My career of nearly 40 years in the pharmaceutical industry has included positions in development, manufacturing, and quality, at the manufacturing plant, site, and corporate levels. I designed and implemented a comprehensive “GMP Surveillance” process at Eli Lilly and again as a consultant at a top five animal health firm. The process is designed to identify pertinent GMP regulations, inspection findings, trends, and related information; then analyze the importance to the company, communicate appropriately, and archive that knowledge. Keeping current and compliant with GMPs is critical to the pharma and animal health industries. I can help your company set up a GMP Intelligence process to help perform this function, or enhance one you may already have in place. Contact me for more information.
As Chief Information Officer and Senior Editor at International Pharmaceutical Quality (IPQ) for six years, I traveled internationally to conferences, attending sessions and conducting interviews to produce in-depth reports on topics of interest to both industry and regulators in the drug GMP and CMC space. I developed a clear and concise writing style to convey complex ideas and relationships in simple terms. Click here for examples. I can cover your conference events and produce professional reports on the content. The articles can be used to showcase and promote your events. Contact me for more information.
As a consultant working for a top five animal health firm in 2016 and 2017, I learned about the nuances of the animal health industry, and designed, built, and implemented a real-time Quality Knowledge Management (QKM) tool based on the output from the GMP Surveillance process. QKM is a set of business processes that combines information from numerous sources and turns it into knowledge. It makes the knowledge available wherever it is needed to inform the work being done to help achieve the company's quality and compliance objectives. As such, it is a key element in quality management. No tool performing the same functions is commercially available. That tool can be built and implemented in most regulated industries, can be customized for each company, and is designed to be a “one-stop-shop” for quality regulatory information and quality knowledge management -- providing a competitive advantage and key success factor. I can help your company build this valuable tool and customize it for internal use. See the QKM page on this site for more information.