21 CFR Part 11: Auditing for Part 11 Compliance 2012

Key Topics

• Detailed description of HOW TO prepare internal and external audits schedules to include Part 11 audits
• Short and quick overview of the Part 11 regulation
• Execution of the audits
• How to prepare for a specific audit that includes Part 11 regulation
• Training requirements; good practices
• Follow up (difference from other quality audits)
• Warning letters examples
• Commonly asked questions
• The focus is on DIFFERENCE between regular QMS audits in audits when Part 11 is in scope of the audit - from auditors
• What the future holds when it comes to Part 11
• Training
• Regulations
• Execution
• Preparation
• Follow up and other standpoints

Who should Attend

Quality Engineers, Quality Managers, Internal and External Auditors, Small Business Owners, FDA Inspectors, Management Reps and Consultants.