21 CFR Part 11 and Risk Assessment – Avoid Warning Letters and Reduce Costs

This 2-day Seminar on 21 CFR Part 11 and Risk Assessment will help you get completely familiar with the FDA – compliant implementation of 21 CFR Part 11 requirements applicable to the regulated industry.

Our instructor - Mr. KR Vaghela, will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation.

Areas covered:

• 21 CFR Part 11 Compliance
• Key Requirements of Part 11 & Annex 11
• Learning from Recent Warning Letters
• Computer System Validation
• Achieving Data Integrity
• Meeting Data Integrity Regulations
• Risk Assessment
• Risk Based Validation
• VMP & Design Specifications
• SOPs
• Case Studies and more

A must attend seminar for professionals in:

• Pharmaceutical Development Companies
• Quality Control Laboratories Companies
• Quality Departments of API Manufacturers
• Quality Departments of Finished Product Manufacturers
• Contract Laboratories
• Clinical Research Organisations

Registrations are accepted through the website directly or you may contact our sales and support team to sign up via check or direct deposit.