There have been several form 483s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to Corrective Action and Preventative Action programs (CAPA).
Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, complete and must provide enough details within the CAPA procedures to ensure an effective CAPA investigational procedure.
All failure, deviation or out of specification investigations must be adequately documented, corrected, prevented, and checked for corrective action effectiveness through the use of a compliant CAPA investigational system and program. The result of a product investigation impacts the quality of the cGMP manufactured product label claim, to avoid it from being termed ‘adulterated” by the FDA which may result in product recalls, complaint, and further actions by the FDA.
In this introductory training, we will discuss and highlight to GMP professionals the importance of writing effective CAPAs from initiation, implementation, closure, effectiveness and follow-up. It will be a great resource for professionals to build and strengthen their CAPA Management program into a proactive and preventive system for Quality Management Systems. Additionally, key case examples will aid personnel in identifying the most effective means to continuously develop effective CAPAs for an enhanced and more robust program.
Upon completion of this course, you will be able to:
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This entry level training will provide a great resource to Medical Device, Pharmaceutical, and Biologics Industries personnel within the following departments:
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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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