- Date:
-
- Webinar
Validation Officer in the Pharmaceutical Industry (QV 16) - Live Online Seminar
- Event location:
- online
- Organizer:
- CONCEPT HEIDELBERG GmbH
Greeting and Introduction
- Introduction to the course
- Explanation of the Internet examination
Fundamentals/Guidelines
- History of validation
- Definitions
- Relevant regulations
- AMWHV, EU-GMP Guidelines, PIC/S, 21 CFR 210/211
- FDA Guidelines and Guides to Inspection of...,
- WHO
Risk Management
- The risk management process according to ICH Q9
- Why is a risk analysis necessary?
- What methods are available for risk analysis?
- Practical example
Validation Master Plan
- Goal
- Responsibilities and scope
- Structure and content
- Extent
Qualification
- URS, DQ, FAT, IQ, SAT, OQ, PQ
- Organization of qualifications
- Requalification
- Handling of legacy systems
Day 2
Qualification Case Study
- Project planning of water system
- The design phase: risk analysis, URS, DQ
- IQ, OQ, PQ
- Inspection experiences
Process Validation
- EU vs USA
- The link to approval
- Prospective, concurrent, validation
- Continued/Ongoing Process Verification
- Tips and tricks from practice
Process Validation Case Study
- Quality Target Product Profile (QTPP)
- Initial risk analysis
- Development of a solid dosage form (CQAs)
- Final risk analysis
- The process validation
- Validation plan and report
Computer Validation
- In-house organization of computer validations
- Risk analysis
- System classifications (GAMP)
- Maintaining the validated state
- Handling changes
- Handling legacy systems
Qualification Case Study
Using a newly planned WFI system, all qualification stages up to FDA inspection are covered.
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.
Day 3
Validation/Qualification Requirements for Active Substance Operations
- Regulations
- 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
- Changes, deviations, and trials
- Regulatory relevance of changes
- Appropriate scope of change management in validation sector
- Implementation into 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/
