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.
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