FDA's Final Rule for GMP 2016 - Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products - By Compliance Global Inc

Overview:
What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Why Should You Attend:
These topics and more will be addressed during this Webinar, including FDA rules to codify the GMP requirements, current good manufacturing practice (cGMP training) 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 training 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 pre-emption provisions of the act applicable to prescription drugs or biological products.
Areas Covered in this Webinar:
Introduction to Combination Products if you design, develop, produce, distribute and deploying a sustainable regulatory strategy
Description and explanation of FDA rules and regulations
Requirements for Single-Entity and Co-Packaged Combination Products
Learning Objectives:
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 "combo" products
Resources and guidance to help define a proven regulatory strategy
Who Will Benefit:
All levels of Management and Departmental Representatives and those who desire a better understanding or a "refresh" overview
Regulatory Affairs Personnel
Clinical Affairs Personnel
Quality and Compliance Personnel
Marketing & Sales Professionals
Distributors
Engineering/Technical Services/Operations Personnel
Consultants
Speaker Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.
Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives.
Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.