New York, NY, June 28, 2014 --(PR.com
)-- The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Greg Page, Life Sciences Practice Head, Deloitte Consulting LLP will speak at the Knowledge Group’s webcast entitled: “Exploring the Drug Supply Chain Security Act (DSCSA) and its Impact to Drug Manufacturers, Wholesalers, and Pharmacies.” This event is scheduled for August 11, 2014 from 12:00pm – 2:00pm (ET).
For further details, please visit: http://theknowledgegroup.org/event_name/the-drug-quality-and-security-act-hr-3204-implications-for-drug-manufacturerspharmacies-and-healthcare-live-webcast/
About Greg Page, PhD in Microbiology,
Greg has over 25 years experience in both the Pharmaceutical and Biotech Life Science industries focusing on Quality Systems, Validation and FDA Regulatory Compliance. He has extensive experience in new business/product development and QC/QA/RA issues.
Prior to re-joining Deloitte Consulting from Navigant Consulting (where he was a Managing Director in the Life Sciences Regulatory practice), Greg was the FDA Practice Leader for Deloitte & Touche’s LS Healthcare Regulatory Practice.
Greg has held industrial management positions at the Director and Vice President level, in such companies as Hoechst (now Aventis), BASF, Bayer, the NY Blood Center/Melville Biologics and VI Technologies.
Dr. Page has extensive FDA audit experience (annual audits, licensing inspections & product meetings) and 483/warning letter/consent decree response and remediation program development. He has led a number of compliance risk assessment and remediation projects for many major pharmaceutical, biotech and medical device companies.
On November 2013, President Obama signed into law The Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). DSCSA authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, adulterated, and diverted products. The law replaces State level e-Pedigree regulations.
Title I of DQSA establishes Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers – large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
Title II of DQSA known as DSCSA paves the way for an electronic tracking system to prevent counterfeited or stolen prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to track serialized medicines from manufacturing facilities to pharmacies. Pharmaceutical wholesale licensing standards, transaction verification, and lot -level tracking, requirements come into effect as early as Jan 1, 2015.
This webinar will address some important issues regarding the new law:
− DSCSA Regulatory Overview
− The Manufacturer and DSCSA
− Wholesale Distributor and DSCSA
− Dispenser Focus and DSCSA
− Re-packager / 3PL and DSCSA
− Regulatory and business implementation issues
− Key definitions for product and transaction requirements
− Serialization requirements for packages
− Product tracing (lot and unit level) of transaction history, statements, and information
− Requests for information on transaction histories
− Verification of product identity and transaction requirements
− Data retention, returns, drop shipments, grandfathering
− Network compliance timelines for supply chain participants
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Group, LLC was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register to an event, please visit: http://theknowledgegroup.org/