Event Agenda
DATE: Wednesday, 16 November 2022
TIME: 6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION: This is an ONLINE event on zoom virtual platform
Register here
Program Details
This program will outline the basic concepts of preparing for a regulatory inspection for cell and gene therapy firms. Ranging from the first steps to the hour before the inspection starts, the presentation offers common sense guidelines on preparation, personnel readiness, management support, vendor involvement and presentation planning. Offering a 10-point plan based upon recent experience, this program offers up-to-date information on successfully passing an inspection.
Speaker Biography
Troy Fugate, Vice President of Field Operations, at Compliance Insight, Inc. utilizes approximately 30 years of FDA, Quality Assurance, Remediation, Compliance Development and Training skills to infuse GMPs into your organization’s DNA. Utilizing compelling GMP events to blend “insight” and “inspiration,” Mr. Fugate motivates clients regarding the enhancement and development of their quality systems, providing the support necessary to make product. He has been a partner within Compliance Insight since 2001 and serves the industry by providing:
- Strategic GMP compliance solutions and direction
- FDA issue mitigation and support
- Compliance Assessment for Risk (CAR)
- Development of standards for industry and regulatory agencies
Registration Information:
Register here
Contact
Pricing – Online – Registration (October 21, 2022 – November 15, 2022)
| Registrant Type | Price |
| Member | $10.00 |
| Lifetime | $10.00 |
| Non-Member |
$15.00
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|
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Cancellation Policy
There will be no refunds for cancellations.
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