GMP is a critical concept in pharmaceutical industry. According to World Health Organization (WHO), Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled, according to quality standards. Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical GMP regulations and other quality standards. This Programme offers knowledge of basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.

Certified Study Resources

Module 1: Introduction to Good Manufacturing Practices
Module 2: The Requirements of GMP, ISO 9000 and their inter-relationship
Module 3: Audit and Audit Preparation
Module 4: Auditing Systems: Training, Internal Audit, Management review, Deviation, Complaints, CAPA
Module 5: ICH Q8, Q9, Q10 and their role in Pharmaceutical Industry
Module 6: ISO 19011 and 21 CFR Part 11 Guidelines for Auditing
Module 7: Auditing the Warehouse, Production, Packaging and Laboratories, Sterile Manufacturing Facility
Module 8: Good Manufacturing Practices and its Regulations (International perspective)
Module 9: Computer System Validation

Eligibility

Any Graduate/ 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 Executive Diploma, Industry Certificate, and Certificate Programmes.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective Online 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.

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be awarded the professional certification of Certified Pharmaceutical GMP Auditor by Institute of Good Manufacturing Practices India (IGMPI). All the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing placement assistance to 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 food and agriculture 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 like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future Prospects of Certified Pharmaceutical GMP Auditor

Good Manufacturing Practice describes the key requirements for all aspects of commercial production, storage, and distribution necessary to ensure a consistent product that conforms to all safety, quality, and consumer attribute requirements. It involves application of defined principles and practices in company organization and management, including staff training, provision of process and storage facilities (buildings and equipment), quality assurance, new product development, legislation, and product distribution.

Auditor review for the completion, updating, correctness and overwriting in the pharmaceutical industries, it provides management with information about how effectively the company controls the quality of their processes and products. Certified Pharmaceutical GMP Auditor programme expertise the participants to work at various positions such as Quality Auditor, Data Integrity Specialist, Technical Auditor, Data Auditor in the reputed companies.

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Programme Fee Details

ONLINE PROCTORED EXAMINATION PATTERN

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

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