Validation Requirements Based on ICH Q9

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products) Detail review of Quality Risk Management as Part of Production and

Validation.

Areas Covered in the Webinar:

• Understand why the use of Risk Management in Process Validation is now expected.
• What does the FDA expect for batch conformance prior to, and post, product approval .
• What is the benefit of using the Risk Management approach versus the traditional 3 batch validation approach?
• What does ICH Q9 mean with respect to Quality Risk Management in Validation.
• Learn why the Quality Risk Management approach to Validation will result in less ongoing process support during production.

Who Will Benefit:

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries with daily responsibilities in the:

• Quality Assurance
• Regulatory Affairs
• Compliance Auditing
• Validation
• Manufacturing
• Consultants
• Training
• Quality Control
• Product Submission