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 and 3 A-
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
- Program 8 - Both Industry employees and fresh graduates on Sales & Marketing
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. 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)
Last 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
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 - - Industry employees for 1 Day Workshops (Fees Rs. 2000 per candidate) on any one of the following Topics.
- Quality Management and Good Laboratory Practices ( GLP )
- Regulatory Affairs
- Regulatory Affairs
- Production of API and Formulations and Good Manufacturing Practices ( GMP)
- End to end Supply Chain (Warehousing, Production Planning & Inventory Management And Distribution Management)
- Sales & Marketing
- Human Resources
- Finance.
- Stress Management
Program 3 A - Industry employees 1 Day a week (Every Saturday) program on Quality Management for 3 Months (Fees Rs. 10000 per Candidate.)
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 :
6 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.
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