Training
Training
PHARMACEUTICAL TRAINING
Training related to Pharmaceutical Quality System and Regulatory Guidelines as per attached Table :
TRAINING MODULES OFFERED | |||
---|---|---|---|
SUBJECT | DAYS | SUBJECT | DAYS |
A New Approach to Process Validaon | 02 | Problem Solving & Stascal Tools | 02 |
Cross contaminaon – Sources andPrevenon | 02 | Train the Trainers(Module for technical professionals) | 02 |
Quality Risk Management with stascaland Problem solving tools (ICH Q9) | 02 | Qualificaon of equipment and Instruments | 02 |
Concepts of Good Manufacturing Pracces(ICHQ7 ) | 02 | Design, Qualificaon and Validaon of Purified water system | 02 |
Changes, Deviaons, Failures; Invesgaonand CAPA Management ulizing problem solving tools | 02 | Data Integrity | 01 |
Cleaning Validaon | 02 | Complaint and Recall Management | 01 |
Effecve Change Management System (Inaccordance with EU, WHO and PIC/s) | 02 | Good Documentaon Pracces | 01 |
Comprehensive cGMP Model for 21stcentury | 02 | Conducng Internal Audits | 01 |
Preparaon of SOPsfor Compliance | 02 | Qualify Internal Auditors | 01 |
Filing of Variaon for Approved NDA orANDA | 02 | Fundamental Course on Sterilizaon | 01 |
Implementaon of ISO 9001:2015Standards | 02 | Effecve Process Simulaon Execuon | 01 |
Way to Successfully Face a RegulatoryAudits | 02 | Good Laboratory Pracces | 01 |
Genotoxic Impuries | 02 | Quality by Design | 01 |
Design, Qualificaon, Validaon andMaintenance of HVAC System | 02 | Root Cause Analysis | 01 |
Implementaon of 5S in PharmaceucalIndustries | 02 | Impurity Profile in API and PharmaceucalIngredients (ICH Q3) | 01 |
Development of PM Plan | 01 | Equipment Cricality Analysis | 01 |
Overall Equipment Efficiency (OEE) | 01 | Spare parts Stock Analysis | 01 |
Tracking of Maintenance Performance | 01 | Equipment Failure Analysis | 01 |
Maintenance System and Pracces | 01 | GMP and Hygiene. | 01 |
Good Engineering Pracces. | 01 | Pump and pumping system | 01 |
Role of Engineers in Pharma Industry. | 01 | Scrubber System. | 01 |
Industrial applicaon of Heat Exchanger | 01 | Zero Liquid Discharge | 01 |
Pharmaceucal waste water treatment. | 01 | Different types of Vacuum system | 01 |
Innovaon in HVAC for Pharma Plant | 01 | Future aspect of Reactor Design | 01 |
Energy Conservaon measures required forPharmaceucal Industries. | 02 | Regulatory Compliance in Crical Pharmaceucal Areas. | 01 |
GAP ANALYSIS
- Gap Analysis in accordance with Global Regulatory Requirements.
- Gap analyses are conducted by experienced experts to identify deficiencies in the Quality System by auditing documents and records of all departments.
- Also, services are extended to plan and verify CAPA,
– To upgrade Quality System
– Prior to the regulatory audit
VERTICAL AUDITS
- Vertical Audits are conducted to address failures like OOS, major deviations, or critical changes.
We’re Working With