Change is inevitable. That is why the concept of change control is critical, especially for pharmaceutical companies in FDA and EU-regulated environments, where inappropriate or “uncontrolled” changes could affect the safety of products and directly impact public health and safety.

Manufacturers realize that an effective change control process is key not only to compliance, but also to continuous quality improvement. It can lead to increased customer satisfaction and prevent product recalls and regulatory violations. It includes discussion of:

• Definition of change control in the context of FDA and ISO environments.
• Specific FDA requirements and ISO standards pertaining to change control.
• Elements of a typical change control process.
• Common problems pertaining to change control — and solutions for optimizing the process.

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