Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products - Webinar By GlobalCompliancePanel November 14, 2012

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: 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

David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, GxP compliance, auditing, interfacing with the regulatory agencies, managing enforcement actions and mitigating compliance exposure for companies, working with Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a well-known CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/Qyqao6