Online Training Center
1. Analytical Laboratory (AL)
Courses offered:
1. Modern HPLC
04LC01 Module 1. Fundamentals
04LC02 Module 2. Instrumentation
04LC03 Module 3. HPLC Columns
04LC031 Module 3.1 Column design and spcifications
04LC032 Module 3.2 Column Characteristics and Types of Packing
04LC033 Module 3.3 Column Selectivity in reversed-phase Columns
04LC034 Module 3.4 Column Maintenance
04LC035 Module 3.5 Troubleshooting of column problems
04LC04 Module 4. Controlling Resolution
04LC05 Module 5. Gradient Elution
04LC06 Module 6. Reverse Phase and Ion Pair
04LC07 Module 7. Troubleshooting
04LC071 Module 7.1 Troubleshooting I
04LC072 Module 7.2 Troubleshooting II
04LC08 Module 8. Qualification of HPLC system
04LC09 Module 9. Validation of LIMS
04LC10 Module 10. Method Validation
04LC0101 Module 10.1 Analytical Approach
04LC0102 Module 10.2 Statistical approach
04LC11 Module 11. HPLC Method Development
04LC0111 Module 11.1 Theoretical Considerations
04LC0112 Module 11.2 Method Development Strategy
04LC0113 Module 11.3 Computer-Assisted Methods Development
04LC0114 Module 11.4 Enhancing Sensitivity
04LC0115 Module 11.5 Temperature Effects
04LC0116 Module 11.6 Solvent Optimization
04LC12 Module 12. Bioanalytical Method Development
04LC13 Module 13. Bioanalytical Method Validation
2. Modern Gas Chromatography
04GC01 Module 1. Fundamentals
04GC02 Module 2. Instrumentation
04GC03 Module 3. GC Columns
04GC031 Module 3.1 Packed Columns
04GC032 Module 3.2 Capillary Columns: minibar, microbore, Megabore
04GC033 Module 3.3 Column Selection
04GC04 Module 4. Fundamentals of Separation Design
04GC041 Module 4.1 Sample Considerations
04GC042 Module 4.2 Media and Column Selection
04GC043 Module 4.3 Developing a GC separation
04GC044 Module 4.4 Controlling Resolution - Temperature Programming
04GC05 Module 5. GC System Trouble-Shooting
04GC06 Module 6. Qualification of GC System
04GC07 Module 7. GC method Validation
2. Computer and Software Validation (CSV)
Courses offered:
1. Validation of Computer and Software Systems
04CSV01 Module1. Fundamentals
04CSV02 Module 2. 21 CFR Part 11
04CSV03 Module 3. Standards
04CSV04 Module 4. System Development Lifecycle
04CSV05 Module 5. Validation Master Plan
04CSV06 Module 6. Strategies for off-the-shelf software
04CSV07 Module 7. Strategies for MRP and ERP systems
04CSV08 Module 8. Strategies for LIMS I
04CSV09 Module 9. Qualification IQ, OQ, PQ
04CSV10 Module 10. Validation Tools
04CSV11 Module 11. Computer System Validation SOPs
04CSV12 Module 12. Vendor Audit
04CSV13 Module 13. Computerized System Validation Strategies
Custom Developed Systems, Configurable Systems, widely used applications
and shopfloor equipment.
