Online Webinar 2019 - Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

Session Highlights
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 "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
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors
Engineering/Technical Services/Operations
Consultants
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?
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.
Instructor Profile
David R. Dills, Independent Regulatory & Compliance Consultant, with an accomplished record has more than 22 years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance. Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all key stages of the product development, submission, and commercialization process, inspection readiness preparation, GxP compliance, execute audits and regulatory assessments, execute remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate QMS and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country device registrations. He has been previously employed, with increasing responsibilities by medical device firms and consultancies, including a globally recognized CRO.