Oct. 17-19 Excipient GMP Compliance Workshop for Auditors and Auditees

Save the Dates: Tuesday Oct 17 - Thursday Oct 19, 2017

Location
Radnor, PA

Workshop space limited to 20 registrants to allow better attendee participation. 

Email us to be placed on waiting list (Registration to be announced)
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Fees (hotel accommodations not included)
IPEC Member Companies - $1850
Nonmembers - $2250
Government Rate - $740


Who Should Attend
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Description
This is a comprehensive workshop in excipient compliance for both makers and users. Training includes analyzing the essential elements of excipient good manufacturing practice for materials intended for use in pharmaceuticals or dietary supplements.

Training Objectives
After completing this hands-on, interactive workshop:

  • All participants will be able to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP expectations.
  • Excipient makers will be able to assess their conformance to NSF/IPEC/ANSI 363 and remediate any gaps.
  • Excipient users will be able to:
    • assess their suppliers for adequate conformance to NSF/IPEC/ANSI 363.
    • address the EU Falsified Medicines Directive (FMD) Guideline on the formalized risk assessment for determining the appropriate good manufacturing practice for excipients of medicinal products for human use.

Presenters
Learn firsthand from subject matter experts who helped develop the ANSI standard: Irwin B. Silverstein, Ph.D., CQA, and Sidney A. Goode Pharm D, RPh. Read Bios

Overview

  • Assessing GMPs for Excipient Manufacture
  • Where GMPs Begin
  • Audit Planning
  • Pre-audit Questionnaires
  • Alternative Audit Approaches
  • Audit Checklists & Techniques
  • Necessary Auditing Interpersonal Skills
  • Defining Pertinent Audit Issues In Observations
  • Writing & Rating Observations
  • Excipient Manufacture Requirements vs. APIs
  • Review of the NSF/IPEC/ANSI-363 Excipient GMP Standard
  • Hands-On Mock GMP Audit

Cancellation and Travel Expense Policy:
Must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Workshops
3138 10th street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees (less 5% non-refundable service fee) are refundable if cancellation is received at least three weeks (21 calendar days) prior to workshop start date (less service fees). Cancellations received thereafter are non-refundable. Registrations are transferable to other company representatives if requested via mail or e-mail up to 5 business days before the workshop.

IPEC-AMERICAS IS NOT RESPONSIBLE FOR ANY TRAVEL EXPENSES OR FEES INCURRED BY PARTICIPANTS. WORKSHOPS WILL BE CONFIRMED NO LATER THAN 3 WEEKS PRIOR TO SCHEDULED START DATE.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email

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