combination products: fda's proposed
DESCRIPTION
This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination productsTRANSCRIPT
Date : Thursday, July 28, 2011
Time : 10:00 AM PDT | 01:00 PM EDT
Duration : 60 Minutes
Price : $245.00
Live Webinar
Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
Overview: This webinar will provide valuable assistance and
guidance to device companies in involved in commercialization
of combination products.
What is a combination product? What are some examples of
combination products? How are combination products
assigned for review? Where can I find guidance for how
master files can be used in the submission of information
relevant to my combination product? Determine which Center
will review my combination or non-combination product?
These topics and more will be addressed during this Webinar,
including recently FDA's proposed rule to codify the current
good manufacturing practice (cGMP) requirements applicable
to combination products.
Areas Covered in the Session:
l Introduction to Combination Products if you design,
develop, produce, distribute and deploying a
sustainable regulatory strategy
l Description and explanation of FDA's proposed rule
l Requirements for Single-Entity and Co-Packaged
Combination Products
l Identify requirements that apply to the constituent
parts of a Combination Product before they are
combined, or packaged together
l What current good manufacturing practice
requirements apply to my combination product?
l Learn FDA's new terms and phrases
l Understand how to address a Request for Designation
for a combination or non-combination product and
examples of “combo” products
l Resources and guidance to help define a proven
regulatory strategy
Click here to register for this webinar
Who Will Benefit:
l All levels of management and departmental
representatives and those who desire a better
understanding or a "refresh" overview
l Regulatory Affairs
l Clinical Affairs
l Quality and Compliance
l Marketing & Sales
l Distributors
l Engineering/Technical Services/Operations
l Consultants
Register Now
Instructor Profile:
David R. Dills Industry Regulatory & Compliance Consultant
David R. Dills, an independent
Regulatory & Compliance Consultant
with more than 22 years of hands-on
experience and a proven track
record within the FDA regulated
industry, has an extensive
regulatory and compliance
background with Class I/II/III and
IVD devices and managing and
handling activities within the global
regulatory and compliance
landscape. He manages quality,
regulatory and compliance projects
with multiple competing priorities
having a direct impact on site
operations and commercial
opportunities and develops
strategies for governmental approval
to introduce new products to market,
provides guidance and direction on
regulatory and compliance
requirements and prepares/reviews
worldwide
submissions/dossiers/technical files
and addresses requirements in the
EU, Pacific Rim and The Americas
regarding all aspects of device
commercialization and especially FDA
activities. Background encompasses
broad capabilities in quality systems,
validation, regulatory affairs, GxP
compliance, auditing, interfacing with
the regulatory agencies, managing
enforcement actions and mitigating
compliance exposure for companies,
working with Notified Bodies, AR’s
and demonstrates credible
experience to maximize business
performance in the devices arena.
...more
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Your Necessity is our Priority
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit
from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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