These guides summarize the latest regulations and guidances issued by the FDA and the regulatory authorities in Canada, the European Union, and Japan; provide detailed analysis of these regulations; and provide practical advice and examples of how best to implement them. The aim of the guides is to provide simple and concise interpretation of these regulations and to provide effective solutions for their implementation in the development manufacturing, pilot plant, manufacturing facility, and clinical trial sites.
These .PDFs were published in 2015 and are offered at 20%+ discount from the individual prices. These reports are available in hard copies upon request. Please note that hard copy versions of all three guides are available for a total of $1,499.00 plus any applicable taxes and shipping and handling.