Why You Should Attend
Electronic establishment registration/product listing
submissions for
drugs are required by US FDA as of June 1, 2009. Preparation
time — just to get to the submission process —
can be lengthy and complicated. These webinars will give you
the basics to help you fill out pre-formatted forms and send
the submissions.
Incorrect submissions can potentially cost
your company millions of dollars in lost time. Phoenix
Regulatory Associates, Ltd. presents the following two webinars
to help you avoid unnecessary costs and loss of your valuable
time. FDA compliance expert, David Clark, will guide you through
the electronic submission of Establishment Registration and
Drug Listing.
Who Should Attend
QA and Regulatory Staff and Managers and others who must
download, complete, validate, and submit the drug establishment
registration and drug listing documents electronically to
FDA
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Webinar #1:
Start-to-Finish:
Submission of Electronic Documents to FDA
Learn the basic requirements of the electronic submissions
guidelines and more. Additional
details...
Duration: 60 minutes |
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Webinar #2:
Start-to-Finish:
Completing Electronic Documents for Submission to FDA (Drug Listing)
Understand the details of electronic forms for Establishment
Registration and Drug Listings.
Additional details...
Duration: 75 minutes.
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| Want an Webinar on a different FDA topic? Please email us with your preferences. We are in the process of developing webinars on additional topics. Thank you. |
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Description of Training
These webinars describe the entire process from beginning
to end - and help you comply with the Agency's new final guidance
"Providing Regulatory Submissions in Electronic Format
- Drug Establishment Registration and Drug Listing". As
of June 1, 2009, FDA no longer accepts drug establishment
registration and drug listing information in paper format
unless the Agency grants a waiver.
Following participation in one or more of of our webinars,
we provide you with links to several helpful FDA pages and
email addresses to certain Agency offices/departments where
you can present any questions that you have during the actual
submission process. FDA
guidance for your reference.
Trainer Profile
David Clark has worked in the regulated industries
of pharmaceuticals and medical devices for 20 years on both
the manufacturing and quality assurance sides.
More information...
Cost
Individual Registration
$399/participant for each webinar; for two webinars, $650/participant.
Minimum number of participants for webinar to proceed is 5.
Group Registration
Volume discount for groups over 5 or more: $350/participant;
for two webinars, $599/participant.
Advance Payments Required: PayPal, bank transfer or payment
by check in advance. Purchase Orders (Net 30 days) can be
faxed to 703/406-9513. Please use
Registration form (PDF format).
Maximum number of participants per webinar is 15.
Schedule
Tuesday or Thursday at 11AM ET. All webinars require a group
of at least 5 participants to proceed.
Details
Meeting
Format and Cancellation
Policy
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