Thursday, September 20, 2018
2 pm ET / 11 am PT
This webinar will provide a brief overview of the current FDA BIMO inspection process for clinical research sponsors and investigators, and discuss the challenges innate in inspections conducted within the complex, dynamic, medical environment. The skills, qualifications, approaches and inconsistencies of inspectors can have a huge impact on sites and sponsors. Using actual examples from inspections, these challenges will be reviewed, including the variability in inspectors deciding to issue (or not issue) a 483. In addition, the unintended consequences of a resulting 483 will be examined. The speaker will challenge attendees to consider some potential opportunities for improvement to help ensure the FDA BIMO Inspection process yields more consistent, meaningful outcomes.
In this webinar we will:
- List at least 3 areas the FDA may inspect during a FDA BIMO Inspection of a sponsor/CRO or an investigational site
- Discuss at least 3 challenges that are innate in the inspection of a complex, dynamic, clinical environment
- Discuss at least 2 unintended consequences following FDA’s issuance of a Form 483
- Discuss potential opportunities for improvement in the FDA BIMO Inspection program
Sandra Maddock, RN, BSN, MSHS, CCRA
IMARC Research, Inc.
Medical Design and Outsourcing