*hotel fees (not included)

Credit cards accepted.


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

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