FDA & IRB Inspections: What Sites Need to Know
This webinar was recorded on June 29, 2017
If you’re conducting trials as a Principal Investigator, a study coordinator, or a monitor, eventually you may be audited. FDA and IRB inspections can be a daunting experience- especially if you’re unprepared. This webinar will provide information on FDA inspections, forms, and Warning Letters. Joan Chambers of CenterWatch joins industry thought leaders, Dominic Chiarelli of Kinetiq, and Terry Stubbs of ActivMed Practices & Research, to help you understand what to expect in the event of an audit.
Key Topics Covered:
- What the FDA looks for during an inspection
- What sites need to do to prepare
- Common findings of inspections
- Frequently Asked Questions about FDA inspections
- Identify common mistakes made during an audit
- Understanding strategies to improve audit outcome
- Developing responses to FDA observations
This webinar was recorded on June 29, 2017. The full recording is available on demand.
About the Presenters:
Chief Operating Officer for CenterWatch
A well-known speaker at industry conferences and symposiums, Joan has presented on a wide variety of topics specific to the clinical trials enterprise. In the course of her career, she has also published in clinical trade journals. For five years, she was an instructor for Barnett International’s CRA/CRC programs on the site identification/qualification process. Joan is on the Advisory Board for BioBridges, Board of Directors for Greater Gift Initiative (GGI), and The Center for Information and Study on Clinical Research Participation (CISCRP), and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA).
Prior to joining CenterWatch in April 2010, Joan spent two and a half years with Cambridge Healthtech Institute as Senior Director of Marketing & Operations-Publications; two and half years with the Tufts Center for the Study of Drug Development at Tufts University as Director of Strategic Marketing & Development; seven and a half years with Thomson CenterWatch as Senior Director of Marketing & Sales; and four years working for PAREXEL International as Site Selection Specialist. Joan holds a B.S. in Marketing.
Manager, Legal & Regulatory Affairs, Kinetiq
Dominic Chiarelli is a clinical research expert and regulatory consultant with a focus in pharmaceuticals, devices, and data. He has a broad understanding of the biomedical research context due to hands-on experiences in clinical research, intellectual property and business. He is an IRB member, attorney, and registered patient agent.
As a regulatory analyst and IRB member with Seattle Children’s Research Institute Dominic gained experience analyzing clinical trials according to the FDA, OHRP, and HIPAA federal regulations. He currently works as a Legal & Regulatory Affairs Manager at Kinetiq. Kinetiq works with clinical researchers, research institutions, and pharmaceutical, biotechnology and medical device companies – as well as others around the world – to develop contemporary approaches to a changing landscape.
Terry Stubbs MA,CCRC
President and CEO ActivMed Practices & Research, Inc.
Terry is a true Entrepreneur , running a women owned business in research since 1994.
She has moved up the ladder from a lab tech to a research coordinator, to a founder and owner of several research offices in New England. During this time, she has contracted and completed over 700 clinical research trials. During the past 25 years, she has been devoted to working in the field of clinical research, helping scientists find new treatments for illnesses by working with local area physicians and hospitals.
For the past 8 years, she has been a speaker for numerous medical research conferences including MAGI and Centerwatch, as well as 20 webinars regarding budget and contracting. Her goal is to continue to offer quality clinical research opportunities to area physicians and hospitals, as well as those individuals seeking and interested in participating in a clinical trial. She has 38 years of business experience.