Deviations Management Advanced
Course Description:
What happens when processes cannot be followed as per written procedures for one reason or another? Deviations can occur anywhere in the manufacturing process and it is a GMP requirement that these are raised, recorded and resolved in a systematic manner. The is course will take you through from understanding what deviations are to the process followed to raise, record, resolve and track how they are managed. It details the roles and responsibilities of the different departments involved in managing Deviations.
Learning Outcome:
- Define deviation and state the different types of deviations
- Identify the importance of raising a deviation
- Explain the deviation process;
- Categorise the deviations into different types;
- Describe the root cause analysis process.
- Explain what a deviation management system is and why it is required;
- Discuss the responsibilities of personnel for a deviation management system;
- Describe the deviation close-out process;
- Explain the importance of communication in a deviation management;
- Explain the importance of trending and management responsibilities in a deviation management.
- Define deviation and state the different types of deviations
- Identify the importance of raising a deviation
- Explain the deviation process;
- Categorise the deviations into different types;
- Describe the root cause analysis process.
- Explain what a deviation management system is and why it is required;
- Discuss the responsibilities of personnel for a deviation management system;
- Describe the deviation close-out process;
- Explain the importance of communication in a deviation management;
- Explain the importance of trending and management responsibilities in a deviation management.
Course Features
Modules | : | 0 |
Duration | : | 3 Hour(s) |
Language | : | English |
Assessment | : | Self |
Skill Level | : | Entry |