INVESTIGATION AND CAPA SUPPORT
Root causes identification and effective corrective and preventive actions is a critical expectation of the FDA and other regulatory agencies worldwide. Indeed, this area represents one of the most frequently cited problems during regulatory inspections. As an example, almost 90% of medical device’s warning letters issued by U.S. FDA include CAPA citations. Weak investigations and ineffective CAPAs are at the center of most regulatory enforcement actions.
Requirements for compliant deviation and CAPA systems are well established by regulatory agencies. Each organization must conduct focused investigations, identify true root causes, and implement effective corrective action and preventive action in a timely manner, including measuring their effectiveness.
BEC has provided investigations and CAPA system support since 2005 to major pharmaceutical, medical device, and food companies located worldwide. Among the services that our company can provide are:
TRAINING – To improve the capability of your personnel to make better investigations and to implement effective corrective and preventive actions. We have different courses and certifications that can be tailored to your specific needs. Our trainings explore the deviation and CAPA processes and best practices for both. Your participants learn how to avoid pitfalls and minimize regulatory scrutiny by having thorough investigations and a robust and a compliant deviation/CAPA system. Among our courses are:
- Four-day Investigator and CAPA Expert Certification for investigators, CAPA owners and approvers
- One-day CAPA System Management Overview for managers and directors
TEMPORARY SUPPORT – We can assist your company with temporary expert support to:
- Reduce backlog of laboratory, production or customer complaint investigations
- Fix and enhance your deviation/CAPA system. Our expert resources will design a compliant and sustainable deviation/NCR and CAPA system. After all, we wrote the best-selling book in this topic.
MONITOR – BEC can provide your company with affordable ways to monitor the effectiveness of your deviation/CAPA system. Our service of independent reviews of deviation and CAPA documents will provide you peace of mind about this critical system. Dozens of companies that went through a CAPA warning letter hired us to provide an independent verification of their deviations and CAPA documents.
OUTSOURCING – Our company offers full outsourcing possibilities for the above mentioned activities related to deviation and CAPA system activities.