This inaugural conference will provide detailed information and timely answers to questions about the application of cGMPs for human, animal, and biological drugs and fundamental requirements for manufacturing medicinal products. Guidelines, case studies, pitfalls and solutions will be extensively discussed by experts in the pharmaceutical and regulatory field. Possible causes for a regulatory action (which often results into a warning letter) will be presented. The audience will have plenty of opportunity to actively participate in lively discussions with experts on the topic.