Post graduate Diploma/Professional Diploma Online in Quality Assurance and Quality Control New Delhi NCR, India

Post graduate Diploma/Professional Diploma in Pharmaceutical Quality Assurance and Quality Control (PGDQAQC/PDQAQC)

IGMPI

The programme targets graduate, post graduate and already employed candidates with keen interest in the Quality Assurance and Quality Control divisions of an industry. The Post graduate Diploma/Professional Diploma programmes 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, online sessions and lectures, online 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.

Programme Modules

Module 1: Quality Assurance and Quality Control in pharmaceutical industry

Basics of Quality

GMP Regulations: USFDA, EU, TGA, ICH, WHO

Need of Quality

Introduction to QA and QC

Module 2: Qualification and Validation

Introduction to Validation

Validation Master Plan

Qualification: DQ, IQ, OQ, PQ, Calibration and Maintenance

Validation: Process Validation, Analytical Method Validation, Water System Validation, HVAC, Cleaning Validation, Sterilisation Validation, Computer System Validation

Module 3: Quality Assurance and Quality Control- Possible Problems and Fixes

Deviations

Out of Specification (OOS) and Out of Control (OOT)

Change Control

Compliance

CAPA

Module 4: Quality Statistical Tools and Techniques

Quality Testing Tools

Quality Assurance Tools

Statistical Process Control

Quality Management Tools

Module 5: Quality Testing and its types

Analytical Techniques

API testing

Raw material testing; Excipients, intermediates and container closure

Finished Product Testing

Stability Testing

Microbiological testing

Module 6: Drug Stability Study

ICH Stability Testing

Stability Testing of new Drug Substances and Products

ICH Impurities Testing

Module 7: Regulatory Authorities and Quality Certification

Global Regulatory Authorities; USFDA, EMA, UKMHRA, TGA, CDSCO

ICH, WHO, PIC/S

Module 8: ICH Guidelines and ISO

International Council on Harmonisation (ICH)

ICH Guidance on: Quality, Safety, Efficacy and Multidisciplinary

International Organization for Standardization (ISO)

ISO 9000, 9001:2015 series

Module 9: Quality Risk Management

ICH Quality Risk Management

Guidelines on Quality Risk Management: USFDA, WHO, EU

Module 10: Total Quality Management

ICH Pharmaceutical Quality System

Quality Culture

Quality Policy

Quality Commitment

Continuous Improvement: Kaizen, LEAN Six Sigma

Module 11: Addressing Internal and External Quality Issues

Quality Defects

Defect Identification Tools

Root Cause Investigation

Deviation, Change Control, CAPA. Complaint and Recall Handling

Module 12: Inspections and Audits Types, Non Compliance handling

Types of Audits and Inspections

Regulatory Audits (FDA, MHRA, PMDA, TGA, DCGI)

Audit Observations, Response letters, Warning letters, Revocation of GMP license

Breach Reports

Module 13: Good Documentation Practices, SOPs, Protocols, etc

Good Documentation Practices (GDP)

Data Integrity

SOP, Analytical Test Protocol, Work Instruction, Checklists, Log books

Module 14: Online Laboratory demonstration of analytical techniques

Qualitative and Quantitative techniques

Analytical and Bioanalytical methods

Titrimetric, Electrochemical, Spectroscopic and Chromatographic techniques

Module 15: Software Based Analysis

Empower

Topspin

Lab solution

LIMS

Module 16: Industry Based Case Studies

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Professional Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Professional Diploma).

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

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 online live sessions on all key areas of the programme giving all flexibility to the participants.
– Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
– All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
– 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.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Professional 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 expected to appear for an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma/Professional Diploma in Pharmaceutical Quality Assurance and Quality Control by Faculty of Good Manufacturing Practice, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. 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 its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Johnson & Johnson, Roche, Novartis, Merck & Co., AbbVie, GlaxoSmithKline, Pfizer, Sanofi, Bayer, Eli Lilly & Co., Novo Nordisk, Teva Pharmaceutical Industries, Dr. Reddy’s Laboratories, Lupin Limited, Torrent Pharmaceutical Ltd., Cipla Limited, Emcure Pharmaceuticals, Sun Pharmaceutical Limited, Mankind Pharma, Ajanta Pharma, IPCA Laboratories etc. The IGMPI’s Corporate ResourceDivision actively recommends our students and training participants for various jobrequirements and specialized roles to Human Resource, Talent Acquisition as well as the headsof various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects of Pharmaceutical QA & QC Training

QA & QC are quite 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 programme a thorough and complete knowledge of the work area. Our online programme works to prepare candidates for the same. The interactive online programmes thus 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.

View Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free) , Phone: +91 11 26512850