For more information contact info@ipeainc.com
Training and Workshops


Excipient GMP Auditing Workshop

October 12-14, 2010

Location
IPEA and IPEC-Americas Main Offices

1655 N. Fort Myer Drive
Arlington, VA 22209
Phone: 703-351-5266

Dates
Tuesday
October 12-Thursday October 14, 2010

Registration Fees
IPEC Member Companies - $1850.00
Nonmembers - $2250.00
Government Rate - $600

Click here for Hotel Information
Hotel fees are not included.
Questions please contact IPEA
703-351-5266 or email ipeainc@aol.com


Workshop Information:

This workshop for makers and users trains auditors in assessing excipient manufacturers conformance to appropriate GMP requirements.

This workshop is designed to train personnel to conduct audits of excipient facilities.

It includes the topics covered in the workshop Auditing the Excipient Manufacturer
below plus:

  • 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
  • Hands-On Mock GMP Audit

Auditing the Excipient Manufacturer
This workshop is meant for personnel already trained to perform audits but who are unfamiliar with auditing excipient manufacturers. It includes discussion of the following topics:

  • Qualifying an Excipient Supplier
  • Regulatory Requirements
  • Uniqueness of Excipients
  • Where does GMP start?
  • Assessing Excipient Supplier
  • GMP Conformance
  • Joint IPEC-PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients
  • Management Responsibility
  • Resource Management
  • Product Realization Measurement
  • Analysis and Improvement
  • General Auditing Considerations

IPEA workshops are limited to 20 participants.
To be notified first before the next workshop,
Click here to contact IPEA