Medicines are only as good as the people making them, points out Martin Lush, Global Vice President, Pharma Biotech and Medical Devices, NSF Health Sciences. In an email interaction with Viveka Roychowdhury, he explains how the NSF-IDMA ‘Advanced Program in Pharmaceutical Quality Management (APPQM) will provide companies with ‘rounded’ professionals who will help senior management sleep easier at night
What does the NSF certification mark mean to the pharma and biotech industries?
NSF was established in 1947 to improve global health. It is an internationally recognised, respected and trusted certifying body. What does this mean for the Indian pharma biotech industry and those attending NSF IDMA APPQM? It means those who pass the course’s assessments have met the standards required and have the knowledge to improve their companies’ regulatory compliance, competitive advantage and reduce risk.
What are the services NSF International provides to this sector?
Our objective is to leave clients better off than when we found them. More profitable, more compliant and more resilient (future proofed). Our services include consultancy support, benchmarking, education, auditing and remediation. But with a difference. Our education courses, like the APPQM, change the way people think. Our auditing and consultancy services help simplify operations to improve efficiency as well as compliance. And when clients get into trouble with regulatory agencies our remediation services leave our clients stronger, not weaker. We just treat our clients in the way we would like to be treated. With humility and respect.
NSF International’s staff is a mix of former regulatory agency staff and experienced industry professionals and in fact provides training to regulators from eight regulatory agencies, including agencies in the US and the EU. Can you give us a sense of how this unique edge translates into consulting, course content and classroom insights, etc. for your clients in the pharma sector?
We handpick our team based on two things. Character and experience. The NSF team have a character that is caring and totally committed to our clients. Most have 30+ years ‘hands on’ experience across the product lifecycle. From research through to manufacturing and quality assurance. Some are world experts in their field. All are inspirational leaders, mentors and course tutors. This unique blend of leadership experience, industry knowledge and technical/ scientific expertise provide students with a unique learning opportunity. As part of the APPQM, programme delegates will be assigned a personal course tutor. This 1:1 mentorship programme will accelerate delegates personal and professional development and create life long friendships
As Global Vice President of Pharma Biotech and Medical Devices for NSF International, what is your perspective on the fact that for the past two years, pharma companies in India are the subject of many warning letters indicating decreasing GMP compliance?
India is the number one supplier of generic medicines in the world so it’s not surprising it gets a lot of regulatory attention, including a growing percentage of Warning Letters. In the main these are due to failure to translate GMP requirements from the paper (policies and SOPs) into practice on the shop floor. We must remember, medicines are only as good as the people making them. The APPQM course will provide delegates with not just the technical knowledge needed, but the leadership skills to inspire and motivate others to follow the rules. Many companies have also been criticised for not adopting modern concepts of Quality Management and manufacturing practices. Those attending the APPQM course will learn the very latest thinking and best industry practices across the product life cycle.
How critical is the shortage of skilled staff in this sector in India? What is the global trend on this aspect?
There is an acute shortage of experienced and knowledgeable people globally. Not just in India. This shortage is costing our industry billions of dollars weekly because of one thing. Poor decision making. To make the right decision you must understand the science as well as the technical aspects of the manufacturing process. You also need to understand the GMP requirements, possess excellent risk based decision making skills and have the ability to influence others. This is what makes the APPQM so unique. We will blend all of these skills and requirements together to produce world class pharma professionals. Delegates attending the APPQM will get the equivalent of 10 years’ experience and knowledge condensed into just five modules. That’s what you call fast track development!
Having worked in several pharmaceutical manufacturing firms, holding senior leadership positions in the areas of quality assurance, quality control, development, supply chain, corporate auditing and governance, what is your take on the role of senior management in GMP compliance?
We all know that quality culture and GMP compliance starts at the top. Not by their ‘words’ but by their actions and behaviours. However, having worked in senior positions myself I know how busy and distracted leaders are. They can’t do everything. They can’t be everywhere. They must have people they can trust to ensure compliance standards are maintained, risks minimised and efficiencies improved. The APPQM will do just that. Provide companies with ‘rounded’ professionals capable of making the right decisions to improve profitability and improve compliance. Professionals who will help senior management sleep easier at night!
What are the advantages of the IDMA NSF course over other programmes?
The APPQM is unique in many ways. Firstly, the course tutors are world class experts with global knowledge and experience. Secondly, the residential format means delegates remain totally focussed during sessions including the 1:1 mentoring, another unique characteristic. Thirdly, delegates will learn by doing. Case studies, problem solving, discussions and debates will all ensure learning is embedded. Not forgotten. Another unique characteristic is that delegates will have access to NSF’s vast library of free resources as well as its subject matter experts. We also support our delegates outside the classroom. We will also establish an APPQM Alumni group to ensure delegates continue to develop and improve after completing the APPQM.
Though not a residential course, a facility for stay could be offered for the convenience of delegates. Wouldn’t this add to the cost per attendee?
For the reasons discussed above. The residential format is very cost effective because the quality of the learning is gravely improved. For people to learn they must be having fun. In our experience the residential setting creates an environment where delegates learn from each other as well as from the course tutors. Its all about creating an environment conducive to excellent learning.