FDA Regulatory Compliance Training, Compliance Best Practices and Standards

FDA Regulatory Compliance Training Solutions

FDA regulated industries are challenged with the numerous regulations requiring FDA compliance trainings. In recent years, FDA regulated companies have been increasingly pulled up by the Agency for failing to follow regulations, especially those governing manufacturing and branding of products. Irrespective of the size of the business, FDA compliance training is essential to ensure adherence to the industry guidelines and to ensure the products do not pose any risk to the consumer or public.

Food and Drug Administration (FDA) is the U.S. Federal agency responsible for protecting public health. The scope of FDA regulatory requirements are very broad and are constantly changing, making compliance training a vital part of organization’s training needs. FDA regulates a wide range of products including food, dietary supplements, pharmaceutical drugs, vaccines, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, and veterinary products. In addition to this, FDA also has the responsibility for regulating the manufacturing and selling of tobacco products.

Over the past few years, FDA has tightened its enforcement actions. Citations for non-compliance can prove very expensive as they can result in direct and indirect penalties by the FDA actions. Failure to comply can lead to FDA Form 483s, Warning Letters, an injunction in the form a market recall or ban on importation /commercial distribution, license revocations, disqualification of clinical investigators and so on.

An increased number of 483s and warning letters demonstrates that many regulated industries have difficulty in implementing regulations and ensuring FDA compliance. Warning letters issued publicly can affect a company's stock value and can ultimately result in reduced revenues.

Overall, non-compliance and the FDA imposing penalties on a company for the regulatory violations can lead to a drop in customer confidence in the safety and efficacy of the product in question. An organization’s reputation can be badly affected by FDA enforcement actions. Consequently it is important to understand the complex FDA regulatory requirements for various regulated products and ensure compliance. FDA trainings are designed to teach employees on current regulations and guidance’s and how to adhere to them. These training program encompass a variety of subjects that range from conducting inspections to responding to 483’s or Warning Letters.

ComplianceOnline FDA Training Courses

FDA compliance is a multi-faceted and complex subject. An effective FDA training program will consider current trends and requirements, bringing you the latest updates from experienced instructors. ComplianceOnline offers FDA compliance training programs in various formats, including: live webinars, training recordings, in-person seminars, and customized organization-level in-person seminars. Led by recognized experts and industry veterans with decades of experience in regulatory affairs and compliance, our training programs will offer staff and management an interactive platform to understand and discuss current industry standards.