Role of the Sponsor in Preventing a Site from Receiving a FDA Form 483 or Warning Letter

Event Information
Product Format
Prerecorded Event
Presenter(s)
Charles H Pierce, MD, PhD, FCP, CPI
Conference Date
Tue, Oct 20, 2015
Length
90 minutes
Product Description

Know How to Prevent Audit Findings That Lead to a FDA Form 483 or Warning Letter!

 

A clinical research study sponsor plays a vital role in the drug development process – starting with preparing a complete Investigator’s Brochure, a safe study protocol, and providing effective data. Sponsors are also responsible for choosing sites and principal investigators (PI) who will conduct the study according to clinical research GCP and federal regulations. Additionally, they must monitor the study to ensure data validity and integrity, and correct reporting to the regulatory authorities.

GCP investigator site and sponsor audits are a routine and a necessary part of the clinical trial process. If you are a sponsor or are participating in a clinical trial or multiple trials as a PI, a study coordinator, a monitor, or even as the IRB, chances are that you may be audited.

This webinar by our expert speaker Charles Pierce, MD, Ph.D., FCP, CPI, will cover the most frequently found GCP violations / mistakes that are often found during the audit process. You also learn how to prevent audit finding that can land your organization in trouble. Charles will review FDA inspection program details and guide you to ensure your site is prepared for an inspection. You will understand the key components of a good audit program; get helpful hints to help you avoid the common GCP mistakes; and tips to enhance the overall audit experience.

Take a good step toward the challenge of learning the FDA processes and learn the importance of a knowledgeable sponsor and PI. Know the mandates for a sponsor, how they apply to an audit outcome, and how they relate to the PI’s responsibilities. Get a better understanding of sponsor responsibilities according to the ICH:

  • Trial Design – Clinical pharmacologically, statistically, ethically and medically sound protocol
  • Trial Management – Data handling, record keeping, statistical analysis, reports etc.
  • Investigator selection – Qualifications, experience, resources to guarantee GCP
  • Product Safety and Efficacy - The Investigator’s Brochure
  • Study Monitoring - Responsibilities, purpose, extent, procedures, and reporting

Session Highlights:

  • What are the responsibilities of sponsor in ensuring quality monitoring?
  • Why monitor clinical studies?
  • What does a sponsor’s monitor look for?
  • How to prepare a site or sponsor for an audit?
  • What is the importance of a well written protocol?
  • What are the top 6 GCP problems found by monitors?
  • What are the main strategies to improve an audit outcome?
  • What does the FDA go through while inspecting/auditing a study?
  • What are the different types of studies targeted for auditing?
  • What is the role of the sponsor in the preparation of a site for an audit?
  • What are the common GCP mistakes?

Learning Objectives:

  • Get new knowledge regarding the sponsor’s responsibility
  • Apply at least three strategies to improve audit outcome
  • Compare the sponsor’s responsibility with that of the investigator’s
  • Utilize audit preparation tools identified in this presentation
  • Identify at least four mistakes found during an audit
  • Know how to prevent each of the top audit findings that would lead to a 483 or warning letter
  • Be able to compare your experience in an inspection with the examples given here

Who should attend?

This webinar will provide invaluable assistance to all personnel in the pharmaceutical, biotechnology, and CRO industry who may be called upon to conduct clinical trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance personnel. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA/QC auditors and staff, and Clinical Research Data managers.

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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1-919-287-2643

About Our Speaker

Charles H Pierce

Charles H. Pierce, MD, PhD, FCP, CPI


From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...   More Info
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