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ABOUT TRUST ABOUT PROGRAMME CURRICULUM COMMITTEE FACULTY PROGRAM DETAIL APPLICATION FORM CONTACT US
PROGRAM DETAILS

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. The 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
  • GMP ICH Q7A
  • 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.

 

Evaluation :
Trainee's performance will be evaluated by:

  • Assignments
  • Literature survey
  • Hands on training
  • Week end evaluation at the site
  • Seminar presentation and
  • Written examination at the end of the course
 
Weekend programme
Weekend programme (on Saturday & Sunday) starts on 19th April 2014 for four weeks On
Part I: Quality Management overview & CGMP Management System.
Part II: Elements of Quality Management System (Module 3).

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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.

 
 
 
CONTACT US
 
PHARMA TRAINING INSTITUTE
(under the aegis of Karnataka Pharmaceutical Trust)
#3, Ravi Kiran Apartment, 12, Plain Street, Off Infantry Road Cross,
Bangalore - 560 001
Phone : +91 - 80 - 3202 2198
Dean : 94800 88629
E-Mail :info@pharmatraininginstitute.org
 
 
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