Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

Common questions asked by the users of Process Validation include;

• How does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge?
• Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated?
• To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3?
• Does it follow along or with Stage 3? Questions that exist include how one manages special situations to include viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests to include DNA and host cell protein.

These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3.

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

Learning Objectives:

Why these FDA Guidance/EU Guidelines for Industry - Process Validation is so important to the pharmaceutical and biotechnology industry.

• What FDA segments are included and excluded within the "NEW" Process Validation.
• Where does the Process Validation commence.
• What are the Three Stages and Where Do They Apply within the NEW Process Validation.
• How Stage 1 integrates with Phase 1.
• The Validation approaches that are included within this Guidance document.
• The Statutory and Regulatory Requirements for Process Validation.
• An Introduction tPhase 1 Guidance for Industry and Its Application within the "NEW" Process Validation.
• The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required.
• General Considerations for Process Validation - Stage 2 Process Qualification.
• Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.
• General Considerations for Process Validation - Stage 3 Continued Process Verification.
• A Review of EU Annex 15 and its Comparison tFDA's Process Validation Guidance.

Who Will Benefit:

Those who will benefit from this seminar include

• Product Development
• Project Management
• Regulatory Compliance
• Quality Assurance
• Quality Control
• Manufacturing and Facilities professionals who are required to develop and participate in understanding issues surrounding Process Validation.