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The "most relevant" and critical (must know) aspects of industrial practices will be selected and deliberated along with pratical examples in class room sessions so that participants get better exposure to industry environment. There are seven programs in total.

  • Program 1 - Existing Curriculum
  • Program 2 - For Fresh B. Pharm & M. Pharm Graduates
  • Program 3 - For Industry employees
  • Program 4 - For Science or Pharmacy Graduates or for existing industry employees in Quality Control Laboratory
  • Program 5 - For MBA Final Year Students
  • Program 6 - For Pharm. D Students for Hospital Pharmacy
  • Program 7 - For D. Pharm and B. Pharm Students for Retail Pharmacy
Details of all 7 programs are given below.
Program 1 - Existing curriculum (Fees for Fresh Graduates Rs. 12000 and Industry Sponsored Candidates Rs 15000)
This program will be conducted in modules and each module will last for a week. Overall, the course include following seven modules;

  • Module 1: Overview of Pharmaceutical Industry, Pharmaceutical Legislation, Soft skills and Good Industrial Practices
  • Module 2 : Facilities & Equipment system overview
  • Module 3:
      • Part I: Quality Management Overview and cGMP
      • Part II: Elements of Quality Management System
  • Module 4: Materials Control, Manufacturing *Packaging of Dosage forms and Manufacturing of API.
  • Module 5: Quality Control
  • Module 6: Research and Development
  • Module 7: Regulatory Affairs (RA) and Intellectual Property Rights(IPR)

Each module will begin with precise learning objectives and mentored by a "Module Coordinator (MC)" along with series of expert class-room sessions by "Subject Experts (SE)" for 3 days of the week (Mon, Tue, and Wed). Practical orientation and hands-on exposure training will be conducted at the plant/site of training for another 3 days of week (Thu, Fir. and Sat) whereby the detailed workshop/working examples will be demonstrated based on the class-room sessions.

Further, a wrap-up session will be conducted on each module on Saturday of each week at plant/site to verify the fulfillment of learning objectives of the module. Based on the necessity for particular module, pre-visit to plant/site will be arranged before initiating class-room sessions so that the participants will be able to appreciate theoretical concepts corroborating to the practice/in-use.

Sixth week of training will be preserved as focused training at the industry. The detailed contents for each module are given are below.

Module-1 : Overview of Pharmaceutical Industry and Pharmaceutical legislations
Learning Objectives of Module :

  • Overview of pharmaceutical industry and its role in healthcasre system
  • Career options in pharmaceutical industry
  • Different functional departments and their role in pharmaceutical industry
  • Good Industrial Practices Discipline, personal behavior, and personal safety Human skills Goal setting. Motivation, Time management, communications & Team work.

Module-2 : Facilities & Equipment System overview
Learning Objectives of Module:

  • Facilities Design/Layout
  • HVAC Design
  • Monitoring of clean room & filter validation
  • Water
  • Qualification of equipment
  • Preventive maintenance of equipment
  • Calibration
  • Team work

Module-3 : Part I: Quality Management System overview (QMS) & GMP
Learning Objectives of Module:
Management responsibility: Quality overview.
Documentation practices, Quality evaluation & batch release.

  • Schedule-M, WHO GMP, EU guidelines and USFDA giidelines.
  • Quality assurance - Role and responsibilities
  • Batch reconciliation and Finished goods release
  • Sanitization and hygiene
  • Complaints and recall
  • Contract production and analysis
  • Self inspection and quality audits Personnel Training
  • Personal hygiene, Premises, equipment and materials

Part II : Elements of Quality Management System
Learning Objectives of Module :

  • Change Control
  • Deviation-(planned and unplanned)
  • Incident
  • CAPA
  • Handling of non-conformance
  • Out of specification (OOS)
  • Market recalls
  • Market complaints
  • Material systems
  • Production system
  • Laboratory control systems
  • Facilities and equipment systems
  • Packaging and labeling system - Design of artworks and legal requirements

Module-4 : Materials Control, Manufacturing & Packaging of Dosage forms And Manufacturing of API
Learning Objectives of Module:
Materials Control

  • Vendor Selection
  • Receipt, Sampling and Dispensing
  • Finished Product Warehouse
  • Manufacturing & Packing of Dosage Forms
  • cGMP of Pharmaceutical manufacturing
  • Evolution and Principles of cGMP, Schedule-M, WHO-GMP requirements, EU and USFDA guidelines
  • Manufacturing of Dosage Forms
  • cGMP complied manufacturing and documentation aspects including Environmental monitoring Cleaning (Equipment, Area, Environment), BMR, Process flow, in-process checks and FP analysis
  • Tablets
  • Capsules
  • Liquid Orals
  • Parenterals/ Injectables/ Semisolids/ Ointments
  • Packaging of Dosage Forms
  • cGMP complied packaging and documentation aspects including BPR Process flow, in-process checks, and FP analysis. Labeling requirements for Tablets, Capsules, Liquid Orals, Parenterals / Injectables, and Semisolids / Ointments
  • Manufacturing of API
  • Drug substance development, scale-up, cGMP complied manufacturing and documentation aspects of API production,
  • Unit operations,
  • Handling of solvent
  • Waste management
  • Safety of personnel

Module-5 : Quality Control
Learning Objectives of Module:

  • Chemical and physical analysis
  • Instrumental analysis(GC, HPLC, UV, HPTLC, Dissolution)
  • Standards (RS and WRS) Good laboratory practices
  • Application of microbiology in pharmaceutical testing
  • Impurities (known and unknown) : ICH guideline
  • Calibration of instruments
  • Packing material analysis
  • Deviations Planned and Unplanned
  • Post release monitoring-complaints, recalls

Module-6 : Research and Development
Learning Objectives of Module:
Drug discovery and development process

  • Drug discovery and development algorithm
  • Clinical research process
  • New drug delivery system
  • Understanding on IND, NDA, ANDA/Dossiers

Generic Product Development and registration

  • Requirements for registration and approval
  • Pre-formulation and formulation development activities
  • Analytical method development
  • Process/method/cleaning validation
  • Technology transfer methods
  • BE studies for IR and MR products

Design and Development of per oral novel drug delivery systems

  • Scientific principles involved in the design of novel drug delivery systems(NDDS)
  • Concepts of life-cycle management with NDDS

Module-7 : Regulatory Affairs and Intellectual Property Rights (IPR)
Learning Objectives of Module:
Global view on registration of generic products

  • Requirements for registration and approval of generic products for USFDA (ANDA), EU/AU/SA (Dossier), and TPD (ANDS), etc
  • ICH guidelines
  • Registration of pharmaceuticals
  • Domestic
  • Regulated markets ANDAs, DMFs, eCTDs
  • BA/BE studies and CRO
  • Dossier preparation, submission, approval & maintenance

Important regulatory guidance in generic pharmaceutical registration

  • Guidance dealing with impurity limits, residual solvents limits, bio-equivalence testing for IR and MR products, blend uniformity, stability requirements, dissolution testing, analytical method validation, etc

Patent laws involved with generic products registration

  • TRIPS, GATT, and IPR

Post approval notifications

  • Scale-up post approval changes (SUPAC) and variations

At the end of the first 5 weeks, the trainees will be divided in to groups depending upon the performance during the training for giving focused training at the site for five days.

Program 2 - Short Term Curriculum for fresh B. Pharm & M. Pharm Students for 5 Days (1 Week) Training Program - Fees Rs. 6000 per candidate.

