Current GMP Requirements for Combination Products – Final Rule

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As you know, medical diagnosis, technology, and treatment is very dynamic and is rapidly advancing. New discoveries are made that do not fit the “regulatory mold “and thus require new approaches to regulation. Combination products is one such area that has grown proportionally as technology advances creating in the need to rethink the processes for classification, design, quality assurance, and regulatory approval of such products. This challenges industry and the FDA to develop strategies for effectively working together to meet user and customer needs. As a professional, you are aware of the complexities of also combining the regulatory, business, and quality processes to make such products a reality.

To deal with these complexities, the FDA published draft guidance for the application of GMP to combination products. The FDA determined that these requirements should be formalized in the Federal Register. The proposed rule was published in 2009 and the final rule was published on December 22, 2012 and was effective July 22, 2013. This webinar discusses this final rule and describes approaches to comply.

At the end of this session, you will be able

To understand where the combination products GMP rule applies.
To learn & understand the differences between drugs, biologicals comments and after devices & their modes of actions
To understand how they interact to produce combination products
To learn and understand how to apply the regulation to your product and operations
To gain additional perspective on how to apply quality principles to solve compliance problems

Areas to be Covered:

Objectives & Overview
The Draft Guidance vs. The Proposed Rule Vs. The Final Rule
A quick review of the Pharmaceutical, Medical Device, and Biological GMP Contents
A Quick Overview and Analysis Of Industry Comments and the FDA Responses
Who is in charge of your product CDER,CBER,CDRH
Scope, applicability and factors that impact the manufacturing
Quality and compliance perspectives of the Final Rule
FDA’s discretionary enforcement of the Final Rule
Reviewing, Analyzing, & Understanding the Final Rule
21 CFR Part 4, Subpart A
Practical Suggestions for complying with Combination Product cGMP Subparts
Beyond the regulation and its impact

Who will Benefit:

QA / QC Managers and personnel
Regulatory Affairs
Product Management
Supervisors & Group Leaders
Production Management
Companies new to the FDA regulated industry
Compliance Management
Quality Unit Vice Presidents & Directors
Vice presidents, Directors and Managers of Operations

Howard T Cooper, President, EQACT, Inc., Independent Consultant, has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader. Mr. Cooper built on this experience to set up a pharmaceutical /medical device in combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance