• Evaluation
• Basic chromatography
• Principle of TLC,FTIR,GC,HPLC and MASS
• CD Presentation (Audio / Video)
• Trouble shooting of the Equipment
• Theory on GC and HPLC
• System Suitability Test
• OVI by GC Headspace technique
• SOP's / GMP / GLP
• Basic about Calibration & Validation
• Practical on GC and HPLC
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Regulated Bio-Analysis with LC-MS

Duration: 30 days Part time course

Eligibility: Fresher's / Experience with B.Sc./M.Sc/B.Pharm./M.Pharm/Ph.D/B.E.Chemical Course material is provided from the institute. Theory and Hands on training on LC-MS, course material kit will be provided by us and for practicals will be at our site.

Bio- Analysis in drug Discovery:

• Pre clinical development study
• Clinical development study
• Overall drug development and it’s parameters

Study:

• Sample preparation and it’s technique
• Fundamentals of HPLC / UPLC and Mass spectrophotometer
• Principal of MASS
• Application of MASS

Application of Bio- Analytical Method

• Follow the FDA Guideline and its norms
• Validation of the Method which includes

1. Specificity
2. Selectivity
3. Accuracy
4. Precision
5. Recovery
6. Ruggedness
7. Robustness
8. Stability

Basic Pharmaceutical Course

Duration: 15 Days x 2 Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd Course material is provided from the institute.

• Classifications for Tablet/ capsules/ Liquid/ Ointment/ Parenterals/ Ophthalmic & Aerosols.
• Quality control Tests
• Disintegration Tests (Practical)
• Dissolution Test
• Weight variation for Tablet and capsule
• Reporting of Finished product
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Advance Quality Assurance

Duration: 20 Days x 2.5 Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd/B.E.Chemical Course material is provided from the institute.

• Evaluation
• Process flow chart for Tablet/Capsule/RM
• Organization chart
• BMR
• IPQC & IPQA
• Documents & data control
• SOP on SOP
• Out Of Specification (OOS)
• Out Of Calibration (OOC)
• Change control
• Deviation
• CAPA
• Stability study
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Pharmaceutical Calculations

Duration: 12 Days x 2.5Hrs.

Eligibility:Freher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd Course material is provided from the institute.

• Units of measurement
• Expression of concentrations
• Density, Volume & Mass
• Volumetric analysis
• pH measurement
• Interpretation and presentation of results
• Method selection & validation
• Range
• Quality assessment
• Identifying source of error
• Spectroscopy
• Exercises
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Process Research & Development

Duration: 25 Days x 2.5Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd/B.E.Chemical Course material is provided from the institute.

• Basic Introduction
• Literature search
• Technical evolution of molecule
• Process development
• Case study and practice
• Importance of IPR
• Selection of route of synthesis
• Tentative Raw Material Consumption (RMC) Norms
• MSDS for RM & FP
• Process optimization
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Method Development by HPLC

Duration: 12 Days x 2.5Hrs.

Eligibility: Should have basic knowledge of HPLC and its operation B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd/B.E.Chemical Course material is provided from the institute.

• Separation techniques
• Selection of HPLC methods
• Initial condition
• Selectivity optimization
• System optimization
• Method validation
• SST
• Practical
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Analytical Method Validation

Duration: 20 Days x 2.5Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd/B.E.Chemical Course material is provided from the institute.

• HPLC theory
• SST (System Suitability Tests)
• Validation parameters

• Analysis of all validation parameters on single/combined drug
• Specificity
• Accuracy
• Precision
• Linearity
• Robustness/ Ruggedness
• Filter study
• Stability
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Calibration of Pharma Equipments

Duration: 15 Days x 2.5Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd Course material is provided from the institute.

Calibration of

• pH meter
• Analytical balance
• Autotitrator
• GC
• HPLC
• FTIR
• TOC
• KF
• Viscometer
• UV visible spectrophotometer
• Dissolution
• Polarimeter
• Particle sizing system
• Ion chromatography
• Atomic Absorbance Spectrophotometer
• Autotitrator
• GC with headspace and auto sampler
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Cleaning Validation

Duration: 15 Days x 2.0 Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd Course material is provided from the institute.

• Validation (Basic and Definition)
• Types of Validation
• Cleaning Validation
• Objective / Introduction / Background
• Philosophy
• Regulatory Requirement
• Limit / Acceptance Criteria
• Cleaning Procedure
• Sampling Techniques / Sampling Plan
• Analytical Methods
• Documentation (Cleaning Manual, CV Protocol, CV report etc.)
• Cleaning agents
• MACO calculation
• Types of Cleaning
• Equipment metrix for cleaning

Regulatory Affairs

Duration: 25 Days x 2.5Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd Course material is provided from the institute.

• Introduction to RA
• Regulatory authorities around the world
• ICH guidelines
• GMP/ GLP/ Schedule M
• WHO
• DMF (Drug Master File)
• Patent
• IPR
• Site Master File
• CTD guideline
• Validation master plan
• BMR
• Presentation by the candidate
• Mock Interview
• Exam and certificate issue

Stability Study

Duration: 20 Days x 2.0 Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc./B.Pharm/M.Pharm/P.hd Course material is provided from the institute.

• Introduction to stability
• Regulatory requirements
• Importance
• Long term stability and short term stability
• Photo stability
• Forced degradation study
• Climatic zones around the world
• SOP/protocol/report/planner/testing
• Shelf life assigning
• Types of chamber
• Stability failure
• Different guidelines and references
• Selection of batches
• Examination

Advance Toxicity Training Course

Duration: 15 Days x 2.0 Hrs.

Eligibility: Fresher's / Experience with B.Sc./M.Sc/B.Pharm./M.Pharm/Ph.D/B.E.Chemical Course material is provided from the institute.

• Basic principles of toxicology
• Toxicity guidelines and good laboratory practice (GLP) training
• Environmental, food & chemical toxicity
• Practicals on analytical methods (HPLC & GC) for detection of toxicants
• Clinical toxicit testing (organ funcyion tests)
• Drug toxicity study (preclinical & clinical)
• Toxicants & human health risk assessment
• Identification & quantification of herbal phytochemicals for remediation of toxicity
• Presentation by the candidate
• Mock interview
• Exam & certificate issue