Validation Requirements Based on ICH Q9

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

Instructor Profile:

Jamie Jamshidi, Biotech-Pharmaceutical Quality & Regulatory Advisor has over 27 years of industry experience, including small molecules and large molecule biologicals.

Jamie has a broad understanding of the entire drug development process for both large molecule proteins and small molecules. She has extensive knowledge of U.S. Regulatory Filings through product life cycle, FDA Current Good Manufacturing Practices (CGMP), Current Good Laboratory Practices (CGLP) and Current Good Clinical Practices (CGCP), European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives, and World Health Organization (WHO) regulations.

Jamie also has extensive experience in the development and commercialization of pharmaceuticals and biotechnology at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. She has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities and conferences globally. She is well known in bio/pharmaceutical industry for her passion and respect for laws and regulations in ensuring product quality.

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