Solution preparation and Filtration
Module Lenght
from 1 day and a half to 2 days
Agenda
- Regulatory aspect from International Agencies
- Technical Background from cGEP (Good Engineering Procedures)
- Validation Life Cycle
- Design Qualification
- Installation Qualification
- Operational Qualification
- Calibration
- Performance Qualification
- Operational and Maintenance Aspects
Target audience
- Engineering
- Validation
- Maintenance
- Manufacturing
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
- EU cGMP – The rules governing medicinal products in the European Union “Good manufacturing practices”
- PIC/S GMP
- WHO GMP
- USA GMP – CFR21 Parts 210,211
- ISPE – Baseline Vol. 2 “Oral solid dosage forms”
- ISPE – Baseline Vol. 3 “Sterile Products Manufacturing Facilities”
- ISPE – Baseline Vol. 7 “Risk-Based Manufacture of Pharmaceutical Products”
- FDA Guidance for Industry “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice”
- PDA – TR 61 “Steam in Place”
- EMA ICH Q7A “Note for Guidance on GMP for Active Pharmaceutical Ingredients”
- FDA ICH Q7A “GMP Guidance for Active Pharmaceutical Ingredients”
- ASME BPE 2014 Bioprocessing Equipment
Number of trainers
One
Tailoring option available
No
Final evaluation quiz
Yes