to produce good product at all. By controlling changes and doing a proper assessment of the impact of the change, including a complete risk analysis, undesirable effects of changes can be avoided.
- Change and the drivers of change
- Regulatory guidance or lack of guidance
- Elements of a change description
- Classification of changes: Minor changes and Everything else
- Change impact assessments
- Justification for why the change can be made
- Strategies for doing complete impact assessments
- Professionals in quality assurance, regulatory affairs, technical, R&D, and manufacturing working in the pharma or medical device industries.
