Next Workshop date: October 22-24, 2013
Workshop space limited to 20 registrants to allow better attendee participation. 
Click Here to be placed on our wait list if you need to get your company's approval first. You may request an invoice.
Register Today Online registration accepts all major credit cards. Select "mail" option if sending payment by check.

Dates
Tuesday Oct. 22 - Thursday Oct. 24, 2013

Location
3138 10th street
Suite 300
Arlington, VA 22201
571-814-3450

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

Registration Fees (hotel accommodations not included)
IPEC Member Companies - $2000
Nonmembers - $2400
Government Rate - $740

Not sure if your company is an IPEC-Americas member?
Click Here

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
3138 10th street
Arlington, VA 22201
Suite 500
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
571-814-3450 or email ipeainc@aol.com

Join our mailing list to receive information on future training opportunities