- Date:
-
- Seminar
Validierungsbeauftragte/r in der pharmazeutischen Industrie (QV 16)
- Event location:
- Hamburg
- 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
The workshop will conduct equipment and process FMEA as well as a HACCP analysis.
The workshop will conduct equipment and process FMEA as well as a HACCP analysis.
Qualification
- URS, DQ, FAT, IQ, SAT, OQ, PQ
- Organization of Qualifications
- Requalification
- Handling of Old Systems
Validation Documentation
- GMP requirements for creating qualification/validation plans and reports
Workshop Validation Documentation
The workshop will perform a document audit of qualification template documents, comparable to a GMP inspection.
Computer Validation
Computer Validation
- In-house organization of computer validations
- Risk analysis
- System classifications (GAMP)
- Maintaining the validated state
- Handling changes
- Handling of 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 presented.
Using a film-coated tablet as an example, the development, scale-up, and validation of the process are presented.
Validation/Qualification Requirements for Active Pharmaceutical Ingredient Operations
- Regulatory Frameworks
- GMP requirements for qualification in the active ingredient sector
- GMP requirements for validation in the active ingredient sector
- Retrospective Qualification
- Retrospective Validation
- Practical Examples
Cleaning Validation
- Validation Plan
- Documentation of Personnel and Equipment
- Sampling for Analytics
- Establishing Limits
- Practical Examples
Change Management
- Changes, Deviations, and Trials
- Regulatory Relevance of Changes
- Appropriate Scope of Change Management in Validation
- Implementation in Practice
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/
