For more information contact info@ipeainc.com
About the Workshop

About the Workshop | Who Should Attend | Program | Workshop Leaders |
Hotel and Registration Information | Online Registration

Three-Day Auditing Workshop
November 14-16, 2006

Registration Fees
Three-Day Workshop
Employees of
IPEC-Americas
Member Companies
$1,850.00
Nonmembers
$2,250.00

Credit cards not accepted.
Check payment please.


8:00-9:00am Registration
8:30-9:00am Continental Breakfast
9:00-5:00pm Workshop Session


Workshop Content

A comprehensive three-day workshop in excipient auditing for makers and users. Training will analyze the essential elements of excipient good manufacturing practice for materials intended for use in pharmaceuticals, dietary supplements, food or as industrial chemicals and explains how the applicable product standards differ.

The workshop will focus on excipient GMP compliance and attendees will learn auditing techniques, report writing, observation classification, etc. that relate to the manufacture of excipient ingredients. The workshop contains exercises to hone observation skills through participation in a hands-on mock excipient GMP audit. Participants will gain a thorough understanding of risk-based excipient auditing and learn how to assess whether an excipient GMP quality system can achieve a satisfactory level of compliance. Finally, attendees will learn how to differentiate the requirements for excipient manufacture from those of APIs.

Participants who complete the course will have learned how to plan, conduct and document excipient manufacturing facilities for conformance to excipient GMP standards as listed in <1078> of USP/NF and in IPEC GMP Guidance.

Click here to find out more

Crown Plaza Philadelphia Center City Hotel

1800 Market Street
Philadelphia, Pa 19103
Tel: 215-561-7500
Fax: 215-561-4484





Course 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
  • Differences & Similarities: IPEC/PQG GMP Guide (2006)
    and IPEC Guide (2001)
  • Hands-On Mock GMP Audit

Workshop Leaders


Arthur Falk, Ph.D, MBA. - IPEC-Americas Chairman
Irwin B. Silverstein, Ph.D - IPEA Chief Operating Officer
 
*** Register early! ***

Space limited to 20 registrants to allow better attendee participation

 

 

 

 

 

 

 

 

 

 


 
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