Non-conformance Process - Practitioner (PH01701)
Course Description:
This module offers an in-depth understanding of managing non-conformances in the pharmaceutical industry. It provides comprehensive guidelines on when and how to document non-conformances, the critical timelines to adhere to, and the specific roles and responsibilities involved. Additionally, it covers the essential steps for conducting thorough investigations. Ideal for professionals responsible for non-conformance management, this module equips you with the knowledge needed to effectively handle non-conformances in a pharmaceutical setting.
Learning Outcome:
This course provides an in-depth and comprehensive understanding of managing non-conformances in a GMP environment. Gain valuable insights into the complete process, from recording deviations and adhering to critical timelines, to understanding responsibilities and conducting thorough investigations. This module is perfect for professionals tasked with overseeing non-conformance management, offering practical knowledge and actionable strategies to excel in your role.
This course provides an in-depth and comprehensive understanding of managing non-conformances in a GMP environment. Gain valuable insights into the complete process, from recording deviations and adhering to critical timelines, to understanding responsibilities and conducting thorough investigations. This module is perfect for professionals tasked with overseeing non-conformance management, offering practical knowledge and actionable strategies to excel in your role.
Course Features
| Modules | : | 4 |
| Duration | : | 02:30 Hour(s) |
| Assessment | : | Self |
| Skill Level | : | Entry |
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Course Content(s)
Non-conformance Process - Practitioner (PHNC0202)
In this module you will gain a detailed understanding of the process to follow when managing non-conformances. You will learn, when and how to document non-conformances, the critical timelines to adhere to, and the roles and responsibilities involved. Additionally, you will learn the essential steps for conducting thorough investigation to find the root cause.
Raising Non-conformances (PHNC0601)
In this module you will learn the process to be followed when a non-conformance occurs and the importance of raising it on time. It also covers the importance of documentation and what should be recorded. Once a record has been created, learn how to evaluate the issue that has occurred.
Investigating Non-conformances (PHNC0701)
This module focuses on investigating non-conformances and the criteria required to initiate an investigation. You’ll learn how to determine the scope of the investigation, and how to use different approaches to conduct a successful investigation. This module also provides insight into implementing corrective and preventive actions (CAPAs) to resolve the issue and prevent its recurrence.
Closing Non-conformances (PHNC0801)
This module focuses on the importance of using a a step-by-step process to close non-conformances. It covers why it is important to close non-conformances and explains when and how to initiate the closing process. You will also learn the importance of periodic review of the non-conformance system, how to do a detailed review and understand who is in the process.
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