Description
Non-Conformance and Deviation Management Course
The Non-Conformance and Deviation Management course introduces you to the elements and requirements of a compliant Non-Conformance and Deviation management system. This course aims to focus on the critical elements of the Non-Conformance and Deviation process and it’s implementation. A deviation and / or non-conformance is not something that can be left to one side, forgotten about or discreetly overlooked. In either case, to ignore such an instance could be extremely costly to you, your company and also could ultimately pose a threat to the health and safety of the patient, and unchecked/uncorrected deviations will show up during inspections and auditing.
The Course: What’s inside
The course will cover all required aspects, such as:
- Regulatory requirements
- Deviation definition
- Deviation Management
- Classification of deviations
- Impact assessment (scope, product quality and patient safety, GDP and QMS)
- Risk analysis
- Root Cause Analysis (RCA)
- The Investigation process
- CAPA (Corrective and Preventive Action)
- Effectiveness checks
Who is it for?
The Non-Conformance and Deviation Management course is intended for all staff where a Quality Management System (QMS) and Good Distribution Practice (GDP) is in place for the import/export, storage and handling of pharmaceutical goods in a compliant manner is required. It is also essential knowledge for Responsible Persons (RPs) and management staff.
Further Assistance
The requirements for Good Distribution Practice are outlined comprehensively in the European GDP Guideline (2013/C 343/01). You may also visit our Help & Support page if you require further help.
