Falsified Medicines and Drug Supply Chain Security

• OVERVIEW

This 60-minute webinar course answers the following questions:

• What are the FDA requirements for applying new lot item identifiers in drug GMP manufacturing?
• When do FDA serialization compliance deadlines occur?
• Why was this new legislation passed?
• Who will be impacted by this regulation?
• How can companies prepare for compliance with this?

 

• LEARNING OBJECTIVES

 

• Participants will learn the following:
• Why this new legislation has been enacted?
• The major elements of the Drug Supply Chain Security Act (DSCSA)
• The type of transaction records expected for compliance
• Computer technology challenge to achieve compliance
• Verification of suspect product and validation of distribution systems
• The roles and responsibilities of the manufacturer and other supply chain vendors

 

• WHY SHOULD YOU ATTEND
• On January 1, 2015, the US Drug Quality and Security Act (DQSA) went into effect. Part I of this Act is about Drug Compounding and Part II is about Drug Supply Chain Security (DSCS). This act established national standards for pharmaceutical distribution supply chain practices to track and trace drug product from manufacturer through wholesalers and distributors to dispensers and back. Compliance to these new standards is mandatory and requires specific computerized transaction records to be generated and kept for at least six years. Supply chain managers need to know this regulation so that they can plan how to implement a cost effective compliance approach to the new requirement for serialization of product lot items.
• AREAS COVERED

This session will cover the following topics:

• The major elements of the Drug Supply Chain Security Act (DSCSA)
• The type of transaction records expected for compliance
• The roles and responsibilities of the manufacturer and other supply chain vendors
• Definitions of key terms
• The role of technology and computer systems for compliance
• Regulatory timeline for full compliance
• Unique product identifier and Product lot traceability requirements
• Item level serialization within Product lot

 

• WHO WILL BENEFIT?

 

• Quality Assurance (QA Director, Analyst, Associate)
• Records Management (Batch Records Manager)
• Regulatory affairs (RA Director, Records Compliance staff)
• IT Dept. (CIO, IT Director, IT analyst, IT staff)
• GXP compliance auditors
• Manufacturing, warehousing, distribution services for prescription drug products

 

• SPEAKER

Dr. Teri Stokes worked as a medical technologist in hospitals, researches, and central laboratories. Teri's transition to computers came from troubleshooting systems reporting laboratory results. She joined Digital Equipment Corporation (DEC) for a 16-year career focused on pharmaceutical computer solutions.

Others Details

For more detail please click on this below link: http://bit.ly/2n8WKHS Email: [email protected] Tel: +1-(510)-868-1040