Description

New 21 CFR Part 11 regulations and how to comply with them.

Why should you Attend

With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. 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 presentation will help with preparing the site and the study team with how to comply with the new 21 CFR part 11 regulations, how to identify risk of noncompliance, and how to insure compliance.

Areas Covered in the Session

Learning about preventing noncompliance during the clinical trial development and about preparing well for an audit.

Who will Benefit: (Titles)

Clinical trial sponsors study team
CROs study team
Study managers
Clinical team leads
CRAs
Principal investigators, site managers and study coordinators
IT and Data Managers

About Speaker

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 provides ICH-GCP training and training for FDA and Health Canada regulations. 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 works close wih companies and sites to prepare them for audits. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.