FDA Good Clinical Practice Regulatory Compliance Training - Live Webinars, Recordings & CDs

This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.

This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study.

This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations.

This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements.

This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.

This comprehensive study of the clinical supply process will address increasing efficiency in packaging and labeling. It will also detail compliance requirements that have to be met in the process. Participants will enjoy the opportunity to train under an industry expert and understand solutions for some of the most common challenges in the process.

This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.

This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.

This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).

This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.

This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.

This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.

This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.

This webinar will show how you can devise a clinical trial billing system/ process to manage the billing of clinical trial charges in compliance with Federal rules and regulations.

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

This clinical research QA training will provide practical advice for clinical research sites on when and how to get started with building their quality assurance program. A table of contents of the most critical SOPs will be provided.

This 3-hr virtual seminar will offer a comprehensive ICH GCP training for all healthcare professionals involved in clinical research.

This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.

This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.