Defining and Managing Protocol Deviation/Violation/Exception
Instructor:
Calin Popa
Product ID: 704953
Training Level: Intermediate
- Duration: 90 Min
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 you to understand, correct and prevent potential protocol deviations/violations.
Areas Covered in the Webinar:
- ICH guidelines and Good Clinical Practice (GCP)
- Differences between protocol deviations/violations/exceptions
- Understanding compliance
- Most frequent audit findings
- Finding Protocol deviations/violations
- Developing a CAPA plan
Who Will Benefit:
- Clinical trial sponsors study team
- CROs study team
- Study managers, Clinical team leads, CRAs
- Principal investigators, site managers and study coordinators
- New Clinical Research Coordinators (1-2 years)
- New Principal Investigators
- Regulatory Compliance Associates and Managers
Calin Popa
Founder and President, Advanced Clinical Research Services Inc
Calin 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.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
