Institute of Good Manufacturing Practices India

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Executive Diploma in Pharmaceutial Quality Assurance and Quality Control


When you know the need, you can anticipate problem area or prospective problem areas better than newbie or an untrained person on the field. The existing employees of the industry understand the needs, work scenarios, role and responsibility of the quality division.

The Executive Diploma course targets to benefit such prospective candidates especially those targeting to harness benefits of being part of the much regarded and most important part of the healthcare industry- the quality assurance and quality control division. With the knowledge of healthcare industry and its norms and working models it becomes easier for a candidate to grasp and adjust to delicacy and heavy responsibility of the role of quality inspector. Thus, the executive diploma programme has been launched keeping eye on the goal of preparing and making ready experienced professionals from the industry which after attending the course will have better and clearer view of the quality testing methods, tools and fixing techniques. This specially benefits the employed participants of the course.

Course Modules :

Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical industry ((International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc)

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

Module 8: 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 – Complying with Govt. regulations

Module 11: Computer System Validation (CSV)

Module 12: Laboratory demonstration of QAQC practicals and Instrument Handling

Module 13: Case Studies

Experimental Training

- 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 Sterile preparations.
- 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 and CAPA.
- 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.

Eligibility

All those working in the Pharmaceutical Industry or any sector of Healthcare industry or any other industry type (India or abroad) can apply for this short term programme. Life Science graduate/ B.Pharm/M pharm/MSc/ students pursuing or passed outs of Clinical Research degree or diploma courses are also eligible for the course. Working professionals of any of the following industry types Food manufacturing, Food Ingredient and Additive processing, Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.

Programme Duration

The programme duraion is 6 months.

Programme Deliverables

  • A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry's expectations.
  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Interactive or recorded lectures on all key areas of the programme giving all flexibility to the participants.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.
  • Registration

    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.

    Internship

    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.

    Programmes Fees

    A one-time annual programme fees (lump sum paid at beginning of the course) of Rs. 1,10,000/- (3000 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 450/-(20 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

    IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

    All the participants are obliged to appear for annual exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Pharmaceutical 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. Reddy’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, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, PepsiCo India, Mankind, Beryl Drugs, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.

    Future career prospects of Pharmaceutical QA & QC training

    The above mentioned course is a professional course in true sense promising employment opportunities as well as good growth prospects for already employed attendees of the course. The course addresses personnel needs of the most dynamic healthcare industry which has never ending growth. For each company (small or big or medium sized), quality control division is a must and thus the need for QA personnel is never ending. Not only this the Govt. regulatory and quality check departments also need learned and trained QA & QC staff as part of their auditing and QC compliance testing teams. All this adds to the huge pool of job opportunities.

    With interest in a sector and strong will to take on the responsibility of the delicate role of QA personnel, a positive career graph is a surety.The course adds on additional wings by making you a professional in the field and gives you stronger presence than any other non-QA-QC certified or trained employee.


    How to apply

    For further enquiries, write to or call us on::
    info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175

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    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like