Institute of Good Manufacturing Practices India
Global accredited training & certification provider
Approved by Quality Council Of India (QCI), Government of India
Accredited Vocational Institution of Ministry of HRD, Government of India
An ISO 9001:2008 Certified Organisation
Registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD

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Certified GCP PROFESSIONAL

IGMPI is offering an opportunity to get certified and become a certified GCP Professional. This certification is meant for experienced professionals who are already a part of clinical research industry and are aware of the GCP (good clinical practice) regulations applicable in their line of work. To enable the participant, clear the qualifying exam for obtaining the certification, the institute will be offering proper training materials which will be provided without any extra cost save for the cost for applying for the Certification Examination.

This certification is aimed at improving the conceptual knowledge of the participant for Good Clinical Practices and resolving any dilemmas that a working professional may face regarding the application of GCP guidelines at his workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study material has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials.GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Several specialized topics have been added to guide the participant through ICH GCP regulations, compliance needs, comparison of Indian GCP guidelines vs. ICH GCP guidelines etc.

The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GCP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. An advanced training having rigorous case studies based methodology will be imparted to all participants for preparing for the Certifying Examination.

Certified Study Resources

· Overview of the clinical research process · Introduction: ICH Guidelines · The principles of ICH GCP · ICH GCP guidance on Institutional Review Board, Sponsor responsibilities, Investigator responsibilities, Monitor responsibilities, Clinical trial protocol and amendments · ICH GCP guidance on the essential documents for the conduct of a clinical trial · Relationship between Good Laboratory Practices (GLP) and GCP · FDA regulations relating to Good Clinical Practice and Clinical Trials

· WHO GCP · European Union (EU) GCP · UK GCP · GCP in Indian Context · Indian GCP vs. ICH GCP · Good Clinical Practice guidelines for Medical Devices: ICH GCP and ISO 14155 · Outsourcing clinical trials and Vendor GCP audits · Consequences of GCP non compliance and dealing with non compliance. · Case studies

Eligibility

The participants must have three years of on-the-job experience in any of related areas. Any Life Science graduate/ B.Pharm/M pharm/MSc/Phd in science disciplines/ any diploma /degree holders, working professionals of any of the following industry types 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 as long as they have the required three years of on-the-job experience. Those who have completed their post graduation will need to have 2 years of on-the-job experience and those who have completed their PhD will need to have 1 year of on-the-job experience. Selection will be based on the participant’s profile. IGMPI reserves the right to reject any application with full fee refund.

Registration

The registration dates for this certification run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the certification lectures, videos and study material easily accessible. This gives huge window of self regulated and self-paced performance to the participants. After registration confirmation by the institute, required study resources, assessment test papers will be dispatched to the participants. This study material is considered sufficient for the preparation of the certification exam. However, the participants should feel free to go through other study resources and resources as well. The certification examination will be notified after 2 months of the registration.

Certification and Membership Fees

Rs. 6000/- for Indian nationals and 500 USD for overseas Professionals. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500 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 certified as GCP Professional 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.

Corporate Relations

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 Professionals 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.

For further enquiries or Handbook, write to or call us on:

[email protected]/+91 8130924488

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