FDA QSR/cGMP Compliance: Auditing

Date: To be confirmed
Instructor: Dr. Mel Dong
Location: To be confirmed
Contact us for more information: bbc@bluebell-consulting.com

This two-day course will focus on how to conduct effective audits of various operations in quality system in accordance with 21 CFR Part 820 with its interpretations to identify the critical deficiencies associated with QSR/cGMP compliance and product quality. Guidances of U.S. FDA and GHTF, e.g. QSIT, will be referenced and attendees will gain practical skills and proven techniques for audits.Although quality and compliance auditing is not specifically required by drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always been in favor of self-audit programs and has issued citations to companies for failing to conduct audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations.

In addition, our seasoned instructors will share the audit experience in multiple facilities of different scales and products. The QSR/cGMP requirements will also be reviewed and discussed.

• Compliance Audit Program: Basic Elements
  • Scope of audit program
  • QSR/cGMP application
  • Audit report security
• Audit References, Tools, Techniques, and Skills
  • QSR/cGMP compliance reference materials
  • Three audit techniques
• General Compliance Auditing
  • Management control
  • Document control
  • Material control
  • Facility and equipment control
  • Production and process control
  • Design control
  • Corrective and preventive actions
• Audit on Qualification and Validation Studies
• QSR Requirements and Audit Focus on Contractors