The inspection is complete and the inspector has left the premises! You may believe it is time to breathe a sigh of relief, but don't relax just yet. You may now need to provide a written response to one or more GCP inspection findings. In this interactive presentation, you will be able to take part in developing response strategies to actual findings issued by Health Canada, FDA, and EMA
Taking each case study and analyzing the root of the non-compliance identified by a regulatory agency during an actual GCP inspection, the speakers will guide the audience through what the site and sponsor must do to provide an effective response taking into consideration: Sponsor/site motivations, site team members (who write the response), stakeholder team members (who review the response), the regulatory agency (who will read the response), commitment required (CAPA and follow-up), content and organization of the response, and follow-through to response completion.
- Identify stakeholders involved in preparation of a response to inspection findings and describe workflows for coordinating an effective inspection response team.
- List steps to be taken in a root cause analysis of an inspection finding and identify required elements of an effective corrective and preventive action plan.
- Describe key elements to be included within an inspection response.
Registration Information: Click the "Register Now" button the right to register for this event.
Contact Hours: 1 contact hour has been approved for through ACRP. Membership is not required for online registration/application of contact hours. Purchase contact hours for this event here.
To receive contact hours: Purchase the contact hours, sign in at the registration desk and attend the program. Log on to the ACRP website then "ACRP Learning Portal" to complete the evaluation no later than 30 days following the event and obtain the online certificate. After 30 days, contact hours are no longer available. #ClinicalResearchCoordinator #DirectororManagerofRegulatoryAffairs #TrialManagement #OnlineTraining #DirectorofScientificAffairs #Intermediate #StudyConduct #RegulatoryAffairs #Advanced #StudyandSiteManagement #ClinicalTrialsOperationsandGCPs #DirectororManagerofClinicalTrialOperations #ProjectManager