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Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products - Webinar by GlobalCompliancePanel

 
  September 22, 2010  
     
 


GlobalCompliancePanel, Online Training Webinar
2010-10-13


Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, including recently FDA's proposed rule to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products. FDA proposes to create 21 CFR Part 4, subpart A, to codify the cGMP requirements that apply to combination products. What current good manufacturing practice requirements apply to my combination product? The proposed rule seeks to clarify which cGMP requirements apply when drugs, devices, and biological products are used to create combination products. The agency notes that there are no express preemption provisions of the act applicable to prescription drugs or biological products.

Areas covered in the session:

  • Introduction to Combination Products if you design, develop, produce, distribute and deploying a sustainable regulatory strategy
  • Description and explanation of FDA's proposed rule
  • Requirements for Single-Entity and Co-Packaged Combination Products
  • Identify requirements that apply to the constituent parts of a Combination Product before they are combined, or packaged together
  • What current good manufacturing practice requirements apply to my combination product?
  • Learn FDA's new terms and phrases
  • Understand how to address a Request for Designation for a combination or non-combination product and examples of “comboâ€� products
  • Resources and guidance to help define a proven regulatory strategy

Who will benefit: This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products. Employees who will benefit include:

  • All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview
  • Regulatory Affairs
  • Clinical Affairs
  • Quality and Compliance
  • Marketing & Sales
  • Distributors
  • Engineering/Technical Services/Operations
  • Consultants
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.
 
Deadline for Abstracts: 2010-10-12
 
Registration:

Live live online training only for one participant Price: $245.00

Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) Price: $995.00

E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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