By : Compliance Online
Date : 2012
Location : California / Palo Alto
This clinical trial audit webinar will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit.
Clinical Trial Auditing, Risks in Clinical Trials, FDA clinical trial audit procedures
With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part in the idea to try to downsize the risk of noncompliance during the trial.
This clinical trial audit webinar will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. The session will give you practical solutions to get the best results from an audit and the opportunity to grow the image of your team and/or your site. This session will include the key principles of audit preparation, GCP as defined by the ICH as well as incorporate FDA regulatory inspection strategy to identify areas of common deficiency.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Clinical trial sponsors study team
- CROs study team
- Study managers, Clinical team leads, CRAs
- Principal investigators, site managers and study coordinators
- Regulatory Compliance Associates and Managers
Areas Covered in this Webinar:
- Key aspects of the role and key players involved in a trial.
- Understanding compliance.
- Most frequent audit findings.
- Audit preparation.
- Activities that are common to audits.
- Linking responsibility to these activities.
- Responding to audit findings.
Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries.
He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria