a specialized engineering and quality assurance course designed to teach the compliance, design, operation, and qualification of critical systems used in drug manufacturing. It focuses on maintaining a sterile, current Good Manufacturing Practice (cGMP)-compliant environment to ensure patient safety and product quality
Created by Dr. YASSER MEKKY
EN/AR [Auto]
Join Now| # | Content |
|---|---|
| 1 | Module 1: Introduction to Pharmaceutical Facilities & Regulations |
| 2 | Module 2: Core Pharmaceutical Manufacturing Equipment |
| 3 | Module 3: Critical Clean Utilities |
| 4 | Module 4: Commissioning, Qualification, and Validation (CQV) |
| 5 | Module 5: Technical Lifecycle Management & QA Systems |
| # | Outcomes |
|---|---|
| Identify and specify critical pharmaceutical equipment and clean utility architectures. | |
| Apply cGMP regulations and ISPE Good Practice Guidelines to system operations. | |
| Draft and execute validation protocols (IQ/OQ/PQ) for equipment and clean utilities. | |
| Manage technical quality systems, including change control, deviations, and CAPA. | |
| Implement risk-based approaches (ICH Q9) to maintain systems in a qualified state. |
| # | Participants |
|---|---|
| 1 |
E
Engineers (Chemical, Mechanical, and Pharmaceutical Process Engineers).
|
| 2 |
Q
QA/QC Specialists and Validation Technicians.
|
| 3 |
F
Facilities and Plant Managers overseeing maintenance and utilities.
|
| 4 |
S
STEM Graduates seeking entry-level validation or operations roles.
|
601, El Horeya St,7th floor Zizinia, Alexandria, Egypt
(+2) 01099 770 699
dr.yassermekky@charismaqs.com
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