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Hotel and Registration Information | Half-Day Registration Form (pdf) | Full-Day Registration Form (pdf)

Half-Day Excipient GMP Auditing Workshop A half-day workshop that explores the auditing of excipient manufacturing sites for compliance with applicable GMP standards. Monday, February 28, 2005 8:00-8:30am Check in and Registration 8:30-12:00 Workshop Session Workshop Content Uniqueness of Excipient Ingredients Assessing GMP Compliance Excipient Auditing USP Excipient GMP Guideline Compliance Requirements Common Site Deficiencies *** Workshop space limited to first 30 registrants*** Click here to find out more

Key Bridge Marriott 1401 Lee Highway Arlington, Virginia 22209 Tel: 703-524-6400 Fax: 703-524-8964

Full-Day Excipient GMP Auditing Workshop- Confirmed!
Workshop date is confirmed for March 2, 2005. Deadline for registration discount of $50 has been extended to January 24. This will be a full-day comprehensive workshop devoted to excipient GMP auditing techniques. It is intended for pharmaceutical and chemical company auditors who assess GMP compliance practices of excipient manufacturers. The workshop will conclude with a review of compliance issues and their potential impact to satisfactory GMP compliance.

Wednesday, March 2, 2005
8:00-8:30am Check in and Registration
8:30-4:30pm Workshop Session

Workshop Content

• Uniqueness of Excipient Ingredients
  
• Excipient GMP Compliance
  o IPEC Excipient GMPs
  o Comparison of Applicable Excipient cGMP Requirements to ISO 9001
  o Comparison of Excipient cGMP to Q7a and 21CFR211
  o Application of Excipient cGMP to Distribution Practices
  
• Assessing GMP Compliance
  o Audits
  o Questionnaires
  o Assessing a Manufacturer Compliant with Applicable Food GMP Regulations
  
• GMP Auditing Considerations
  o Full Excipient Auditing
  o Risk Based Excipient Auditing
  
• Excipient Audit Expectations
  o Common Deficiencies
  o Qualification/Validation
  o Change Management and Significant Change Notification
  
• Compliance Consideration
  o Top Ten GMP Compliance List
  o Risk of Contamination
  o Excipient COA

Click here to find out more