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

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. 

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 "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

Speaker Profile:

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.