Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation) (Recorded)

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.

This seminar will provide a channel to enhance understanding of the utilization of process validation and Phase 1, 2 and 3, where their guidance blend and where they remain distinct. In particular, Stage 3 continued process verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.

Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.

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?
• 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 Guidance blend and where they remain distinct. In particular, Stage 3.

SEMINAR 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 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 Phase 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 to FDA’s Process Validation Guidance.