FDA GCP Enforcement Trends CONTENT Package

This one hour webinar recording and PowerPoint training presentation review a number of critical regulatory agency GCP noncompliance trends that have appeared as audit observations in FDA Warning Letters  and other regulatory agencies observations over the past couple of years.

This content package includes:

➢1. FDA GCP Enforcement Trends: (Webinar Recording)

➢2. FDA GCP Enforcement Trends (PowerPoint Training Presentation)

Click here to view excerpt

1. and 2.:Click here to view excerpt

In addition to identifying critical trends, this presentation also presents each observation with a number of CAPA (solutions) to address each audit observation below, including:

➢ Informed consent process
➢ Investigator sites
➢ Sponsors
➢ Investigator oversight
➢ Sponsor trial management
➢ Protocol violations
➢ Management of investigational products
➢ Source documents
➢ Electronic source
➢ Essential documents

While the majority of the presentation is based on violations of FDA regulations, Health Canada, MHRA, EMEA information is also reviewed. Chris draws on her own experience as an auditor in this presentation, as well.

About the Presenter

Chris Brouillard-Pierce is an independent Clinical Quality Assurance (CQA) consultant with over 20 years experience in clinical research. Since 1996, her primary focus has been in the areas of GCP training and quality assurance-providing CQA expertise and conducting GCP industry audits (i.e., pharmaceutical, biotech, CROs and investigator sites), performing GCP audits of investigational product and investigational device clinical trials (Phase I-IV) throughout North America and the UK. In addition, she has hands-on experience in assisting sponsors and investigator sites in preparing and responding to regulatory inspections.

FDA GCP Enforcement Trends CONTENT Package is only $99.00