- Date:
-
- Seminar
Validierungsbeauftragte/r in der pharmazeutischen Industrie (QV 16)
- Event location:
- Mannheim
- Organizer:
- CONCEPT HEIDELBERG GmbH
Basics/Guidelines
- History of Validation
- Definitions
- Relevant Regulatory Frameworks
- AMWHV, EU-GMP Guidelines, PIC/S, 21 CFR 210/211
- FDA Guidelines and Guides to Inspection of...,
- WHO
Validation Master Plan
- Objective
- Responsibilities and Scope
- Structure and Content
- Extent
- Practical Example
Risk Analysis
- Why is a risk analysis necessary?
- What methods are available for risk analysis?
- Practical Example
Workshop Risk Analysis
In the workshop, device and process FMEA as well as HACCP analysis will be conducted.
In the workshop, device and process FMEA as well as HACCP analysis will be conducted.
Qualification
- URS, DQ, FAT, IQ, SAT, OQ, PQ
- Organization of Qualifications
- Requalification
- Handling of Old Equipment
Validation Documentation
- GMP requirements for creating qualification/validation plans and reports
Workshop Validation Documentation
In the workshop, a document audit of qualification template documents will be carried out, comparable to a GMP inspection.
Computer Validation
Computer Validation
- Factory organization of computer validations
- Risk analysis
- System classifications (GAMP)
- Maintaining the validated state
- Handling changes
- Handling legacy systems
Process Validation
- Prospective, concurrent, retrospective validation
- Continued/Ongoing Process Verification
- Practical Example
Case Studies
Qualification Case Study
Using a newly planned WFI system, all qualification stages up to FDA inspection are covered.
Qualification Case Study
Using a newly planned WFI system, all qualification stages up to FDA inspection are covered.
Validation Case Study
Using a film-coated tablet as an example, the development, scale-up, and validation of the process are demonstrated.
Using a film-coated tablet as an example, the development, scale-up, and validation of the process are demonstrated.
Validation/Qualification Requirements for Active Substance Operations
- Regulatory Frameworks
- GMP requirements for qualification in active substance manufacturing
- GMP requirements for validation in active substance manufacturing
- Retrospective Qualification
- Retrospective Validation
- Practical Examples
Cleaning Validation
- Validation Plan
- Documentation of Personnel and Equipment
- Sampling for Analytics
- Establishment of Limits
- Practical Examples
Change Management
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
