You are invited to attend the December meeting of the Atlanta Metro Chapter, Georgia Society of Professional Engineers, on December 11th!
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Everyone wants to trust the medicines and supplements they depend on their health and quality of life. People expect safe and effective medicines. Moreso than most products, consumers are not aware of the principles and intricacies involved in making drugs. They have no idea of the need for grinders, granulators, mixers, reaction vessels, spraying systems, blenders, weighing systems, piping, flow meters, filtration equipment, dryers, tableting presses, packaging machines, and many more devices. Without thinking about it, they rely on those with engineering and scientific training and skills to develop and run pharmaceutical manufacturing facilities, including all the logistics involved, the required Good Manufacturing Practices (GMPs) and federally regulated standards. Quality must be designed into the manufacturing processes. Qualified and trained employees use systems to monitor and document those processes in order to provide traceability and to ensure product quality. The Food and Drug Administration (FDA) establishes standards and enforces the laws for all drugs manufactured here or imported into the United States. But more than this, pharmaceutical manufacturers are expected to “DO The Right Thing”. The chemical, mechanical and industrial engineers that work in the pharmaceutical industry have a professional obligation to this cause. One might argue that the more important obligation is the moral obligation by which professional engineers are licensed, the obligation to hold the public welfare health and safety paramount.
Michael T. Williams, Director of Manufacturing and Technical Operations at Mikart, LLC will present on 21st Century Pharmaceutical Engineering. Mr. Williams will discuss pharmaceutical technology and engineering in today’s regulatory and work environment. He will discuss the basics of manufacturing prescription oral dose and liquid drugs. Also, he will discuss ethics stemming from the moral and legal obligations of pharmaceutical engineers to safeguard the public welfare, health, and safety, and will give examples of FDA findings to guide consideration of situations that may arise when designing manufacturing processes.
Michael T Williams, LSSBB, a south Alabama native, graduated with a Bachelor of Science in Chemistry (BS) from Alabama A & M University in 1987. He earned the Lean Six Sigma Black Belt (LSSBB) in 2010, certified by The George Group, LLC, by working on several projects for various manufacturing companies. His career includes experience working with manufacturing companies in R&D Labs, Plastics, Oil & Gas, Chemicals, Medical Devices, and Pharmaceuticals. Michael has held leadership positions in Technical Operations, Quality Systems, Commercial Operations, and Business Development. He has held multi-site responsibility for manufacturing in the U. S. and international work assignments in Japan and Germany. He has received multiple company awards for innovation and leadership achievements. He is the owner/principal consultant of HFC Enterprises, LLC where he has worked with both large and small pharmaceutical manufacturers such as Osmotica Pharmaceutical, Unither Pharmaceuticals, Pfizer Pharmaceuticals, and PAI Pharma Inc.
MEETING LOGISTICS:
- The face-to-face gathering will start at 6:00.
- Please note our return to the pre-pandemic location of Piccadilly Cafeteria in Tucker
- The meeting presentation will be recorded and available for later viewing at no cost.
- This presentation, like the previous presentations, will qualify for a required engineering professional development hour (PDH).
- Currently registered professional engineers, those engineers aspiring to become PEs, and others engaged in engineering would benefit from the presentation. Anyone in the field of engineering and members of the general public is welcome to pose discussion topics and to learn about engineering and public welfare.
About GSPE Atlanta Metro Chapter: The 200-member GSPE Atlanta Metro Chapter serves registered professional engineers and developing engineers by providing networking and continuing education opportunities. The local chapter also serves the wider metro Atlanta community as an information resource and contact for the engineering profession. Members, locally and across the state, actively support MATHCOUNTS®, a nationwide competitive program that has promoted excellence in middle school studies of mathematics for over thirty years. The GSPE also awards college engineering scholarships each year. GSPE members are often asked to address school classes to talk about applications of science and technology.