This interactive online course reviews the key industry segments for chemical, biological, gas, medical devices, and diagnostics that manufacture pharmaceutical products. Several drug dosage forms are discussed including oral solids and liquids, suppositories, creams and ointments, aerosols and inhalants, sterile injectables and transdermal. Also covered is the manufacture of pharmaceuticals and the different mechanisms for administering drugs including how the various drugs are made through chemical synthesis, granulation, mixing/blending, milling, drying, compression, coating, filling, and packaging. This course is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge. At the conclusion of this course, participants will be able to have a better understanding of the basic steps for:
- Solid dose manufacturing including chemical synthesis/extraction, granulation, mixing, milling, drying, compression/encapsulation, coating, filling and packaging
- Liquid dose manufacturing including chemical synthesis/extraction, compounding, filter solution, fill product, packaging
- Biological manufacturing including manufacturing the biologically derived API, separation, purification, compounding, filter, and filling, as well as
- The ways drugs are administered for creams and ointments, transdermal and aerosols and inhalants
The course includes pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed.
Attendance suggested for:
- Professionals who are new to the industry or have new work assignments that need to gain knowledge about the industry, its challenges, and regulations.
- Professionals with industry experience that want a refresher.
- Suppliers and service providers to the industry, who design, construct, validate and finance facilities.
- Individuals who support the industry through training, marketing, economic development and personnel placement.
- Individuals with responsibility for: Clinical / Investigational Products Operations / Manufacturing Process Development / Technology Transfer Quality Assurance / Control Research and Development.
Ronald Filipski graduated from the University of Cincinnati in 1972 with a BS in biology/chemistry, and obtained an MBA in business management from Fairleigh Dickinson University in 1980. Filipski has been in the pharmaceutical industry for more than 30 years. Since 2000, he has been an operations and compliance consultant for the pharmaceutical industry. Prior to becoming a consultant, he spent 12 years with Aventis Pasteur as the Director of Filling, Packaging and Warehousing. Prior to Aventis Pasteur, he spent 12 years with Hoffmann LaRoche and three years with Zenith Laboratories. He has extensive experience not only with operations, but with the development of contract manufacturing, auditing and compliance. He holds a certification from the Institute of Packaging Professionals and is an active member of ISPE.