Webinar: US Drug Quality and Security Act (DQSA) - Overview
On Nov. 27, 2013, a comprehensive federal law was signed for pharmaceutical serialization, traceability and verification. Understand the requirements and business/IT implications.
Regulatory requirements and implications
H.R. 3204, the Drug Quality and Security Act, creates a federal pharmaceutical track and trace law replacing existing state-level ePedigree regulations. Pharmaceutical serialization, lot/unit-level tracing, transaction verification and other requirements start phasing in as early as Jan 1, 2015.
Law Text: Here is a link to the text of H.R. 3204.
The Drug Quality and Security Act Webinar Series details the compliance requirements, timelines and implications for members across the pharmaceutical supply chain. One registration provides links for all on-demand webinar replays.
Webinar Series Events (1 hr each):
WEBINAR 1: H.R. 3204 Regulatory Overview
WEBINAR 2: Manufacturer Focus
WEBINAR 3: Wholesale Distributor Focus
WEBINAR 4: Dispenser Focus
WEBINAR 5: Repackager/3PL Focus
NOTE: TraceLink also has a new DQSA Fundamentals webinar summarizing the regulations and business requirements.
Discussion focuses on unique requirements for each segment and the implications for the entire supply chain:
- Network compliance timelines for all supply chain participants
- Key definitions framing product and transaction requirements
- Serialization requirements for packages, homogeneous cases
- Product tracing (lot-level, unit-level) of transaction history, information and statements
- Requests for information on transaction histories
- Verification of product identity and transaction requirements
- Returns, drop shipments, grandfathering and data retention
- Regulatory and business considerations for implementation
Join us to understand the requirements for your business and help ensure you have the insight, agile track and trace strategy and scalable global IT architecture to meet US and global track and trace requirements.
Register Now - On-Demand!
Date (orig): Oct. 4 - Nov. 1, 2013
Time: 11am EST, (GMT-04:00)
Length: 1 hour. including Q&A
VP of Marketing at TraceLink
The on-demand replay links are sent via email.
Contact us for the webinar slides or to discuss TraceLink's comprehensive compliance solutions for DQSA!
Webinar Series Schedule
(Original presentation date):
Regulatory Overview (10/4)
Manufacturer Requirements (10/11)
Wholesaler Requirements (10/18)
Dispenser Requirements (10/25)
Repackager / 3PL Requirements (11/01)