Falsified Medicines and Drug Supply Chain Security

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Presented By 247compliance

Tuesday, October 8th at 1:00pm EST

Online sale ends: 10/08/19 at 12:00pm EST

247compliance

2035 Sunset Lake, RoadSuite B-2, Newark, Delaware - 19702

Online, DE 19702

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Talent

Teri Stokes

Description

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. Based in Basel, Switzerland 1990-1995, she developed DEC's computer validation consulting practice for customers across Europe and in Japan with a focus on reality-based compliance to global good practice (GCP, GLP, GMP) regulations.

For more detail please click on this below link:

http://bit.ly/2nNQntY

Email: support@247compliance.com

Tel: +1-(510)-868-1040

Presented By

Time

1:00pm to 2:30pm
Doors open at 1:00pm

Price

General Admission: $199.00

Age

All Ages

Venue

247compliance<br> 2035 Sunset Lake, RoadSuite B-2, Newark, Delaware - 19702<br> Online, 19702

Info Line

+1-(510)-868-1040