21 CFR Part 11 - Complete Manual for Compliance and Success 2012

21 CFR Part 11 - Complete Manual for Compliance and Success 2012 is a webinar that covers topics such as:

• Internal and External Auditing for Part 11 Compliance
• How to prepare and host FDA inspection when Part 11 is in scope
• Overview and Correlation of Part 11 with other regulations
• Audit Trails: Ins and Outs
• Sample Audit Questions
• Trends, Warning Letters, Advantages and Disadvantages of Compliance/Use of Part 11

21 CFR Part 11 - Complete Manual for Compliance and Success 2012 brings together Regulatory Affairs, IT/ IS, Quality Engineers, Product development engineers, Internal and External Quality Auditors, Quality Managers, CAPA investigators, Management Representatives and Project managers.