With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of Protocol and Good Clinical Practices (GCP) violations has gained more importance, evident by the increase in Warning Letters. To know the protocol and other GCP violations that an FDA audit and inspection may reveal is a great insight for your site. In this case, the adage “forewarned is forearmed” clearly applies.
GCP investigator site audits are a routine and a necessary part of the clinical trial process. If you are participating in a clinical trial or multiple trials as a Principal Investigator, a study coordinator, a monitor, or even as the IRB, chances are that you may be audited.
Join expert speaker Charles H. Pierce, MD, PhD, FCP, CPI in this webinar to uncover the most frequently found GCP violations / mistakes that are often found during the audit process. In addition, you will learn how to prevent audit findings you wish were not there. This webinar will review FDA inspection program details and how to ensure your site is prepared for an inspection. Focus areas would be key component identification of a good audit program.
Charles will give you helpful hints to help you avoid the common GCP mistakes and hints to enhance the overall audit experience. Attending this webinar is a good step toward the challenge of learning the FDA audit processes and why a knowledgeable PI is so important.
You will learn from a collection of rare books and resources on FDA investigations and audits, including:
Who should attend:
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 persons. 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, & Clinical Research Data managers
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...
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