Pharmaceutical industry personnel need training to do their jobs effectively. In fact, many domestic and international regulations require that pharmaceutical professionals be adequately trained to do their jobs.
A good training program provides the process for ensuring all employees receive adequate, relevant, and documented training to enable them to perform their assigned functions safely and in compliance with applicable guidelines/regulations. Each company should develop and implement practical training approaches to evaluate, establish and/or provide training for FDA regulated industries. An evaluation should be made to verify all local or corporate standards are met concerning the program and outline provided.
With any training program, there are the associated training records. Records document who was trained, when they were trained, and what skills they have mastered. Training records provide documentation for regulatory agencies, information for personnel evaluations, and support for promotion or salary increases. Training documentation can range from paper files maintained in the work area to training completed, recorded, and stored in validated, electronic databases. Regardless of how training completion is documented, it should be readily accessible for FDA audits, etc. Also, it should be easy to quickly identify if individuals are qualified for the tasks and positions they are performing.
Often, skilled resources and Quality expertise are not available to understand the regulatory requirements for developing, implementing and managing a compliant and robust training program. Kymanox’s broad expertise in implementing efficient, effective, and sustainable policies, processes and procedures will ensure your GMP Training Program includes all of the necessary compliance elements to meet the satisfaction of the internal and external customers it supports and serves, along with meeting the compliance requirements and rigors of today’s regulatory environment.