Clinical Research Audits and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 60-minute training program is designed for those working in the field of clinical research either as a sponsor (pharmaceutical/biotech company) or a research site. The session will discuss key FDA inspection terminology, types of BIMO inspections, site inspection procedures, and sponsor inspection procedures. Attendees will understand when an inspection is likely to be scheduled and the current trends in findings.

This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will critically assess the number of major and critical 2012 inspection findings related to trial oversight. Attendees will learn to identify regulatory requirements for appropriate delegation of duties and investigator oversight.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This training program will discuss latest requirements for monitoring plans, content and process requirements including FDA monitoring guidance and EU requirements. The webinar will help, sponsors, and CROs in the US, EU and internationally, understand how to effectively draft monitoring plans and comply with the latest FDA and EU inspection requirements for monitoring clinical trials.

This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

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 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 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 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 webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

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 webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.

This webinar will cover definitions, responsibilities, regulatory requirements and strategies to conduct Investigator Initiated (Sponsored) Trials - ISSs. It outlines the processes a company or investigator must undertake to be able to conduct such a clinical research study in humans.