NSF International, a global public health and safety organization, is partnering with the Indian Drug Manufacturers’ Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education program in Bangalore, India.
Pharmaceutical industry professionals who complete the graduate-level, advanced education program will earn an internationallyrecognised certification in 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 program can be 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, 2017. The information sessions will be led by S.V. Veerramani, National President of IDMA, S.M Mudda, Chairman of the IDMA Regulatory Affairs Committee & Program Coordinator, and program tutor Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. The event in Hyderabad is sponsored by the Pharmaceutical Export Promotion Council (PHARMEXCIL) and organized by the Ministry of Commerce and Industry, Government of India.
India has the highest number of GMP-approved manufacturing plants outside the United States 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 percent of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth.
“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,” said S.V. Veerramani, National President of IDMA. “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 Organization (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 United States and the European Union (EU).
“This program provides the training needed to comply with GMP requirements in Europe and the United States,” said Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. “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 program is designed to be highly interactive and includes modules covering best practices in PQM systems, change control and deviations, 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 and to successfully interact with regulatory agencies in the United States and the EU.
About NSF International: NSF International (nsf.org) is a global independent organization that writes standards, and tests and certifies products for the health sciences, water, food and consumer goods industries to minimise adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 165 countries, NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Centre on Food Safety, Water Quality and Indoor Environment.
NSF International’s health sciences services include training and education, consulting, auditing, GMP and GLP analytical testing, DNA testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device, dietary supplement, cosmetic and bottled water/beverage industries throughout the product lifecycle. NSF International wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
About IDMA: The Indian Drug Manufacturers’ Association (IDMA) is a leading association of Indian pharmaceutical manufacturers with over 1,000 members. The objective of IDMA is to foster industry growth by focusing on patient welfare and promoting quality and business excellence in the sector. IDMA is the voice of the national sector and works in close collaboration with the government, regulatory agencies, academia and other associations for the progress of the industry.