Registration Form
Register early! Space limited to 20 registrants to allow better attendee participation.

Dates
Tuesday March 13 -Thursday March 15, 2012

Location
IPEA and IPEC-Americas Main Offices
1655 N. Fort Myer Drive
Arlington, VA 22209
Phone: 703-351-5266

Schedule
8:00am Registration first day
8:30-4:30pm Workshop Sessions 

Registration Fees
IPEC Member Companies - $1850
Nonmembers - $2250
Government Rate - $600

Not sure if your company is an IPEC-Americas member?
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Three day Workshop Content

A comprehensive 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 or dietary supplements.

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 including 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. Hear the latest concerning Excipient GMP Conformance Certification.

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

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
• Hands-On Mock GMP Audit

Outline

DAY 1

• The Different Issues Associated with Excipient GMP Auditing
• Audit Planning & Use of Pre-Questionnaires
• Alternate Approaches to On-Site Auditing
• Interpersonal Skills Associated with Auditing
• Auditing Techniques
• Recording Observations

DAY 2

• Comprehensive Discussion & Review of Excipient Auditing Checklists
  
  • Applying audit techniques to GMP checklist categories
  • Typical audit observations for checklist categories
• Rating Audit Observations

DAY 3

• Hands-on Mock GMP Audit
• Audit Observations: writing & rating workshop
• Presentations and Feedback from Audit Results
• Locating Resources on Excipient GMPs & Auditing
• Excipients vs. APIs
   

Hotel fees are not included. Attendees are responsible for accommodations.

Cancellations:
Cancellations for this workshop must be made in writing and can be mailed, e-mailed or faxed to:

IPEA Workshops
1655 N. Ft. Myer Drive, Suite 700
Arlington, VA 22209
Fax: 703-525-5157
E-mail: ipeainc@aol.com

Registration fees are refundable if cancellation is received two weeks prior to workshop start date. Cancellations received thereafter are non-refundable. Registrations are transferable to other company representatives at any time.

Questions?
Please contact IPEA
703-351-5266 or email ipeainc@aol.com

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