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
Any Life sciences graduate/B Pharm/ M. pharm, MSc in science disciplines/ any diploma /degree holders. Working professionals of any of the following industry types Drugs or Food 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 certification.
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.
A one-time fees (lump sum paid at beginning of the certification) of Rs. 20,000/- (600 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.
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.
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.
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.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like