RAPS pre-approved webinar on "Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for 'Combo' Products" from GlobalCompliancePanel
"Combination products" is a broad term. The FDA describes it in fairly straightforward terms thus: "Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products." Although simple in description, the complexity lies in the fact that there are very many combinations in the market, and they all have to be regulated.
- Fresno, CA (1888PressRelease) February 28, 2013 - Description:
The FDA has recent updates on current Good Manufacturing Practices (cGMP) for combination products. These will be taken up during this webinar. Meant for safeguarding and promoting public health; these guidelines are meant to offer a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products.
Another highlight of the current cGMP is that the FDA proposes to create21 CFR Part 4, subpart A, which will codify the cGMP requirements for combination products. This webinar deals with this new section, and about how it applies to combination products. This webinar session will cover the following areas:
- 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 cGMP 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
When: February 28, 10:00 AM PST | 01:00 PM EST
By whom:
David R. Dills, Independent Regulatory & Compliance Consultant, worked for PAREXEL Consulting till July 2008, when he had to leave due to a service line organizational shakeup. Prior to joining the consultancy, Mr. Dills 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.
David currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He also serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and as Advisor for the ASQ's Section 1506. He is a former Chair and Co-Chair and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
For whom:
The webinar 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
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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