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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
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Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years of experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. At Redica Systems, Jerry works with the machine learning and data science teams. They build computer models that examine enforcement actions and produce analyses the way an expert would in the past using hard copy documents and a highlighter. He is also an author of many articles detailing and analyzing current hot topics among the pharma industry, and international regulators appear on the Redica Systems Conference Spotlight page.
The essential thing in the pharma industry is that our goal is to make people’s lives better. And this goal has remained the same over time. It’s a very noble goal too. And Jerry is happy to spend the better part of his life in its pursuit.
Over the years, minor changes have happened. Although technology has developed, the general attitude of the industry is still the same. It’s also a bit concerning that things haven’t changed much. One thing that hasn’t changed is that we only tend to react after the problem has put itself in front of us. We are always reactive. We are never proactive. FDA has issued most of its significant regulations only after disasters or tragedies, e.g., the passage of act against thalidomide in the 60s, etc.
One that has changed, or at least beginning to change, is the idea of quality as a value centre. The quality department has been historically seen as the bad guys who are hindrances to the launch of a product. People didn’t want to go into quality because there was little career progression there. Also, it wasn’t financially incentivizing as much as manufacturing.
In the past, there used to be no training for someone who joined the quality department. It was a passive learning process. The employers who were doing good in the manufacturing department were shifted into the quality department. So there was no proper system for the whole process.
But now things are changing. For example, a group based in Cincinnati called Pathway for Patient Health got together to figure out what they need to sustain their industry. And there, they recognized the lack of quality training. So they put together five courses after laborious work. These courses were available at first at Xavier University in Cincinnati only but are now available in a plethora of other universities.
Now, one can choose to go into quality rather than just ending up there. You can select any science major, e.g. chemistry or biology and choose quality as a minor. At Jerry’s company Redica Systems, they offer such courses to interested people. It provides a ground running to them to become the next quality leaders of various companies.
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FDA has these regulations that require appropriate training and experience to execute one’s job in the pharma industry, and they are pretty detailed. How it has translated for the companies is that the employees should have a basic knowledge of science. For example, if you’re manufacturing a biological product, you need to understand the manufacturing regulations and the science behind it.
However, the regulations by FDA are subject to interpretation. And this interpretation has not been consistent across all the companies. But recently, companies have been working to build uniform and objective coursework in the quality domain.
This course not only has classroom learning but also includes mentoring, shadowing opportunities, and experimental learning.
Among the courses that have been recently developed are about global regulatory and legal requirements. They offer an in-depth study of the national and international regulations. Another course on product development is concerned with learning about what goes into product development and how it is scaled up from manufacturing. They teach about the product specifications and how is that important etc.
Another course is on the subject of risk and analysis failure to investigate and document manufacturing deviations that are risk factors and sometimes lead to a loss of the product in the market.
There’s a miniature course on microbiology because it is a crucial aspect of the pharma industry. Lastly, there’s a course on business acumen. This course focuses on how businesses are run and where the quality fits into the big picture.
These training courses also focus on the leadership training of the individuals. There’s a bad practice going on in many companies that are doing more harm than good. The people who show the potential to be promoted into senior positions are rotated into different roles in a company. This helps them to have a basic understanding of all the working parts of the company. But it becomes counterproductive. Because by the time you are starting to develop a good understanding of one role, say quality management, you are moved into another department and so on.
So, these people remain in a constant training mode and cannot settle comfortably into a specific position. They don’t add value to the company. Another problem with this approach is that companies don’t evolve for the better. The observations by the regulatory agencies remain the same because nobody sticks around long enough to make a positive change in the status quo.
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Big companies are now working to install training programs at the university level so that students get prior exposure to the industry before joining the company. This provides a baseline for those who’ll join the pharma industry and start working with a background towards a more specialized area. The same companies also offer internal training programs to their employees after they’ve joined it.
Go to the second part of the talk: Why We Need New Technology in GMP and What Stops Us
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Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years’ experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. He designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the U.S. and internationally. Chapman was founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010. He was Senior Editor at International Pharmaceutical Quality for six years; Editor-in-Chief for Xavier Health; has been an invited speaker at PDA, AAPS, ISPE, and RAPS events; and has served as a consultant to the animal health and compounding pharmacy industries. At Redica Systems, Chapman works with the machine learning and data science teams building computer models that examine enforcement actions and other data and produce analyses the way an expert would in the past using hard copy documents and a highlighter. His articles detailing and analyzing current hot topics among the pharma industry and international regulators appear on the Redica Systems Conference Spotlight page.
In this podcast with Kurt In Albon, we will look at the concept of true leadership and its importance in the pharmaceutical industry. Kurt will tell us what essential qualities […]
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