Center for Professional Innovation & Education (CfPIE), Berlin, Germany
April 26 & 27, 2012
This is a course for people who must write process documents required by FDA and international regulations. Process documents create a procedural infrastructure that delineates the company’s activities. These documents include Standard Operating Procedures (SOPs); policies; work instructions; laboratory methods; emergency action, chemical hygiene, animal husbandry and other plans; and quality manuals. This course is valuable for pharmaceutical, medical device, and biotech professionals in drug discovery, product development, quality assurance, clinical testing, information technology, and regulatory affairs. It will also be of benefit to senior and middle management executives who want to familiarize themselves with the regulations that mandate procedures, and the industry standards for writing them, putting them in place, and remaining compliant.
|
|