Friday May 18, 2012 Friday May 18, 2012
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| Date: Friday, April 13, 2012 | |
| Registration Single Attendee: CAD $195.00 Group rates are available. (see below) All rates are subject to the Canadian 13% Harmonized Sales Tax (HST) |
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Time: 1:00 PM ET | 10:00 AM PT | Duration: 2 hours |
This webinar addresses the FDA inspection process according to their Bioresearch Monitoring Program (BIMO). The BIMO program covers FDA Inspections during the Pharmaceutical/Medical Device research/development process. Inspections for GCP, GLP and GMP for New Drug Applications, Biologic Licensing Applications, 510(k) Applications and Premarket Approval Applications. This webinar also addresses how FDA is trained to conduct such inspections, how sites for inspections are determined and how the FDA inspection process works.
Compliance, Regulatory, Quality, Research personnel involved in FDA Inspections. Auditors, Project Managers, Legal Personnel, CRA and Medical Monitors will also benefit from this webinar.
Mr. Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.
He lectures throughout the world on numerous FDA related matters. He is one of the trainers FDA uses to train their reviewers and field force. In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.
In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.