PBUS - Excipient Risk Analysis and Auditing

Boston, Massachusetts
Tuesday, July 22, 2014
PBUS - Excipient Risk Analysis and Auditing
Tuesday, July 22, 2014 8:00 AM -
Wednesday, July 23, 2014 5:00 PM (Eastern Time)

NSF Health Sciences Pharma Bio Office
129 South Street - 6th Floor
Phone: 857-277-0060
Boston, Massachusetts 02111
United States

Map and Directions

Cost: $1775

Course Content

This course will review recent legislation enacted by key regulatory bodies including EMA, FDA, CFDA, ANVISA to ensure excipients are produced and supplied according to Good Manufacture Practice.  The impact on excipient manufacturers, brokers and distributors will be reviewed along with the expectations of drug product license holders.  This course will explain expectations for excipient risk analysis and how to adapt your company’s Vendor Management Program accordingly.  The pharmaceutical industry often accounts for only a small proportion of an excipient manufacturers volume and often auditors need to work around time constraints.  This course will cover good auditing techniques and strategies to overcome these constraints while meeting your company’s objectives.

What You Will Learn

Recent changes in legislation impacting excipient manufacture and supply:

  • European Falsified Medicines Directive and provision for verifying excipients are produced according to “appropriate GMP”
  • GMPs for excipients recently issued in China and Brazil Effective Application of Risk Analysis:
  • European draft guidance on Excipient Risk Assessments
  • Establishing a risk-based Vendor Management Program Effective Audit Programs for Excipients:
  • Strategies for conducting highly effective audits of excipient manufacturers
  • Auditing techniques for abbreviated audits

Your Tutors: Luba Skibo and Janeen Skutnik


Contact Information

  • Please phone Kate Principe 857-350-4811 or email kprincipe@nsf.org with any questions or need assistance.

Payment Instructions

  • CREDIT CARDS: All credit card information including billing address needs to be entered exactly as shown on the Credit Card statement.

    BY CHECK: Make payable to "NSF Health Sciences LLC" and mail  to us at: NSF Health Sciences LLC, 129 South Street, Boston, MA 02111.

    Bank - JP Morgan Chase, New York, NY
    ABA Number - 021000021
    Account Name - NSF International 790465173
    Swift Code - CHASUS33

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