GxP-CC provides various training courses that specifically address the key areas of the regulated pharmaceutical and medical device industries. We are able to provide “best practice” examples in order to help our clients find the ideal solution for their company.
GxP-CC offers focused training courses on particular aspects of valid laws and regulations of interest to your particular type of business. We provide procedures to fulfill these laws and regulations in a complete and effective manner.
Our external legal department can take the legal situation into account and, together with your quality management and our specialists, provide the sound legal framework your company requires to drive a compliant business.
The validation of processes and software are central activities in a controlled environment. GxP-CC provides you with information concerning the establishment of the necessary validation procedures. Based on our internal templates, we guide you through all phases of the validation process, from the initial implementation to the finalization of the validation project.
GxP-CC works together with you to assess and reveal compliance risks and to initiate measures to mitigate them.
Risk management is a key tool focusing on all compliance activities. GxP-CC works together with you to assess and reveal compliance risks and to initiate measures to mitigate them. We offer Risk Management training that arms you with effective processes and necessary tools to support, monitor and alleviate any risk found over the lifecycle of your product.
In order to successfully complete an audit by one of your customers or by a regulatory authority, good preparation is a corner stone to success. We work closely with you to offer a variety of training courses in order to prepare your company for the eventuality of a GMP audit. We can instruct your employees and train them on successful handling of a specific audit or Audit Management in general.
Taking advantage of our training on “Corrective Action and Preventive Action” (CAPA) enables your company and employees to identify, execute, document and monitor your CAPA activities. We supply you with the necessary information on the implementation of CAPA processes using our pre-defined templates, which are modified to suit your exact needs. In the long term, your company will receive a marked and sustainable overall improvement in quality in your Quality Management System.
Our project managers will share their vast experience with you on how to manage a project in a controlled environment. The GxP-CC project managers will coach and train your “in-house” teams by providing you with information concerning project setup. This enables your company to manage the validation aspects as an integral part of your project management. We furnish you with key performance indicators to help you measure your success in terms of budget, time and quality.