If you answered yes to the first question and no to the second then this course is a must for you….
This course has been designed to provide you with the necessary skills and tools to navigate the preparation and hosting of GCP regulatory agency inspections in a rapidly changing environment where the way inspections are conducted and the focus of inspection is ever-changing.
Provide the necessary skills and tools to prepare and host GCP regulatory agency inspections
Tutors will be comprised of (click the photos for biographies):
34 years within the Pharma/Biopharma industry with 26 years experience in Quality Assurance and Compliance. Currently responsible for a global team managing internal significant issue investigations, serious breach notifications and regulatory inspections for both Sponsor and clinical site inspections, operating a flexible working model, to support the needs of each inspection.
Please note timings may be subject to alteration.
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
You will need a stable internet connection, a microphone and a webcam.
Develop
CAPA: Effective approaches to improvement eBooklet
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet