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Webinar On Current GMP Requirements for Combination Products - Final Rule

  August 27, 2014  

Compliance Trainings, Canada

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To deal with these complexities, the FDA published draft guidance for the application of GMP to combination products.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 Covered in the Session :

    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    The Draft Guidance vs. The Proposed Rule Vs.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


Price Tags:


Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899


Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

Organized by: Compliance Trainings
Invited Speakers:

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.

Deadline for Abstracts: 2014-09-04


E-mail: suzzane.d@compliancetrainings.com
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