Post Graduate Diploma in Quality Assurance and Quality Control(One Year Full Time : QCI, Government of India Approved & Certified)
The course targets graduate, post graduate and already experienced candidates with keen interest in the Quality Assurance and Quality Control divisions of an industry. The postgraduate diploma course is aimed to make the participant learn the:
- Need of QA & QC
- Where and when to apply
- Current norms and regulations (for both compliance and non-compliance)
- Testing tools and techniques
- Overcoming QA problems and fixing methods
All the above as well as practical knowledge about the subject has been included as case studies, practice modules, lectures, classrooms and discussions etc. The sole aim remains to make ready candidates with ample and appropriate knowledge about varied quality issues, concerns, industry needs, techniques, legislative norms and precise knowledge for identifying and overcoming quality related problems arising at work place. With this knowledge the participant can confidently aim to apply for and be a part of healthcare production units, quality check divisions of manufacturing plants and even quality auditing boards and regulatory authorities.
Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare industries
Module 2 : Qualification and Validation
Module 3 : Quality Assurance and Quality Control- Possible Problems and Fixes
Module 4: Types of Quality Testing (models, types, procedures etc.)
Module 5: Quality Testing Tools and Techniques
Module 6: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000
Module 7: Total Quality Management and GMP, Quality Risk Management, Assessing Quality Concerns at Different Work Units or Areas
Module8: Setting up Quality Control Checks, Inspections and Audits
Module 9: Documentation, Good Documentation Practices, SOPs, Protocols, etc.
Module 10: Addressing Internal and External Quality Issues â€“ Complying with Govt. regulations
Module 11: Laboratory demonstration of QAQC practicals and Instrument Handling
Module 12: Case Studies
- Analytical methods Validation
- Protocol preparation for various operations and processes
- Records preparation- MFR, BFR, labeling and packaging records
- SOP writing for operating all equipments from regulatory perspective
- Documentation for quality control checks for in process and finished products
- Validation and calibration of analytical instruments used in manufacturing
- Process Validation of various pharmaceutical dosage forms.
- Quality control tests for Solid, Semisolids, liquids, ophthalmic, modified release and
- Stability study protocol for API, Final product
- Stability studies (Accelerated and photostability) as per ICH Guidelines
- Documentation for product recalls, product complaints, returned goods, change control
- Documentation for inspections and audits
The diploma course is aimed to make the participant learn the need of QA & QC, where and when to apply, current norms and regulations (for both compliance and non-compliance), testing tools and techniques & overcoming QA problems, fixing methods, documentation, qualification and validation, GLP, and risk based approaches. All the above as well as practical knowledge about the subject has been included as case studies, practice modules, lectures and discussions etc.
The post graduate diploma in quality assurance and quality control offers the combined knowledge of theoretical and practical knowledge in all areas that affects the drug quality. It also provides the working knowledge of various analytical instrumental techniques, method development, documentation, protocol and SOP writing etc.
Any Indian or overseas applicants must fulfill following criteria for enrolling into the one year QA & QC program. The applicant must be a graduate in any discipline.
The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty.. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.
All the efforts will be made in the form of 3 months internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.
A one-time annual programme fees (lump sum paid at beginning of the course) of Rs. 90,000/- (2,000 USD for overseas students), which can be paid in installments. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, every student has to pay an examination fee of Rs 400/-(15 USD for overseas students) per module as per the examination notification of the Institute. 10% of fee concession is applicable to applicants belonging to SC/ST, Physically Handicapped (PH), Ex-servicemen, Defence personnel & their progeny or those who belong to Economically Weaker Section (EWS)/ Below Poverty Line (BPL).
Examination & Certification
All the participants are obliged to appear for annual exam at the end of the course. After successful completion, the participants will be awarded Post Graduate Diploma in Quality Assurance and Quality Control. For all the above mentioned modules elaborate course material and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
Placement Assistance & Corporate Relations
The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddyâ€™s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc.
Future career prospects of QA & QC Training
QA & QC are quiet essential parts of pharmaceutical, biotech and all other verticals of the healthcare industry. the two find application in other industry types as well but since healthcare is the most dynamic industry and the one concerned with health and well-being of the population, QA&QC are highly treated and most regarded divisions to settle in thus the career prospects and opportunities are never ending.
With this important role in the industry, sense of responsibility is expected from the joining employee and of course a thorough and complete knowledge of the work area. Our course works to prepare candidates for the same. This has been tailor made to suit needs of employed as well as yet to be employed candidates targeting to take over the quality assurance and quality control divisions of the industry.
How to apply
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