Training for pharma entrepreneurs
Avinash Mishra In house consultant – Pharma
Only 60 production locations of Indian pharma sector have been certified by the World Health Organisation (WHO), which implies they comply with the strict quality standards imposed by the US Food and Drug Administration (FDA). Compliance with FDA standards is the precondition for selling products on the important US market, but in process of doing so, medium scale and small scale industries face many challenges.
Indian pharma companies need to improve their quality standards. In order to do that, Indian companies have to follow international pattern where employee training ensures adherence to regulatory requirements and quality standards. Due to a lack of awareness and knowledge among employees, companies give them training in Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), so they can be competent enough to maintain norms and regulatory requirements of global pharma industry. The trainer should have a vast experience of pharma industry and should proactively assist during audits, to prevent the company officials from getting cold feet.
The company management should give some GMP training to everyone, including contract, temporary and consulting personnel as everyone in an organisation needs to have some ‘GMP literacy’. A Current Good Manufacturing Practices (cGMP) training course provides a background of the FDA’s cGMP regulations through a review of the regulatory requirements under Title 21 of the Code of Federal Regulations (CFRs). Successful completion of this training course will assist and allow employees with implementation of process validation, establishment and maintenance of audit programmes, quality control and process failure procedures/programs, maintenance programmes for cGMP equipment, and implementation of a document control programme.
What MITCON offers
MITCON is a 25 year old consultancy organisation promoted by financial institutions, banks and state organisations, providing total consultancy and training services to existing and new entrepreneurs covering diverse industry sectors. We offer skill based training to graduate, entrepreneurs, farmers, researchers in the form of GMP workshops, certificate courses on clinical research, IPR and regulatory affairs. We also conduct programmes in drug quality control and testing, entrepreneurship development programme in pharma and biotech. With class sizes that are limited to 40 attendees and experienced GCP trainers, candidates can be sure that they get the personal attention needed.
Aspirants and entrepreneurs can browse through MITCON’s proven GCP training courses to find the right one to meet their specific needs or, MITCON can build a custom GCP training course
MITCON is also the leader the most cutting-edge Good Laboratory Practices (GLP) training available.
Our comprehensive curriculum of online and public courses run one to five days in length and include discussions, case studies, and group problem-solving exercises which are taught by top industry leaders who share their knowledge in an enthusiastic, interactive manner.