Tuesday April 5-Thursday April 7, 2011
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.
Three day 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
Hands-On Mock GMP Audit
Workshop Content
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
Link:http://www.ipeainc.com/auditingworkshop11.htm
SOURCE:IPEC 