BII Global

In-House Customized Trainings

QbD and Lifecycle Management of Analytical Methods

Process Scale-up & QbD principle in pharmaceutical Product Development

PRAC - EU Pharmacovigilance Risk Assessment

Chemical Process Development & Scale-Up

Bioequivalence, Dissolution & Biowaivers

Clinical Trials – Strategic Planning & Execution

Data Science & AI in Pharma & Healthcare

Capillary electrophoresis–Mass spectrometry

Manufacturing Processes and Troubleshooting

Pharmaceuticals – Sales and Marketing

Effective - Technology Transfer

Biorelevant Dissolution Testing - Methodologies & Application in Drug Development

Generics & Super Generics

DOE – Design of Experiments

Biosafety & Bio risk

Process Validation/Verification

QBD - Quality by Design

EU - Regulations

E&L - Extractable & Leachable

Biosimilars

CMC Analytical

Data Integrity & Computer System Validation

OPV - Ongoing Process Verification

Industry 4.0 - Pharm

Nitrosamines Impurities

Lyophilization Technology

In-Vivo In-Vitro

Aseptic Filling

Genome Sequencing

Root Cause Analysis in Pharma

Advancing Pharmaceutical Quality™ (APQ)

Analytical Development

Logistics, Packaging & Cold Chain

GDP Audits

Cross Contamination Control

Granulation & Tableting

Current Requirement on Aseptic

ICH Q7 Compliance

Risk Based Stability Assessment

Validation in Pharma Analysis

21 CFR Part 820.30

ISO Standards – 11040 Series, 14971, 11608 Series, 13485 ASTM

Sterilization - ISO 11137/11135

Human factor study

Contamination Control

Validation of Analytical Test Procedures & Measurement Uncertainty

Analytical Methods for Cleaning Validation

BF & GF and Injectability

Computerized Systems Validation and Electronic Data Integrity

Shipping Studies for US & EU market requirements

Auto-injector & Pen Device Functionality testing requirement

EU MDR guideline

Computer Systems Compliance eClinical and AI/ML

ICH Q7 Training 2025

Medical accessories (Compliance document/testing)

Pharma – Production challenges

Advanced Clinical Research & Clinical Trials

Drug Formulation & Analytical Techniques

Research & Drug Discovery

Toxicology

Shutdown & Turnaround

Quality Requirement for Biotech

Pre-clinical & Clinical Development

Signal detection & Signal management – QPPV

ICH Q12 – Life cycle management

Deviation Management & CAPA

Clean Rooms & HVAC

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