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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.
pharmaceutical training

Faqs

What kind of training programs does PD-VD offer?

PD-VD provides training focused on quality assurance systems for pharmaceuticals and regulations. They cover topics including the validation process, GMP, risk management audits, as well as documentation procedures that are relevant to industry regulation.

Who usually attends these training sessions?

These training sessions can be used by technical experts and engineers, as well as quality teams and compliance professionals who work in the pharmaceutical or closely related fields. Certain modules can even help attendees to mentor others within their companies.

What topics are included in the training modules?

The topics range from process validation, contamination prevention, and equipment certification to data integrity, complaint processing, internal audits, and HVAC verification. This list also includes GMP principles and quality risk management.

How long does a typical training module take?

Most modules run for one or two days, depending on the subject. Shorter sessions focus on targeted skills, while longer ones explore technical or compliance with heavy topics in depth.

Does the training address regulatory compliance?

Yes. Many modules align with global expectations such as GMP practices and international quality guidelines. The content prepares participants to handle inspections, documentation standards, and regulatory audits.

Can companies request training for specific operational needs?

Organizations can use these sessions to strengthen internal systems, address compliance gaps, or prepare for regulatory reviews. The training works as practical support for quality improvement efforts.

Does PD-VD provide support beyond classroom training?

Yes. The service includes gap analysis and vertical audits that identify weaknesses in quality systems and guide corrective actions or CAPA planning.

What is gap analysis in the context of training support?

It involves reviewing documents and records across departments to find deficiencies in the quality system. Experts then recommend steps to strengthen compliance before audits or system upgrades.

How do vertical audits fit into the learning process?

Vertical audits focus on specific failures or deviations, such as out of specification results or major process changes. They help teams understand root issues and improve practices through real world evaluation.

Does completing training help with certification goals?

The company indicates that it supports organizations working toward required certifications, connecting training with broader compliance and operational objectives.

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