Institute of Good Manufacturing Practices India
Global accredited training 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
Incorporated under Ministry of Corporate Affairs, Government of India
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD – Certificate of Merit 2015

Trusted by training participants in over 20 countries


CERTIFIED PROFESSIONAL IN  DATA INTEGRITY

Data integrity is an integral part in a pharmaceutical quality system which ensures that medicines are of the required quality. This certification provides with the following details as the difference between human error and a data integrity breach, common types of mistakes and how to prevent them, correction of unintentional data errors and responsible person for data integrity.

The case study based approach in 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 GMP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration.

Good Manufacturing Practices and its Regulations

Good Documentation Practices and Record Keeping

Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation

Importance and Principle of Data Integrity

Developing the Data Integrity Plan and Guidance document on Data Integrity

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

A one-time fees (lump sum paid at beginning of the certification) of Rs. 10,000/- (300 USD for overseas students) is mandatory. This covers the certification registration fee and examination fee. An additional membership fee of Rs 4500/-( USD 125 for overseas) is optional to pay 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 for each module. After successful completion the participants will be certified as professional in Data Integrity by IGMPI. For all the above mentioned modules elaborate study resources, Assessment test paper 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 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.

How to apply

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

[email protected]/+91 8130924488

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