FDA Small Business Regulatory Education for Industry (REdI) Conference:
“Focus on CGMPs and FDA Inspections” Summer 2015
CDER Small Business and Industry Assistance (SBIA) invites you to our first topic specific two day conference. Join us as we “Focus on CGMPs and FDA Inspections”.
July 15-16, 2015
The Sheraton Silver Spring Hotel
Silver Spring, MD
This conference is FREE
You may attend in person or online
Advance registration is required
During these two days we will discuss the following six essential components of GMPs: Quality
Facilities and Equipment
Packaging and Labeling
We will also help you to identify what to expect when being inspected as we talk about:
FDA quality CGMPs
What FDA investigators do on inspection
What happens after an inspection
How to communicate with FDA during and after an inspection
Your right to dispute a finding or raise an issue
All presentations will address appropriate regulations and guidances and will allow time for questions and answers. We will end each day with an examination of specific case studies followed by availability of a panel for further questions.
We encourage you attend, interact and engage in productive two way communication with our FDA experts from the Office of Policy for Pharmaceutical Quality; Office Of Manufacturing Quality and Office of Process and Facilities.
Please honor your registration commitment. If you are registered and are unable to attend please firstname.lastname@example.org
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