About The Course:
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:
|Lecture 1: Process Validation – Overview|
- Introduction, Goals and Objectives, Definitions
- Its Importance within the Industry
Lecture 2: Phases and Stages
- Interaction of the Three Stages with Process Validation
- How the two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3)
- Where do they merge?
- Do they exist independently of each other?
- Do they complement each other to enhance, build and provide a product?
Lecture 3: Phase 1, 2 and 3
- Validation Approaches, cGMPs in Clinical Supply
- Manufacture, Special Manufacturing Situations within Phase 1
- The Requirements of Phase 1 Investigational Drug Requirements
- Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
|Lecture 4: Stages 2 and 3|
- General Considerations for Process Validation – Stage 2 Process Qualifications
- Special Considerations for Process Validation – Stage 2
- General Considerations for Process Validation – Stage 3 Continued Process Verification
Lecture 5: EU Annex 15
- A Review of EU Annex 15
- Comparison to FDA’s Process Validation Guidance
Lecture 6: Process Performance Qualification (PPQ) Batches
- Concurrent Release of PPQ Batches
- Role of SOP in the company QM System
- How to deal with the established 3 batch approach?
Lecture 7: Analytical Methodology and Process Validation and Warning Letter examples
Who Should Attend:
Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.