ComplianceOnline

Securing your international supply chain:What heparin and DEG have to teach us

Instructor: Paula Shadle
Product ID: 700905
  • Duration: 60 Min

recorded version

$199.00
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Training CD

$450.00
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This presentation reviews case studies and describes actions that your firm should take promptly.

Description

A combination of analytical methods, tamper-resistant packaging, and tracing the supply chain are needed.

Recent adverse events in the US , Europe , and other countries indicate that worldwide sourcing of excipients and APIs requires constant vigilance and active oversight. Although several recent events involve ingredients sourced from China , history shows that pharmaceutical firms must assure the safety and security of ingredients sourced in all areas of the world. This presentation reviews case studies and describes actions that your firm should take promptly. Merely meeting minimum regulatory requirements may not be adequate. A combination of analytical methods, tamper-resistant packaging, and tracing the supply chain are needed.

Areas Covered in the seminar:

  • Adulterated API: Heparin related deaths and Baxter’s recall of 2008.
  • Pet food and melamine (2007).
  • Cough syrup: 1937 and 2002.
  • Root cause analysis.
  • Steps toward improved oversight.
  • Recent actions by governments, Congress, suppliers, and pharmaceutical manufacturers.

Who will benefit:

  • Executive management at pharmaceutical, API, and raw materials manufacturers
  • QA, QC, and Manufacturing managers
  • Purchasing and supply chain managers
  • Consultants
  • Quality auditors
  • Process development scientists

Instructor Profile

Paula Shadle, Ph.D., is the founder of Shadle Consulting, a firm that specializes in quality systems and process development for biopharmaceuticals. Dr. Shadle has over 20 years of hands-on and executive experience in biopharmaceutical process development and quality at firms including Chiron, Scios, GSK and Bayer. She has published over 40 publications and is co-inventor on 4 process patents. Dr. Shadle holds a Ph.D. degree in biochemistry from the University of California, and two years’ postdoctoral experience at the Max-Planck-Institute. She is on the boards of the West Coast Chapter, PDA, and the East Bay Chapter, AWIS, and on the editorial board of BioPharm International.

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