FDA Pre-Approval Inspection 2016 - FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection - By Compliance Global Inc

Overview:
Are you ready with your FDA audit preparation? An overview of the Compliance Program Guidance Manual for Investigational Sites and Sponsors for FDA audit readiness will be reviewed, as well as the BIMO inspection site audit checklist.
Why Should You Attend:
Attendees will learn what increases the risk of inspection, what types of inspections are conducted by BIMO, how to successfully prepare your site/facility and personnel, and how to interact with the FDA inspector.
Areas Covered in this Webinar:
When an inspection is likely to be scheduled
What types of BIMO inspections can be conducted
Become familiar with key FDA inspection terminology
What the FDA inspector will ask to see, and current trends in findings
Site inspection procedures
Sponsor inspection procedures
Learning Objectives:
Learn how to Identify key personnel and why it is important to have SMEs (Subject Matter Experts)
Strategies for successful interactions with a FDA Inspector
Who Will Benefit:
Regulatory Affairs Personnel
Regulatory Coordinators
Clinical Research Coordinators
Principal Investigators
QA/QC Staff
Speaker Profile:
Nicole began her career in Clinical Research over 17 years ago as a Clinical Research Associate for a small Clinical Research Organization. The “accidental” career that began after receiving her undergraduate degree has proven to be rewarding, challenging and continues to inspire her to do more and learn more in the field of Clinical Research.
Nicole has held roles such as CRA, Lead CRA, Project Manager, Regional Operations Manager, and Auditor.
In 2013 she started Harmony Clinical Consulting, providing consulting services to the pharmaceutical and biotech industries.
Nicole has experienced working for “Big Pharma” as well as small Biotech companies. Her focus is in Oncology, rare disease and orphan drugs has provided her with the opportunity of being a contributor in the development of Myleran® (Busulfan) for Pediatric BMT, Herceptin® (Trastuzumab) for Metastatic Breast Cancer, TYKERB® (Lapatinib) for Breast Cancer and MYALEPT® (metreleptin) for Lipodystrophy.
Nicole is currently working as an independent consultant for Acerta Pharma BV in collaboration with The Ohio State University on a second generation BTK inhibitor to treat Chronic Lymphocytic Leukemia.