Corrective and Preventive Action training puts out the guidelines on how exactly you carry out the corrective and preventive actions to ensure a high-quality product and clinical trials within the pharma industry.
What do you do when something goes wrong with any of your projects? You go back, find where something went wrong, and fix it. While this might seem like a straightforward approach for personal projects, the same to do for huge pharma projects and products can be a very complex and time-consuming process. It is always better to prevent than correct an error, and knowing the right way to take the proper action can save time, energy, and resources. The CAPA, which stands for Corrective and Preventive Action, is a system that puts out the guidelines on how exactly you carry out the corrective and preventive actions to ensure a high-quality product and clinical trials within the pharma industry.
Why do you need Corrective Action and Preventive Action training?
CAPA helps achieve operational excellence as it can reduce product recalls, ensure a safe environment, reduce the chances for errors and accidents, reduce repair costs and minimize your liabilities. It is also important to follow the CAPA guidelines to stay compliant as the pharma industry is considered highly safety critical.
The FDA places high importance on CAPA in all manufacturing industries, and it is mandatory to follow the CAPA processes to get approved.
What does the CAPA training constitute?
Taking the CAPA training will give you a good understanding of everything relevant to CAPA and help you establish the right process controls in your company. It will help your staff and stakeholders be aware of the technical terms involved and the right way to do things and educate them on the importance and need for adopting CAPA. Here are some of the major topics covered in detail during the training:
- The two constituting actions of CAPA
- All relevant terms
- The importance of implementing CAPA
- The protocols, requirements, and procedures to be followed for a proper CAPA implementation
- The main objectives to be achieved
- The features and important elements of the CAPA software
CAPA requirements training
This training module helps you understand the regulatory requirements that the organization must meet as part of the FDA rules. According to the FDA requirements, the manufacturer should establish the following CAPA procedures
- Process analysis and statistical methods to detect non-conformities
- Root cause investigation for all problems
- Finding the right action to be taken for the prevention and rectification of non-conformities
- Ensure the quality of the final product
- Proper documentation
- Proper flow of information across the relevant bodies
- Document review at the management level
CAPA procedures
The CAPA procedures allow you to implement an effective CAPA process and provide you with the actual steps that must be carried out as part of CAPA. The training for procedures will cover each of these steps in detail. The steps involved are:
- Identification of the non-conformity
- Evaluation of the non-conformity
- Root cause analysis
- Action plans
- Implementing the Action plan
- Verification of the implementation(VOI) and verification of effectiveness (VOE)
- Closure
CAPA objectives training
The CAPA process is supposed to meet certain mandatory objectives to get approved by the FDA. Understanding these objectives is necessary to establish the right process controls and meet the regulatory requirements. The CAPA objectives are:
- Verification of the quality system, its documentation
- Verification of the action plans’ appropriateness and root cause investigations
- Ensuring proper use of data and data correctness throughout the process. You should also ensure that the right statistical methodologies are used to evaluate quality problems.
- Confirm the correct causes for non-conformities, identify, and analyze them to be able to take a right corrective action
- Determine the Verification of Effectiveness and Verification of Implementation status of the action plans being implemented.
Training on how to fill out the CAPA template form
The CAPA template form is an important part of the CAPA process, which is used to initiate a CAPA process and includes all the relevant details filled out in the right format. Multiple versions of CAPA forms are available online, and you should be able to choose the one that best fits your company and ensure all details are filled in properly.
Training to fill out the CAPA template form will help you ensure there are no mistakes and you fully understand what the form entails. Here are the basic steps involved in filling out a CAPA template form:
- Problem identification. A brief and clear description of the problem.
- The Correction and Containment action to be taken in case of a non-conformity
- A Why-Why analysis that provides detailed root cause analysis in the form of five whys exploring the entire cause and effect relationship with relevance to a non-conformity
- Determining the exact root cause using root cause analysis along with analytical methods.
Details on the action plan implementation will be filled in on the form next. The draft of the plan must include the proper corrective and/or preventive actions that must be taken.
The final section of the form should contain information on the verification of the action plan implementation. This detail includes the details of verification of implementation and the verification of effectiveness.
This sample of CAPA is quite generic, and the CAPA form template could differ based on the purpose, product in place, and the various processes involved.
Training for CAPA terminology
There are many standard industry-specific terminologies that you must be aware of so that you can use the appropriate terms in your documents and CAPA forms. You need to have a good understanding of these terminologies to be able to submit proper document work for FDA approval. Here are some of the terms you should have a good understanding of which the training will ensure
- CAPA
- CAPA template
- GMP
- Corrective Action
- Preventive Action
- Correction
- Non-conformity
- Why-why analysis
- Verification of Implementation (VOI)
- Verification of Effectiveness (VOE)
- Action Plan
- Risk analysis
- Occurrence
- Root cause
- Correction and Containment Action
- Closure
Correcting Action and Preventive Action online training
CAPA, while essential to get compliant enough to get FDA approvals, goes beyond just compliance. It helps achieve optimal results in all your projects. It helps avoid recurrent issues and gives you a well-planned course of action in case of any issues or non-conformities. It streamlines your corrective actions and ensures your products are of high quality and you don’t spend more money on rework or recalls. This CAPA online training has been developed by Ellena J. Jefferson, a Training and Quality Advisor with ICON plc. This 2-hour training course provides you with a certificate of completion and CEU/CPD accreditation.
