The document describes a post graduate diploma program in Pharmaceutical Quality Assurance and Quality Control offered by the Institute of Good Manufacturing Practices India (IGMPI). The 12-month program covers topics like quality assurance, quality control, validation, documentation, and case studies. It aims to provide knowledge on quality issues, industry needs, and techniques. Graduates can work as QA/QC managers or officers in pharmaceutical and healthcare industries. IGMPI also offers other programs in areas like GMP, regulatory affairs, and clinical research.
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Pharma quality assurance and control
1. Post Graduate/ Executive Diploma in
Pharmaceutical Quality Assurance and Quality
Control
Approved and Certified by Quality Council of India, Government of
India
Institute of Good Manufacturing Practices India
B-271, Chattarpur Enclave Phase-2, 100 Feet
Road, Chattarpur, New Delhi-110074 (India)
Telephone: +91 8130924488,+91 11 65353339
Website: www.igmpiindia.org
E-mail: info@igmpiindia.org
2. About IGMPI
Institute of Good Manufacturing Practices India, registered as a non-profit society
with Government of India and a member (as a higher/professional Education
Institute) of Quality Council of India(QCI)-which is an autonomous body and an
accreditation authority for education & vocational training providers under the
Department of Industrial Policy & Promotion, Ministry of Commerce & Industry,
Government of India -presents unique, friendly and interactive platform to get rid
of all your GMP related glitches. Based on high standard of quality, the training
programmes in Pharma and healthcare GMP, Quality Assurance and Quality
Control, Regulatory Affairs, IPR, Pharma Product Management etc. have been
approved and certified by Quality Council of India.
Website: www.igmpiindia.org Email: info@igmpiindia.org
3. IGMPI Work Ideology
IGMPI’s work ideology remains
“When outcome matters wise integration of
knowledge and technology becomes essential to
promote best results.”
Website: www.igmpiindia.org Email: info@igmpiindia.org
4. Quality Assurance: Its importance
creates its need!
Quality assurance is a broader concept
ranging from development, quality
control, production, distribution, and
inspections that individually or
collectively influence the quality of a
product. Quality assurance department
does hold an important responsibility of
making sure effective quality control
tests are included at right stages and
executed perfectly at proper stages of
product life cycle. Quality Assurance
applies for both drug substances (APIs)
and medicinal products, and includes
current Good Manufacturing Practices
(cGMPs), as well as any necessary
analytical testing and stability studies.
Quality
Assurance
Planning
Design
Develop-
ment
SOPs
Validation
Audits
Website: www.igmpiindia.org Email: info@igmpiindia.org
5. Course Modules
Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare
industries
Module 2: Qualification and Validation
Module 9: Documentation, Good Documentation Practices, SOPs, Protocols, etc.
Module 7: Total Quality Management and GMP: Quality Risk Management, Assessing
Quality Concerns at Different Work Units or Areas
Module 5: Quality Testing Tools and Techniques
Module 3: Quality Assurance and Quality Control- Possible Problems and Fixes
Module 10: Addressing Internal and External Quality Issues – Complying with Govt.
regulations
Module 8: Setting up Quality Control Checks: Inspections and Audits
Module 6: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000
Module 4: Types of Quality Testing (models, types, procedures etc.)
Module 11: Case Studies
Website: www.igmpiindia.org Email: info@igmpiindia.org
6. About Programme
Eligibility: Any Graduate/ Post graduate/ PhD (Post Graduate Diploma)
Any working professional with 6 months of experience
(Executive Diploma)
Post Graduate Diploma in Quality Assurance & Quality Control: 12
months (Regular/ Distance)
Executive Diploma in Quality Assurance & Quality Control: 6 months
(Part-time/ Distance)
Fees:
Regular: Rs 1,35,000 /- Programme fee, Rs 3,000/- Examination fee.
Part-Time: Rs 70,000 /- Programme fee, Rs 3,000/- Examination fee.
Distance cum e-learning: Rs 14,000/- Programme fee, Rs 300/- per module
Examination fee.
Website: www.igmpiindia.org Email: info@igmpiindia.org
7. Objective of the Programme
•To make the participants learn the need of QA & QC, current
norms and regulations for compliance and non-compliance .
•To provide knowledge of testing tools and techniques for
overcoming QA problems and fixing the methods.
•To provide appropriate knowledge about varied quality issues,
concerns, industry needs, techniques, legislative norms and
precise knowledge for identifying and overcoming quality related
problems
Website: www.igmpiindia.org Email: info@igmpiindia.org
8. •To provide knowledge of proper documentation, qualification
and validation, and risk based approaches.
•It also provides the knowledge of various analytical
instrumental techniques, method development, protocol and
SOP writing etc.
Website: www.igmpiindia.org Email: info@igmpiindia.org
9. Q A: Not one but all
industry verticals need to
have this division.
Quality assurance and quality control is the area that gets lot of attention in
Pharmaceutical industries. After completing this course, the student can work as:
•QA/QC Manager
•QA/QC Officer
•Scientific Officer in QA
•Senior Quality Analyst
•QA Project Manager
•Senior Executive
•QA Coordinator
The students can ensue their career in Pharma, Healthcare, Ayurvedic,
Homeopathy, Food manufacturing or any related industry.
Website: www.igmpiindia.org Email: info@igmpiindia.org
10. Placement Assistance
Professional resume writing
Providing interview skills
Conducting mock interviews
No extra fee for placement programme
Associated with many Pharma and Healthcare
industries
Website: www.igmpiindia.org Email: info@igmpiindia.org
11. Participation from the Industry
In recent months the Institute has witnessed more and more participation from
professionals working with
Website: www.igmpiindia.org Email: info@igmpiindia.org
12. Website: www.igmpiindia.org E-mail: info@igmpiindia.org
Other Programmes IGMPI Offers
Post Graduate and Executive Diploma in Pharmaceutical:
Good Manufacturing Practices
Regulatory Affairs
Intellectual Property Rights
Clinical Research
Good Laboratory Practices
Product Management
Nanotechnology
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13. For more details/counseling, you can call/write us: at +91 8130924488,
+91 11 65353339 & programmes@igmpiindia.org