GMP Basic Training Qualification and Validation
Target group
This e-Learning course addresses beginners involved in process validation and equipment qualification activities such as subject matter experts for validation, employees quality assurance, engineering, production etc.
Duration
approx. 3 hours
Costs
€ 590,- plus VAT
Any question?
Phone: +49 (0)6221 / 84 44 0
E-mail: info (at) concept-heidelberg.de
Objectives
You will learn about the EU and FDA requirements regarding Process Validation and Equipment Qualification. There will be also short overviews about Cleaning Validation and the Validation of Computerised Systems.
Programme
Regulatory Requirements
- EU GMP guideline and annexes
- PIC/S guidelines
- FDA 21 CFR 210/211 and Guidances for Industry/Guide to inspection of…
- WHO
- Validation Master Plan
- Requirements according Annex 15
Risk Assessment
- Why is risk assessment necessary?
- ICH Q9 revision 1
- Risk assessment techniques and tools
- Case study
Qualification
- Annex 15 requirements
- FDA requirements
- URS, FDS, DQ, FAT, IQ, SAT, OQ, PQ – how the stages fit together
- How to handle qualification logistics?
- Re-qualification – when, what, how often?
- Qualification of equipment in use
- ASTM 2500 vs Annex 15
- When does calibration happen?
Process Validation
- The validation life cycle
- Prospective vs concurrent validation
- Are 3 runs still state of the art?
- What does Hybrid Approach mean?
- Revalidation vs. Continued Process Verification and Ongoing Process Verification
- Similarities/differences between Process Validation expectations in US and EU
- Overview: Cleaning Validation
- Overview: Validation of computerised Systems
Analytical Method Validation
- ICH Q2 R1
- Verification of compendial methods
- Method transfer
- Recap of the most important analytical Parameters
Change Control
- GMP vs Marketing Authorisation – an important distinction during Change Control
- The Change Control Process
- Who is involved?
- Like-for-like changes
