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Certified Pharmaceutical GMP Auditor

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

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

Eligibility

Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ 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 bi-annual executive programme run by the Institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course 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.

Certification and Membership Fees

Rs. 25,000/- for Indian nationals and 800 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500/-( USD 125 for overseas) is to be paid in order to avail the services of Certified Study Resources and training for the preparation of the certification exam.

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 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.

Re- Examination

In case the participant is not able to pass the certification exam in first attempt/exam notification, he/she will have to re- register for the next scheduled examination by submitting re- registration form along with the re- registration fee of Rs. 1500/-(50 USD). However, the participants will be given sufficient flexibility in scheduling their “First” certification exam.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in 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 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, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, 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 and Food industries on regular basis.


Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpiindia.org/ 011 45768446, +91 8130924488, 8587838177, 8130749005, 8448963304

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