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NSF International is partnering with the Indian Drug Manufacturers’ Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education programme in Bangalore, India.
Pharmaceutical industry professionals that complete this graduate-level, advanced education programme will earn an internationally recognised certification in good manufacturing practice (GMP) compliance from NSF International and IDMA.
The Advanced Program in Pharmaceutical Quality Management consists of five modules, each lasting four days. With the modules taught every other month, the programme can be fully completed in 10 months. Classes will be offered at Acharya College in Bangalore, with a planned start in September 2017.
Pre-registration information sessions will be held in Bangalore, Hyderabad, and Mumbai during the week of 12 February. The information sessions will be led by S.V. Veerramani, national president of IDMA, S.M Mudda, chairman of the IDMA Regulatory Affairs Committee and program coordinator, and program tutor Martin Lush, global vice-president of pharmaceutical, biotech, and medical devices for NSF International. The event in Hyderabad is sponsored by the Pharmaceutical Export Promotion Council (PHARMEXCIL) and organised by the Ministry of Commerce and Industry of the Government of India.
India has the highest number of GMP-approved manufacturing plants outside the US and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. According to a report by Deloitte, 64% of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth.
S.V. Veerramani said: "India is one of the world’s largest producers of generic pharmaceuticals and IDMA is aware of the changing global regulatory expectations that require a focus on holistic management of quality rather than compliance with minimum regulatory standards.
"IDMA believes that education and development of quality leadership in the industry would serve as a foundation for continued compliance and for building a culture of quality.
"We are pleased to partner with NSF International to customise its world-class pharmaceutical quality management education program for the Indian pharmaceutical industry."
NSF International’s Advanced Program in Pharmaceutical Quality Management is taught by world-recognised leaders in PQM. The course tutors each have more than 30 years of global pharmaceutical industry experience. Several are former Medicines and Healthcare products Regulatory Agency (MHRA) inspectors and others have authored guidance documents for the World Health Organisation (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
In addition to training pharmaceutical industry professionals, NSF International has provided training to regulators from eight regulatory agencies, including agencies in the US and the EU.
Martin Lush said: "This program provides the training needed to comply with GMP requirements in Europe and the US.
"Together with IDMA, we’re going to change how course participants think about quality and give them the knowledge and tools they need to protect their company’s legacy, reputation and future."
The training programme is designed to be highly interactive and includes modules covering best practices in PQM systems, change control, and deviations, as well as human factors in quality management, practical application of statistics, and process validation and technology transfer.
The course also includes practical instruction on the leadership and communication skills required to improve business performance and regulatory compliance at pharmaceutical manufacturing operations, as well as how to successfully interact with regulatory agencies in the US and the EU.
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