Clinical Research Regulations and Guidance Training - Live Webinars, Recordings & CDs

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 focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.

This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.

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 review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.

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 training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.

The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

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 FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).

This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.

This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.

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.

The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.