  • Module 1 : Overview of Pharmaceutical Industry, Openings for a Pharmacist
  • Module 2 : Production of API & Formulations
  • Module 3 : Quality Control, Quality Assurance
  • Module 4 : Research and Development / Regulatory Affairs (RA) and Intellectual Property Rights (IPR)
  • Module 5 : HR, Soft skills and Good Industrial Practices
  • Module 6 : End to End Supply Chain
  • Module 7 : Engineering & Projects
  • Module 8 : Accounts, HSE & IT support
  • Module 9 : Marketing & sales
  • Module 10 : Factory Visit

Program 3 - Short Term Curriculum for Industry employees for 2 days training program- (Fees Rs. 3000 per candidate).

  • Module 1 : Overview of Pharmaceutical Industry and Quality Management
  • Module 2 : Candidates can select one of the following -
    • Production of API and Formulations.
    • Regulatory Affairs
    • End to end Supply Chain (Warehousing, Production Planning & Inventory Management And Distribution Management)
    • Sales & Marketing
    • Human Resources
    • Finance.

Program 4 - Curriculum for Science or Pharmacy Graduates or for existing industry employees in Quality Control Laboratory for 4 Weeks Training Program (Fees Rs. 12000)

  • Module 1 : Overview of Pharmaceutical Industry
  • Module 2 : Quality Control-Chemical and physical analysis, Instrumental analysis(GC, HPLC, UV, HPTLC, Dissolution), Standards (RS and WRS). Good laboratory practices, Application of microbiology in pharmaceutical testing, Impurities (known and unknown) : ICH guideline, Calibration of instruments, Packing material analysis, Deviations Planned and Unplanned, Post release monitoring-complaints, recalls
  • Module 3 : 2 weeks practical Experience in an approved Drug Testing Laboratory.

Program 5 - Curriculum for MBA Students for 2 days Training program - Fees Rs. 3000

  • Module 1 : Overview of Pharmaceutical Industry
  • Module 2 : Sales& Marketing or Human Resource Management or Finance in Pharmaceutical Company

Program 6 - Curriculum for Pharm D Students for 4 days Training program - Fees Rs. 5000

  • Module 1 : Overview of Pharmaceutical Industry
  • Module 2 : Hospital Pharmacy Theory
  • Module 3 : Practical Experience in a Hospital Pharmacy

Program 7 - Curriculum for D.Pharm and B. Pharm Students for 4 days Training program - Fees Rs. 3000 ( 50% Scholarship available to selected students)

  • Module 1 : Overview of Pharmaceutical Industry
  • Module 2 : Community Pharmacy Theory including Pharmaceutical Legislations
  • Module 3 : Practical Experience at a wholesaler warehouse and in a Retail Pharmacy


Evaluation :
Trainee's performance will be evaluated by:

  • Assignment
  • Viva-voce with the faculty and the Dean.
  • Written examination at the end of the course if needed.
NOTE: Course content & duration of theory & Practical under go constant improvement & period of training varies from time to time.
Please contact Dean for any details & time table
  • "Golden opportunity for B-Pharm & M.Sc graduates including M.Sc Biotechnology in Quality Control. Applications are invited to work in pharma industries or Allied Industries. Those who are interested should apply immediately"
  • PTI announces new training programme for M.Sc (Chemistry / Microbiology / Biotechnology).
  • Pharma Industry Orientation course in QA & Quality Control.
  • Training Includes Quality Assurence module 3 & Quality control Module 5.
  • Hands on training in instrumentation such as HPLC. Uv- Spectrophotometer,
  • Dissolution test, DT, Hardness, Friability, Packing materiel testing.
  • For Microbiology post graduates :
    specialized training in MLT, Assay of vitamins & antibiotic assay including sterility testing. "Enquire in person".
Download Application Form
Download Broucher
Program Details
Who Should Attend
The Programme is designed for fresh pharmacy graduates / post graduates.
And it will act as a refresher course to those who are working in pharmaceutical industry.

(under the aegis of Karnataka Pharmaceutical Trust)
#3, Ravi Kiran Apartment, 12, Plain Street, Off Infantry Road Cross,
Bangalore - 560 001
Phone : +91 - 80 - 42031273
Dean : 9845175010
E-Mail : ktktraining@yahoo.com
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