During the past year, the U.S. Food and Drug Administration issued over 100 new or revised regulatory guidance documents while withdrawing several others. The constantly changing regulatory compliance landscape poses major challenges for life sciences companies. The impact of these changes on day-to-day operations can be significant as each must be assessed, incorporated into standard operating procedure, and communicated to those affected. The burden of educating personnel on new or changed regulations and processes is enormous – as is documenting that individuals have received the requisite training to perform their jobs satisfactorily.
As companies look toward computer systems and other technology-based solutions to increase performance and improve quality, it is imperative to understand the regulations that govern the use of these systems and the related electronic records and signatures. Without this understanding, companies can waste time, resources, and money on compliance efforts that add little or no value. Worse, companies may not address the regulations well enough and potentially introduce unnecessary compliance risk.
How AQS Can Help
AQS' staff of compliance experts have developed a suite of training programs to help your company address regulatory compliance obligations effectively and efficiently. These comprehensive programs represent a best practices approach to regulatory compliance and can be tailored to suit a variety of audiences. Whether you require an awareness program for executives, an introductory program for managers and supervisors, or an advanced “how to” program for those responsible for performing the work, AQS will present the appropriate level of information in the proper business context. We can also create customized training programs with your company-specific information – creating a program that is specific to your unique situation.
- A Risk Based Approach to Computer System Validation
- 21 CFR Part 11
- cGMP/GLP Introductory and Departmentalized Courses