Practical Approach to Managing Deviations

Aims
To provide an introduction on managing deviations for regulated industries. This includes the application of strategies and steps involved, as well as documentation and reporting.

Outline Syllabus

• Essential steps and investigation strategies in managing deviations
• Classify deviations based on risk to compliance and product integrity
• Assess whether a deviation warrants escalation to CAPA
• Documentation and reporting

Course Description
The course is designed to service a wide range of participants from various disciplines within the regulated industries. It provides participants with current approaches to effective deviation management, including documentation and reporting.

The course consists of a lively mix of presentations, group exercises, and discussions. Copies of all presentation slides and handouts will be provided.

Who Should Attend
The course is designed to service a wide range of participants from various disciplines within the regulated industries. Participants considering working in these sectors or those wishing to enhance their professional development and advancement in management are particularly encouraged to apply.

Learning Objectives
On successful completion of this module, the student will be able to:

• State the key reasons for deviations and failures
• Apply structured methods for managing deviations
• Document deviations in a compliant way
• Understand the relationship between deviations and CAPA
• Understand simple RCA techniques

Register your interest