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

This training program will identify regulations and guidelines pertaining to institutional review boards. Attendees will learn about the historical events leading up to today’s regulatory framework in clinical research as well as discuss recent ethical issues regarding the IRB. The course will also explore the emergence of IRBs that are not academically affiliated.

This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.

This training program will explain what the critical areas and elements of vendor oversight are and how you can set such a system up for yourself at your company.

This training program will take an in-depth look at various clinical research contracts designed for different purposes. Understanding each type including what is being protected and who is being protected is an important part of ensuring compliant administration and management of clinical research activities. Beyond the legal terms, this course will examine the standards for accredited organizations and best practices for ensuring the broadest protections for study participants.

This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.

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 analyze the importance of research risks defined in 21 CFR 50 and 45 CFR 46. It will delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50. The program will also discuss the need for indemnification language in consent forms based on risk levels.

At the end of this training program, participants will be able to differentiate between consent and assent, identify when to use the long form and when to use the short form, describe the consent process using best practices.

This program will identify regulations and guidelines pertaining to investigational device exemptions. Participants will learn to translate regulations and guidelines into practical application. The program will also discuss the dos/don’ts for conducting device trial activities through real-life examples.

This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.

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 medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.

This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

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 on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs.