FDA’s 21 CFR §820.25(b): “Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.” ISO 13485:2003, 6.2.2: “The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, …” There is no getting around it – training is a requirement of your Quality System. If your company does not have in-house training personnel, you need to find another way to provide quality systems training to your employees. One option is to send your employees to seminars; however, most seminars only cover certain aspects of the FDA Quality System Regulations and/or ISO 13485 Standard. It can also be very costly to send all of your employees to various seminars; not only considering the actual dollars spent, but also considering the loss of production time for your business while your employees are traveling to these seminars. Lastly, training seminars typically cover very broad and generic topics, which therefore fail to address how to apply the FDA Regulations and/or ISO Standard to your specific business. When Regulatory Insight assists with your company’s Quality System training, you can customize the type and amount of quality systems training as needed for your employees. We will consider the audience (i.e., your company’s product line and type of operations, along with your employee’s job functions within your organization), and tailor the training to fit only your specific needs. In this way, your employees will be trained specifically on how to apply the requirements of the FDA Quality System Regulations and ISO 13485 Standard as are pertinent to your company, its products and each employee’s specific job function.