Online Training Center (OTC)

 

 

Course Categories :

1. Analytical Laboratory(AL)

2. Computer and software Validation (CSV)

3.Equipment Qualification (EQ)

4. cGood Manufacturing Practice (GMP)

5. Pharmaceutical Technology (PT)

6. Quality Systems (QS)

7. Statistics (ST)

8. Technology Transfer (TT)

9. Process Validation (PV)

10.Microbiology (MB)

 

1. Analytical Laboratory (AL)

Courses offered:

1. Modern HPLC

04LC01 Module 1. Fundamentals

04LC02Module 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 Maintenanace

04LC035 Module 3.5 Troubleshooting of column problems

04LC04 Module 4. Controlling Resolution

04LC05 Module 5.Gradient Elution

04LC06Module 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

04LC11Module 11. HPLC Mehtod 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

04GC01Module 1. Fundamentals

04GC02 Module 2. Instrumentation

04GC03 Module 3. GC Columns

04GC031 Module 3.1 Packed Columns

04GC032 Module 3.2 Capillary Columns: minibore ,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 System

04CSV01Module1. 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

04CSV09Module 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

Custem Developed Systems ,Configurable Systems ,widely used application

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 Framwork

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 of Networks

 

3. Equipment Qualification ( EQ)

Each of the following courses contain 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)

04GMP01 1. GMP for nonsterile manufacturing

04GMP02 2.GMP for nonsterile manufacturing- French

04GMP03 4. 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 personel

04GMP10 10.GMP for Packaging personel-French

04GMP11 11. Risk-based and science approach to GMP

04GMP12 12. Risk Based GMP observations

5. Pharmaceutical Technology (PT)

 

04PT01 1.CRITICAL PARAMETERS IN TABLET MANUFACTURING A MODERN APPROACH

04PT02 2. Equipmrnt selection and process validation

04PT03 3. Crtical Parameters in creams and oinments manufacturing

04PT04 4. Critical parameter in Suspension manufacturing.

04PT05 5. Role of Blend uniformity analysis in Process Validation

07PT06 6. Excipients

07PT07 7. Tablet preformulation studies

6. Quality Assurance (QA)

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)

04ST01 Essential statistical tools for process validation

04ST02 How to design experiments effectively for process validation

04ST03 Process Capability

04ST04 The Statistical Approach to Analytical Methods Validation

04ST05 Statistical Process Control and Process Validation

8. Technology Transfer (TT)

04TT01 Efficient Site technology transfer

9. Process Validation (PV)

04PV01 Validation Basics And Regulatory Requirements

04PV02 Cleaning Validation I

04PV03 Cleaning Validation II

04PV04 Process Variable and how to control you 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)

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