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UID:2140535:Event:64632
DTSTAMP:20260525T122905Z
SUMMARY:Webinar On Current GMP Requirements for Combination Products -
  Final Rule
DESCRIPTION:As you know, medical diagnosis, technology, and treatment 
 is very dynamic and is rapidly advancing. New discoveries are made tha
 t do not fit the \"regulatory mold “and thus require new approaches 
 to regulation. Combination products is one such area that has grown pr
 oportionally as technology advances creating in the need to rethink th
 e processes for classification, design, quality assurance, and regulat
 ory 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 o
 f also combining the regulatory, business, and quality processes to ma
 ke such products a reality.\nTo deal with these complexities, the FDA 
 published draft guidance for the application of GMP to combination pro
 ducts. The FDA determined that these requirements should be formalized
  in the Federal Register.  The proposed rule was published in 2009 an
 d the final rule was published on December 22, 2012 and was effective 
 July 22, 2013. This webinar discusses this final rule and describes ap
 proaches to comply.\nAt the end of this session, you will be able\nTo 
 understand where the combination products GMP rule applies.\nTo learn 
 & understand the differences between drugs, biologicals comments and a
 fter devices & their modes of actions\n    To understand how they i
 nteract to produce combination products\n    To learn and understan
 d how to apply the regulation to your product and operations\n    T
 o gain additional perspective on how to apply quality principles to so
 lve compliance problems\nAreas Covered in the Session :\n    Object
 ives & Overview\n    The Draft Guidance vs. The Proposed Rule Vs. T
 he Final Rule\n    A quick review of the Pharmaceutical, Medical De
 vice, and Biological GMP Contents\n    A Quick Overview and Analysi
 s Of Industry Comments and the FDA Responses\n    Who is in charge 
 of your product CDER,CBER,CDRH\n    Scope, applicability and factor
 s that impact the manufacturing\n    Quality and compliance perspec
 tives of the Final Rule\n    FDA's discretionary enforcement of the
  Final Rule\n    Reviewing, Analyzing, & Understanding the Final Ru
 le\n    21 CFR Part 4,  Subpart  A\n    Practical Suggestions 
 for complying with Combination Product cGMP Subparts\n    Beyond th
 e regulation and its impact\nWho Will Benefit:\n    QA / QC Manager
 s and personnel\n    Regulatory Affairs\n    Product Management\
 n    Supervisors & Group Leaders\n    Production Management\n Â
  Â  Companies new to the FDA regulated industry\n    Purchasing\n 
    Compliance Management\n    Quality Unit Vice Presidents & Dire
 ctors\n    Vice presidents, Directors and Managers of Operations\nÂ
  Â Â  Consultants\nPrice Tags:\nLive\nSingle Live : For One Participan
 t\n$ 249\nCorporate Live : For Max. 10 Participants\n$ 899\nRecording\
 nSingle REC : For One Participant - Unlimited Access for 6 Months\n$ 2
 99\n\nFor more information visit https://medtechiq.ning.com/events/web
 inar-on-current-gmp-requirements-for-combination-products
DTSTART;TZID=America/New_York:20140904T130000
DTEND;TZID=America/New_York:20140904T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1062
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1062
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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