- Datum:
-
- Webinar
Validation/Qualification for Beginners - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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
Q & A Sessions
Two Q &A sessions ensure interaction and that your questions are answered.
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
