All FDA Regulated Industry
FDA and Management Responsibility for Social Media Use
The use or participation in social media can lead to some surprising outcomes with the FDA. The sweeping statutory definition of “labeling” covers the use of information that appears in social media. There are several platforms that can present information either by you or a third-party, all of which can become an action by the FDA against the management’s actions or inactions. Firms should develop and impl..
FDA Compliance and Clinical Trial Computer System Validation
The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.” Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system valida..
FDA Compliance and GAMP V Computer System Classification
We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP V. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that you do not go beyond what is required for a specific classification of the system so as to be cost-effective...
FDA Compliance and Mobile Applications
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through r..
FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.You should attend this webinar..
FDA Import Program with COVID-19
Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to ..
FDA Inspections: Prepare and Survive
FDA conducts establishment inspections to determine a firm’s conformance to applicable regulatory requirements. Inspections vary based on the type of product you make or plan to make. FDA prioritizes domestic and foreign inspection assignments based on three factors. However, with the current public health crisis with COVID-19, FDA is overwhelmed with work at this time, so it will likely rely on new approac..
FDA Meeting Requests , Preparation and Conduct
The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tends to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, the clinical hold, or ..
FDA Regulation of Artificial Intelligence/Machine Learning
AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the ..
FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information, you will be able to develop meaningful CAPAs that have a chance to remedy these proble..
FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..
FDA’s and U.S. Custom’s Import Entry Program
The webinar address the critical elements of information required to present a product for entry into the U.S. We will cover what information for FDA is mandatory. You must use the new software program, Automated Commercial Environment (ACE), you need to decide on who will do that, establish operational procedures and what to do if your entry is detained. The course will explain how you can make your ..
FDA’s Cloud Compliance and Regulations
The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, archit..
FDA’s GMP expectations for Phase I & First-IN-Man Clinical Trials
This Webinar will provide details on GMP requirements throughout all phases of development and commercialization.Following Good Manufacturing Practices (GMPs) is a mandatory legal requirement from clinical studies through-out marketing. Early clinical trials are conducted to establish the initial safety of a drug. The studies are generally in a small number of healthy subjects and use lower doses of the dru..
FDA’s Scrutiny of Social Media and Corporate Responsibility
Off-label promotion falls within the scope of labeling requirements as defined by the Federal Food, Drug, and Cosmetic Act, as amended (FDCA). FDA’s application of labeling requirements to the information posted in social media of any type creates a new field of enforcement opportunity, one that may catch you by surprise. If off-label statements, whether express or implied, end up directly or indirect..