ComplianceOnline

Supplier Qualification and Oversight: How to Cope with a Global Supply Chain

Instructor: Paula Shadle
Product ID: 701507
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This supplier qualification training/Webinar will discuss on strategy to apply to QC testing and QA oversight, that helps to assure suitable quality of raw materials/excipients, and how to detecting fraud.

Why Should You Attend:
Global sourcing of raw materials and excipients, undertaken to reduce cost, has opened up the supply chain to increased risks and limited the ability to patrol it. This webinar will suggest a strategy to assess risk, as well as tactics to use in audits and supplier interactions. Should you do more testing? If so, what methods? More auditing? Where do you audit-- the basic manufacturer, the re-packager, or the vendor you purchase from? How does this potential expansion of due diligence get achieved when there is relentless cost pressure on your business?

Find out whether your audits and surveys actually help you to detect or prevent unsuitable materials from entering your product stream. Have you asked whether the routine QC testing, qualification 'full' testing, and other measures also include a look at intentional and unintentional adulteration? -About 100 people died after receiving heparin that was tainted; Many deaths have occurred in several separate events where diethylene glycol entered medicines; As a pharmaceutical firm, or a supplier of excipients, you are required to assure the traceability and suitability of all ingredients.

Areas Covered in the seminar:

  • A strategy to apply to QC testing and QA oversight, that helps to assure suitable quality of raw materials/excipients, and some tips on detecting fraud.
  • Assessing relative risks of different materials.
  • How to qualify high-risk materials with suitable QC testing.
  • Approaches to auditing the supply chain.
  • What does supplier qualification really mean?
  • What not to do.
  • How to train auditors and supply chain professionals.

Who will benefit:

This webinar will help pharmaceutical, biologics, and nutraceuticals firms learn how to mitigate their risk. Excipient suppliers can gain insight into their customers' requirements, and explore their supply chains for risk and risk mitigation potential.

  • QA, QC, Supply chain management, Procurement
  • Manager, Director, VP level
  • QA auditors
  • Methods development and QC

Instructor Profile:
Paula Shadle, Ph.D., a quality and process development consultant has over 20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, over 45 publications and 4 process patents. Is a member of the Parenteral Drug Association, the American Chemical Society, the Association for Women in Science, and the California Separations Society (CaSSS). Dr. Shadle has provided GMP training for numerous firms as well as the University of Wisconsin, and gives frequent audio seminars.

Dr. Shadle received her B.S. and Ph.D. in biochemistry at the University of California and postdoctoral training at the Max-Planck Institute in Germany. She held technical and quality control/assurance positions of increasing responsibility at Chiron Corporation, Scios Inc., GlaxoSmithKline plc, and Bayer Corporation before founding Shadle Consulting in 2001.

Shadle Consulting offers consulting services for biopharmaceutical firms in process development, CMC, and quality systems. Services provided include QA audits, GMP training, QC laboratories, and IND/BLA support. Experienced with clinical trials production, process validation, and more.

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