2. Advanced Computer and Software System Validation
04ACSV01 Module 1. How to develop an effective Validation Master Plan
04ACSV02 Module 2. Good Automated Manufacturing Practice (GAMP)
04ACSV03 Module 3. Validation strategies for ERP system
04ACSV04 Module 4. Validation Strategies for LIMS II
04ACSV05 Module 5. Validation of Legacy Systems
04ACSV06 Module 6. A Risk-based Approach to Part 11
04ACSV07 Module 7. Part 11 Gap Analysis and Remediation
3. Corporate Computer Systems Network Validation
04NV01 Module 1. Validation Framework
04NV02 Module 2. Regulatory Requirments for Networks
04NV03 Module 3. Network Definitions
04NV04 Module 4. Network Components
04NV05 Module 5. Validation Strategy for Networks
04NV06 Module 6. Specifications and Security of Networks
3. Equipment Qualification (EQ)
Courses offered:
Each of the following courses contains 3 modules IQ, OQ, and PQ
04EQV01-03 1. Qualification of V-blender
04EQTP01-03 2. Qualification of Tablet press
04EQTC01-03 3. Qualification of Tablet Coating Pan
04EQCF01-03 4. Qualification of Capsule Filler
04EQTI01-03 5. Qualification of Tablet and Capsule Inserter
04EQIN01-03 6. Qualification of an Incubator
04EQAH01-03 7. Qualification of air handling system and water system
4. cGood Manufacturing Practice (GMP)
Courses offered:
04GMP01 1. GMP for nonsterile manufacturing
04GMP02 2.GMP for nonsterile manufacturing- French
04GMP03 3. GMP as per Health Canada
04GMP04 4. GMP as per Health Canada - French
04GMP05 5. GMP for sterile manufacturing
04GMP06 6. GMP for sterile manufacturing- French
04GMP07 7. Documentation Required by TPD for Sterile validation.
04GMP8 8. GMP for API as per ICH Q7A
04GMP9 9. GMP for Packaging personnel
04GMP10 10.GMP for Packaging personnel-French
04GMP11 11. Risk-based and science approach to GMP
04GMP12 12. Risk-Based GMP Observations
5. Pharmaceutical Technology (PT)
Courses offered:
04PT01 1. CRITICAL PARAMETERS IN TABLET MANUFACTURING A MODERN APPROACH
04PT02 2. Equipment selection and process validation
04PT03 3. Critical Parameters in Creams and Ointments Manufacturing
04PT04 4. A critical parameter in Suspension manufacturing.
04PT05 5. Role of Blend uniformity analysis in Process Validation
07PT06 6. Excipients
07PT07 7. Tablet pre-formulation studies
6. Quality Assurance (QA)
Courses offered:
04QA01 ISO 9000 Quality Systems
04QA02 Effective auditing techniques for TPD and FDA compliance
04QA03 The modern quality system that can fit FDA and EMA model Requirement
04QA04 The modern quality approach
04QA05 AUDITING? IS IT AN EFFECTIVE TOOL, AN ART OR WHAT?
04QA06 Out-of-Specification Results! How to deal with it efficiently?
7. Statistics (ST)
8. Technology Transfer (TT)
Courses offered:
04TT01 Efficient Site technology transfer
9. Process Validation (PV)
Courses offered:
04PV01 Validation Basics And Regulatory Requirements
04PV02 Cleaning Validation I
04PV03 Cleaning Validation II
04PV04 Process Variable and how to control your process?
04PV05 Process Validation Failures
04PV06 HOW ABOUT GRANDFATHER PRODUCT VALIDATION?
04PV07 Current Regulatory Requirements for Process Validation
04PV08 Role of Blend Uniformity Analysis in Process Validation
04PV09 Scale–up Product and Process Optimization
04PV10 Process Capability and Validation
04PV11 Equipment selection for process validation
04PV12 How to organize an efficient validation file
10. Microbiology (MB)
Courses offered:
04MIC01 INITIATING THE VALIDATION OF THE MICROBIOLOGICAL METHOD
04MIC02 REVIEW OF PROPOSED AND CURRENT CHANGES TO METHODS AND NEW TECHNOLOGY
04MIC03 ENSURING COMPLIANCE cGMP with FDA, TPD
04MIC04 MICROBIOLOGY EQUIPMENT QUALIFICATION
04MIC05 VALIDATION OF COMPENDIAL METHODS
04MIC06 QUALIFICATION OF CLEANING AND DISINFECTION PROGRAM
04MIC07 DEVELOPING AND QUALIFYING “BEST OF” ENVIRONMENTAL PROGRAM FOR NON-STERILE AND STERILE ENVIRONMENTS
04MIC08 DEVELOPING ACTION AND ALERT LEVELS FOR MICROBIAL METHODS
04MIC09 HANDLING MICROBIAL OOT AND OOS RESULTS