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FDA Licensure Rules, Identifying Trading Partners & Interoperable Exchange Standards
September 13 @ 2:00 pm - 3:00 pm EDTFREE
Register to learn about the US FDA’s newest draft guidance published in July 2022 – Standards for the Interoperable Exchange of Information and Identifying Trading Partners Under the DSCSA. These new guidance’s contain revisions to their original guidance issued in 2014 and 2017, respectively. Join us and take a deeper look at the enhanced drug distribution security requirements that impact manufacturers, wholesale distributors, dispensers, and repackagers who engage in the transaction of products. Learn how these guidance’s impact you as they identify the standard for uniform methodology related to product tracing and the identification of trading partners.
We are excited to also include in this webinar a look into the February 2022 FDA proposed rule – National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers. This rule will change the way WDDs and 3PLs manage State and Federal licensing. Listen in to learn what the FDA has proposed to help harmonize compliance across states and to help avoid supply chain disruptions related to licensing uncertainties.
DSCSA is the most complex regulation to date for pharmaceutical manufacturers, wholesale distributors, and dispensers. Attending this webinar will help attendees learn new the rules and regulations and identify the ‘must have’s’ to fluidly implement any process changes needed based on the DSCSA guidance. The benefits for attendees include:
1. Acquire the knowledge needed to work in an FDA regulated environment
2. Keep up with the new regulations, standards, and the latest changes to help your company adhere to compliance requirements
3. Gain a broader perspective and insight of interoperability, trading partners and licensing in the supply chain
4. Learn the best practices and tools available to improve your DSCSA operations
5. Meeting cGMP and DSCSA training requirements