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CGMPs for Combination Products—Final Rule and Implementation

An Interactive Analysis with Industry and FDA

28 February 2013
RAPS Training Center
Rockville, MD

On 22 January 2013, the US Food and Drug Administration (FDA) issued the final rule on current Good Manufacturing Practices (CGMPs) for combination products. This highly anticipated rule is intended to clarify how the agency’s GMP requirements apply to the manufacturing operations of combination products companies. While the final rule did not change significantly from the proposed rule, the agency indicated that many of the existing ambiguities will be clarified through guidance documents.

Offered in collaboration with the Combination Products Coalition (CPC), this program offers the unique opportunity to examine the contents of the final rule and the agency’s implementation plan with representatives from FDA’s Office of Combination Products and industry peers. You will hear directly from experts at each of the FDA centers and industry regarding what the final rule includes, with an emphasis on deviations from the proposed rule, as well as how the final rule may affect you and your company.

Working intensively in small groups facilitated by experts from CPC, you will use a case study approach to apply the final rule and analyze the rule’s remaining ambiguities and identify approaches for effective implementation. You will then benefit from a final recap session during which the expert facilitators will present and connect major themes identified during the breakouts, allowing for organic discussions and problem solving by the group as a whole. Additionally, you will have the opportunity to provide feedback directly to the experts at the various centers responsible for developing the implementation guidance regarding any other ambiguities not addressed in the case studies.

As well as the opportunity to provide feedback directly to FDA experts during the program, RAPS and CPC will collaborate to compile the major themes that emerge from the program regarding implementation and submit them as comments that FDA will consider when developing its guidelines for implementation. Don’t miss your opportunity to provide your input on this pivotal issue.

At a Glance

Dates: 28 February 2013

Discover: Rockville, MD, US

Meeting Location: RAPS Training Center

Advance Registration Deadline: 26 February 2013

On-site Registration Available: No
Please note that capacity for this program is limited. RAPS encourages participants to register early to confirm participation.

Cancellation Deadline: 21 February 2013

RAC Points: 5

Will this meeting be recorded?: Yes

How do I obtain a Certificate of Attendance for this meeting?:
You will receive an email following the conclusion of the meeting. This email will contain your Certificate of Attendance.

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Registration Fees:
$495 member
$495 nonmember

Learning Objectives

At the conclusion this program, participants should be able to:

Explain key differences between the proposed and final rules
Describe the final rule’s impact on their business and operations
Provide feedback on the implementation guidelines to be developed by FDA
Assess potential implementation plans needed to achieve compliance with CGMPs for combination products

Who Should Attend

This program is intended for manufacturers (including contract manufacturers), combination product developers, consultants and legal counsel who are involved in regulatory, quality and compliance at all professional levels.

Agenda

Time	Session
10:00–11:00 am	Registration
11:00–11:10 am	Introduction Overview of the day, including introduction of speakers, the background of the proposed rule and the purpose of the program
11:10–12:00 pm	Examining FDA’s Final Rule Presentations by US Food and Drug Administration (FDA) representatives on what the rule is, highlighting differences between the proposed and final versions. FDA representatives will give their perspective on what they see as key remaining areas of ambiguity.
12:00–12:20 pm	Understanding the Differences from Proposed Requirements – An Industry Perspective An industry representative will discuss major differences between the proposed and final rules in practical terms. The speaker will walk through a few case studies to illustrate key points of differentiation. The speaker also will talk about the case study exercise. The goal is to summarize remaining points of ambiguity, how these points would play out in the exercises and how the groups can come up with suggestions to help inform the implementation guidance.
12:20–1:30 pm	Working Lunch: Applying the Final Rule—Case Study Exercise (Not Broadcast via Webcast) Participants break into six groups and work through various scenarios subject to final rule.
1:30–2:45 pm	Case Study Exercise Results Part 1 The first four of the six group leaders present top themes found in their groups. Remote participants will be able to contribute their questions and comments.
2:45–3:00 pm	Break
3:00–3:30 pm	Case Study Exercise Results Part 2 The last two group leaders present top themes found in their groups.
3:30–4:00 pm	FDA Panel Discussion Experts from FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research and Center for Devices and Radiologic Health will participate in an interactive discussion regarding the implementation of the Final Rule. This discussion also will give attendees the opportunity to provide feedback to FDA regarding additional topics, not addressed in the Case Study Results, that need to be clarified through guidance or other means.

CGMPs for Combination Products—Final Rule and Implementation

An Interactive Analysis with Industry and FDA

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