US Drug Supply Chain Security Act - Serialization & Validation for Track & Trace Compliance 2015

Topics

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

Who should Attend

Attendees from:

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