This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. 'Failure to employ effective CAPA systems can lead to FDA Warning Letters and worse. Accurate documentation is a must - but capturing information from a diverse workforce can be very difficult. Do you have what it takes to meet these challenges?'.
Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage - the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.
Accurate and thorough documentation and a process for conducting investigations is critical in an FDA-regulated environment. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds.
This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations. It integrates FDA requirements and guidelines while focusing on effective documentation, data collection, and understandable language necessary for successful investigations. This training is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems - such as engineers, investigators, laboratory QA, manufacturing supervisors and technicians.
Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage - the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.
Accurate and thorough documentation and a process for conducting investigations is critical in an FDA-regulated environment. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds.
This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations. It integrates FDA requirements and guidelines while focusing on effective documentation, data collection, and understandable language necessary for successful investigations. This training is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems - such as engineers, investigators, laboratory QA, manufacturing supervisors and technicians.
Areas Covered in the seminar:
- Effectively expedite investigations.
- Document investigations appropriately for the intended audience.
- Assure that all necessary data/information is collected and documented.
- Overlay the FDA’s requirements and expectations related to conducting and documenting investigations.
- Construct an effective report.
- Attain a thorough understanding of the FDA’s requirements and expectations related to conducting and documenting investigations.
- Prepare clear, concise and effective documentation of investigations.
- Improve communication and teamwork.
Who Will Benefit:
This course is appropriate for all who are regularly called upon to resolve problems, or whose input would aid in preventing problems.- Engineers
- Investigators
- Laboratory QA
- Manufacturing Supervisors
- Technicians
Course Provider
Nathan Conover,
