FDA’s Combination Products and Its Impact on Manufacturers of
Pharmaceuticals, Biopharmaceuticals, Medical Devices and HCT/P – The Final
Guidance, “Current Good Manufacturing Practice Requirements for Combination
Products”. January 2017
Tuesday July 31, 2018
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Historically, the absence of clear cGMP requirements for Combination Products has
resulted in inconsistent application as to the applicable Agency Center to submit product
for review. Products for both CDER and CDRH as the primary Agency contact point
may have historically been submitted to the incorrect organization for review because of
a lack of knowledge as to the Primary Mode of Action (PMOA) of the product. While
some of these product applications might have been relatively easy to discern, e.g., a
pre-filled syringe (usually CDER), other products may have had great difficulty finding
the “correct home”.
In October 2004, the FDA issued a Draft Guidance for Industry entitled “Current Good
Manufacturing Practice for Combination Products”. Nine years later, the FDA codified
(January 2013) the cGMP requirements applicable to combination products. In January
2017 the FDA issued their final Guidance for Industry entitled “Current Good
Manufacturing Practice Requirements for Combination Products”. This recent rule is
intended to promote the public health by clarifying which cGMP requirements apply
when drugs, devices, biological products and human cell and tissue products (HCT/Ps)
are combined to create a combination product. This permits both a client company and
the FDA to move the product through the regulatory system most efficiently. The new
rules also discuss a transparent and streamlined regulatory framework for firms to use
when demonstrating compliance with cGMP requirements for single-entity and co-
packaged combination products.
The objective of this live, interactive Executive Conference Corp. training webinar is to
explore this recent rule and guidances for the industry as they apply to your
organization and examine options for obtaining compliance within a cGMP framework.
By attending you will learn:
- The recent 2017 cGMP Requirements for Combination Products
- Clarification of the cGMP Requirements that apply to Combination Products.
- Ensuring the Consistent and Appropriate Application of these Requirements.
- Examination of the various Guidances for Industry.
- Determining the Primary Mode of Action (PMOA).
- Learning how to streamline the Practical Implementation of cGMP Requirements.
- Ensuring that cGMPs for Co-Packaged and Single-Entity Combination Products are
Consistent and Appropriate without Duplication. - Determining what new cGMP Requirements may be required.
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
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